HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 Linux 06APR21:22:51:3406APR21:22:51:34 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS ADDV SASDATA 9.4 Linux 06APR21:22:51:3406APR21:22:51:34 HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000006700000000000000000000 STUDYID Study Identifier USUBJID Unique Subject Identifier DOMAIN Domain Abbreviation SUBJID Subject Identifier for the Study SITEID Study Site Identifier (AGE Age ,SEX Sex 4)RACE Race 5 TRTSDT Date of First Exposure to Treatment DATE ^ TRTEDT Date of Last Exposure to Treatment DATE f ARM Description of Planned Arm n ARMCD Planned Arm Code  ACTARM Description of Actual Arm  ACTARMCDActual Arm Code TRT01P Planned Treatment for Period 01 TRT01A Actual Treatment for Period 01 TRT01PN Planned Treatment for Period 01 (N) TRT01AN Actual Treatment for Period 01 (N)  AGEGR1 Pooled Age Group 1 AGEGR1N Pooled Age Group 1 (N) DVSEQ Sequence Number  DVSPID Sponsor-Defined Identifier DVTERM Protocol Deviation Term (2DVTERM1 Protocol Deviation Term 1 DVDECOD Protocol Deviation Coded Term "EPOCH Epoch 9ACTSITE Actual Site of Deviation Occurrence M!DESGTOR Visit Designator Q#CAPE Confirmed Analysis Population Exclusion r DVCAT Category for Protocol Deviation  DVSTDTC Start Date/Time of Deviation  DVSTDY Study Day of Start of Deviation !ASTDT Analysis Start Date DATE "PREFL Pre-treatment Flag #TRPFL On Treatment Flag $RANDFL Randomized Population Flag %PHASE Study Phase &PHASEN Study Phase (N) K'COHORT Cohort Group (COHORTN Cohort Group (N) &4)DOSALVL Actual Dosing Level .*DOSALVLNActual Dosing Level (N) b4+DOSPLVL Planned Dosing Level j,DOSPLVLNPlanned Dosing Level (N) -DS3KFL Phase 3 3000 Subjects Flag .AGEGR3N Pooled Age Group 3 (N)  /AGEGR3 Pooled Age Group 3 0AGEGR4N Pooled Age Group 4 (N)  1AGEGR4 Pooled Age Group 4 2HIVFL HIV Positive Subjects Flag 3AGETR01 Age at Vaccination 01 4TRTSDTM Datetime of First Exposure to Treatment DATETIME 5TRTEDTM Datetime of Last Exposure to Treatment DATETIME 6TR01SDTMDatetime of First Exposure in Period 01 DATETIME 7TR01EDTMDatetime of Last Exposure in Period 01 DATETIME 8TR02SDTMDatetime of First Exposure in Period 02 DATETIME 9TR02EDTMDatetime of Last Exposure in Period 02 DATETIME %:VAX101 Vaccination 01 $;VAX102 Vaccination 02 +$VAX202 Vaccination 04 ?VAX20U Vaccination Unplanned in Period 02 @VAX20UDTVaccination Date Unplanned in Period 02 DATE AUNBLNDDTTreatment Unblinded Date DATE BMULENRFLMultiply Enrolled Subjects CRAND1FL Random - exclude Multi-Enrolloer  HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 C4591001C4591001 1001 10011001DV100110011001BFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1JI8LRAProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-04-30.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1001 10011001DV100110011001BFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A 1-1LGBQFBProcedure/Test not performed per protocol Procedures/Tests SCREENING 1001SCR NO Non-Important2020-06-08.DV: NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1001 10011002DV100110021001BFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JI8LREProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-04-30.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1001 10011003DV100110031001B(MWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1JI8M0OProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-01.DV NNPhase 1 A . . .NA 18-55 Years. NB(...... .. NC4591001C4591001 1001 10011004DV100110041001B*FWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A 1-1JI8M0SProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-010DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB*Hq\Hq"8Hq\Hq"8..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011004DV100110041001B*FWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A01-1K3AOWBProcedure/Test not done Procedures/Tests VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-05-26BDV- YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB*Hq\Hq"8Hq\Hq"8..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011004DV100110041001B*FWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A@1-1KM4RCBProcedure/Test performed out of window Procedures/Tests FOLLOW-UP 1001V6_WEEK2_POSTVAX2_S NO Non-Important2020-06-09B%DV; YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB*Hq\Hq"8Hq\Hq"8..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011005DV100110051001B)FWHITE DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A@1-1JI8M0WProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-04 DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB)Hq݈Hq Hq݈Hq ..Placebo Placebo .DV YC4591001C4591001 1001 10011005DV100110051001B)FWHITE DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0AP1-1K3AOWFProcedure/Test not done Procedures/Tests VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-05-26BDV- YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB)Hq݈Hq Hq݈Hq ..Placebo Placebo .DV YC4591001C4591001 1001 10011005DV100110051001B)FWHITE DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A`1-1KM4RCEProcedure/Test performed out of window Procedures/Tests FOLLOW-UP 1001V6_WEEK2_POSTVAX2_S NO Non-Important2020-06-09B#DV; YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB)Hq݈Hq Hq݈Hq ..Placebo Placebo .DV YC4591001C4591001 1001 10011005DV100110051001B)FWHITE DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A01-1OAJFURLab performed out of window Laboratory FOLLOW-UP 1001COVID_A NO Non-Important2020-12-03BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB)Hq݈Hq Hq݈Hq ..Placebo Placebo .DV YC4591001C4591001 1001 10011005DV100110051001B)FWHITE DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1RRSIN1Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001V4_WEEK3_VAX2_S YES-POP2,YES-POP3 Important 2020-12-23BDW YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB)Hq݈Hq Hq݈Hq ..Placebo Placebo .DV YC4591001C4591001 1001 10011005DV100110051001B)FWHITE DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1RRSIMXReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001V4_WEEK3_VAX2_S YES-POP2,YES-POP3 Important 2021-01-14BDW YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB)Hq݈Hq Hq݈Hq ..Placebo Placebo .DV YC4591001C4591001 1001 10011006DV100110061001BMWHITE DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1KXT62PProcedure not performed as part of vital signs. Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-04 DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqpHqihHqpHqih..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011006DV100110061001BMWHITE DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A 1-1JI8M10Procedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-04 DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqpHqihHqpHqih..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011006DV100110061001BMWHITE DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A01-1K3AOWIProcedure/Test not done Procedures/Tests VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-05-27BDV. YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqpHqihHqpHqih..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011006DV100110061001BMWHITE DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A@1-1KM4RCRProcedure/Test performed out of window Procedures/Tests FOLLOW-UP 1001V6_WEEK2_POSTVAX2_S NO Non-Important2020-06-09B#DV; YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqpHqihHqpHqih..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011007DV100110071001BMBLACK OR AFRICAN AMERICAN DVDV/BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JI8M14Procedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-04 DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq@HqHHq@HqH..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011007DV100110071001BMBLACK OR AFRICAN AMERICAN DVDV/BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A01-1KL8O1LVisit not done Visit Schedule VACCINATION 1001Unschedule Teleheath Visit NO Non-Important2020-05-20ADV' YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq@HqHHq@HqH..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011007DV100110071001BMBLACK OR AFRICAN AMERICAN DVDV/BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A 1-1KM4RCUProcedure/Test performed out of window Procedures/Tests FOLLOW-UP 1001V6_WEEK2_POSTVAX2_S NO Non-Important2020-06-09B#DV; YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq@HqHHq@HqH..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011008DV100110081001BMWHITE DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A 1-1JI8M1IProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-04 DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqHqHq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011008DV100110081001BMWHITE DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A01-1K3BWG3Procedure/Test not done Procedures/Tests VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-05-27BDV. YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqHqHq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011008DV100110081001BMWHITE DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A@1-1KM4RCXProcedure/Test performed out of window Procedures/Tests FOLLOW-UP 1001V6_WEEK2_POSTVAX2_S NO Non-Important2020-06-08B"DV: YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqHqHq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011008DV100110081001BMWHITE DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1KQTA2EOther Informed Consent Informed Consent FOLLOW-UP 1001Consent NO Non-Important2020-06-25B3DVK YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqHqHq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011009DV100110091001B(MASIAN DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JFBTJHOther Informed Consent Informed Consent SCREENING 1001Consent NO Non-Important2020-05-04 DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB(Hq޴HqjHq޴Hqj..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011009DV100110091001B(MASIAN DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A01-1KXT62TProcedure not performed as part of vital signs. Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-04 DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB(Hq޴HqjHq޴Hqj..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011009DV100110091001B(MASIAN DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A@1-1JI8M1MProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-04 DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB(Hq޴HqjHq޴Hqj..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011009DV100110091001B(MASIAN DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A 1-1L9JOW0Subject was vaccinated despite meeting temporary delay criterion #1 (current febrile illness or other acute illness within 48 hrs before study intervention administration. Includes current symptoms that could represent a potential COVID-19 illness.Investigational ProductVACCINATION 1001V1_DAY1_VAX1_S NO Non-Important2020-05-06ADV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB(Hq޴HqjHq޴Hqj..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011009DV100110091001B(MASIAN DVDV.BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0AP1-1K3BWG6Procedure/Test not done Procedures/Tests VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-05-27BDV. YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB(Hq޴HqjHq޴Hqj..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011010DV100110101001B3MWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1JP0N6SProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-05.DV NNPhase 1 A . . .NA 18-55 Years. NB3...... .. NC4591001C4591001 1001 10011011DV100110111001B FWHITE DVDV3BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A01-1JP0N6VProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-05`DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB HqWHqTHqWHqT..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW3 YC4591001C4591001 1001 10011011DV100110111001B FWHITE DVDV3BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A 1-1K8KYZDProcedure not performed as part of vital signs. Procedures/Tests VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-01BDV3 YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB HqWHqTHqWHqT..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW3 YC4591001C4591001 1001 10011011DV100110111001B FWHITE DVDV3BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A1-1R0YDKLNasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1001COVID_A NO Non-Important2020-12-31BDW YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB HqWHqTHqWHqT..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW3 YC4591001C4591001 1001 10011012DV100110121001B2MASIAN DV DV5BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A1-1JP0N6YProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-05DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB2HqHq4HqHq4..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011013DV100110131001BFWHITE DV%DW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0AP1-1JP0N7BProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-05DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrHqHr HrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011013DV100110131001BFWHITE DV%DW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1LKF7CPOther IP deviation Investigational ProductVACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrHqHr HrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011013DV100110131001BFWHITE DV%DW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A01-1KFHO1VNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrHqHr HrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011013DV100110131001BFWHITE DV%DW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A@1-1KFHO1SUrine pregnancy test not performed. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrHqHr HrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011013DV100110131001BFWHITE DV%DW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A127173801IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2021-01-18BDW YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrHqHr HrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011014DV100110141001B#FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JP0N7EProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-05.DV NNPhase 1 A . . .NA 18-55 Years. NB#...... .. NC4591001C4591001 1001 10011015DV100110151001BMWHITE DVDV3BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A1-1JP0N7HProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-06PDVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NBHq?HqtHq?Hqt..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011016DV100110161001B#MWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1JP0N7KProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB#...... .. NC4591001C4591001 1001 10011021DV100110211001BFWHITE DV'DW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0AP1-1JVJ258Procedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-07DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrޟHqHr HrśHrޟPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011021DV100110211001BFWHITE DV'DW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1LKF7CTOther IP deviation Investigational ProductVACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrޟHqHr HrśHrޟPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011021DV100110211001BFWHITE DV'DW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A01-1KM11HYNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrޟHqHr HrśHrޟPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011021DV100110211001BFWHITE DV'DW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A@1-1KM11HVUrine pregnancy test not performed. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrޟHqHr HrśHrޟPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011021DV100110211001BFWHITE DV'DW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A126632101IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductOPEN LABEL TREATMENT1001Vax 3 NO Non-Important2021-01-06BDW YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NBHqHrޟHqHr HrśHrޟPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011026DV100110261001B#MWHITE DV%DV|BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1JVJ25MProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-12`DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB#HqpHr0HqpHr0..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011026DV100110261001B#MWHITE DV%DV|BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1LKF7CYOther IP deviation Investigational ProductVACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB#HqpHr0HqpHr0..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011026DV100110261001B#MWHITE DV%DV|BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KFHOBFNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB#HqpHr0HqpHr0..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011028DV100110281001B5FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1JVJ25SUrine pregnancy test not performed. Laboratory SCREENING 1001SCR NO Non-Important2020-05-12DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5Hq*Hr exHq*Hr ex..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011028DV100110281001B5FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A@1-1JY98JVUrine pregnancy test not performed. Laboratory VACCINATION 1001V1_DAY1_VAX1_S NO Non-Important2020-05-20ADV' YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5Hq*Hr exHq*Hr ex..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011028DV100110281001B5FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0AP1-1JY98K0Urine pregnancy test not performed. Laboratory VACCINATION 1001V2_DAY2_POSTVAX1_S NO Non-Important2020-05-21A DV( YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5Hq*Hr exHq*Hr ex..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011028DV100110281001B5FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1LKF7EFOther IP deviation Investigational ProductVACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5Hq*Hr exHq*Hr ex..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011028DV100110281001B5FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KM4RBWNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5Hq*Hr exHq*Hr ex..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011028DV100110281001B5FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A`1-1KM11I1Urine pregnancy test not performed. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5Hq*Hr exHq*Hr ex..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011030DV100110301001B)FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1LKF7EJOther IP deviation Investigational ProductVACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB)HqHr THqHr T..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011030DV100110301001B)FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KM4RC2Nasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB)HqHr THqHr T..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011030DV100110301001B)FWHITE DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1KM4RBZUrine pregnancy test not performed. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB)HqHr THqHr T..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011032DV100110321001B#MWHITE DV'DV|BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1LKF7F9Other IP deviation Investigational ProductVACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB#Hq,Hr*Hq,Hr*..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011032DV100110321001B#MWHITE DV'DV|BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1LKF7FDNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB#Hq,Hr*Hq,Hr*..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011034DV100110341001BFASIAN DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A@1-1JVJ25PProcedure/Test not done Procedures/Tests SCREENING 1001SCR NO Non-Important2020-05-15PDV"YNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHq)HHr gHq)HHr g..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011034DV100110341001BFASIAN DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1LKF7EMOther IP deviation Investigational ProductVACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHq)HHr gHq)HHr g..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011034DV100110341001BFASIAN DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KM4RC8Nasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHq)HHr gHq)HHr g..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011034DV100110341001BFASIAN DV'DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1KM4RC5Urine pregnancy test not performed. Laboratory VACCINATION 1001V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHq)HHr gHq)HHr g..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011040DV100110401001BAMWHITE DV=DVRBNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA65-85 YearsA@A 1-1NRYTMXVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1001POT_COVID_CONVA NO Non-Important2020-10-28BDV YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =q10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBAHq&LHqʹ Hq&LHqʹ ..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011041DV100110411001BFFWHITE DV=DVRBNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA65-85 YearsA@A 1-1NZLLYLPotential COVID-19 illness visit not done when required per protocol. Visit Schedule FOLLOW-UP 1001POT_COVID_ILL NO Non-Important2020-08-28BODV YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =q10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBFHqHqͽHqHqͽ..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011041DV100110411001BFFWHITE DV=DVRBNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA65-85 YearsA@A1-1QYBYBEReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001Potential ReVax Initial Contact YES-POP2,YES-POP3 Important 2021-01-27BDW# YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =q10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBFHqHqͽHqHqͽ..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011042DV100110421001BGFWHITE DV=DVPPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1R6ZGTRReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001V4_WEEK3_VAX2_S YES-POP2,YES-POP3 Important 2021-02-10BDW1 YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =qPlacebo A`Placebo A`NA0>55 Years . NBGHq)Hq* Hq)Hq* ..Placebo Placebo .DW YC4591001C4591001 1001 10011042DV100110421001BGFWHITE DV=DVPPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A 1-1SSS15SPotential COVID-19 illness visit not done when required per protocol. Visit Schedule REPEAT SCREENING 1 1001POT_COVID_ILL NO Non-Important2021-02-15BDW6 YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =qPlacebo A`Placebo A`NA0>55 Years . NBGHq)Hq* Hq)Hq* ..Placebo Placebo .DW YC4591001C4591001 1001 10011043DV100110431001BJFWHITE DVADVXBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 65-85 YearsA@A 126637401IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-07BDVW YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQ20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBJHqVDHq HqVDHq ..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011043DV100110431001BJFWHITE DVADVXBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 65-85 YearsA@A128799601IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2021-03-11CDWN YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQ20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBJHqVDHq HqVDHq ..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011044DV100110441001BOMWHITE DV;DVOBNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA65-85 YearsA@A1-1SK6OGJReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001Potential ReVax Initial Contact YES-POP2,YES-POP3 Important 2021-02-04BDW+ YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =q10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBOHqtHqԤHqtHqԤ..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011046DV100110461001BAMWHITE DVDDVYBNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A065-85 YearsA@A1-1L3POMGSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsFOLLOW-UP 1001V4_WEEK3_VAX2_S NO Non-Important2020-07-16BDV` YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) A30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBAHqI HqHqI Hq..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011047DV100110471001BCFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1L24D3DOther Informed Consent Informed Consent SCREENING 1001Consent NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBC...... .. NC4591001C4591001 1001 10011048DV100110481001BBFWHITE DVBDVXBNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A065-85 YearsA@A 1-1LNZ1PPProcedure/Test not performed per protocol Procedures/Tests SCREENING 1001SCR NO Non-Important2020-06-08DV:YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) A30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBBHq$HqոHq$Hqո..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011048DV100110481001BBFWHITE DVBDVXBNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A065-85 YearsA@A01-1LNZ1PVProcedure/Test not performed per protocol Procedures/Tests SCREENING 1001SCR NO Non-Important2020-06-08DV:YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) A30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBBHq$HqոHq$Hqո..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011048DV100110481001BBFWHITE DVBDVXBNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A065-85 YearsA@A126637701IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-07BDVW YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) A30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBBHq$HqոHq$Hqո..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011049DV100110491001BDFWHITE DVADVVBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 65-85 YearsA@A126637901IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-05BDVU YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQ20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBDHqTHqXHqTHqX..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011052DV100110521001BAFWHITE DVCDVXBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 65-85 YearsA@A126638201IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-07BDVW YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQ20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBAHqHqլHqHqլ..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011053DV100110531001BEFWHITE DVBDVYPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A0126638401IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-08BDVX YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) APlacebo A`Placebo A`NA0>55 Years . NBFHqHqPHqHqP..Placebo Placebo .DW YC4591001C4591001 1001 10011053DV100110531001BEFWHITE DVBDVYPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1SKKCBAReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001Potential ReVax Initial Contact YES-POP2,YES-POP3 Important 2021-01-27BDW# YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) APlacebo A`Placebo A`NA0>55 Years . NBFHqHqPHqHqP..Placebo Placebo .DW YC4591001C4591001 1001 10011053DV100110531001BEFWHITE DVBDVYPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A 1-1SKKCBDReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001Potential ReVax Initial Contact YES-POP2,YES-POP3 Important 2021-02-24BDW? YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) APlacebo A`Placebo A`NA0>55 Years . NBFHqHqPHqHqP..Placebo Placebo .DW YC4591001C4591001 1001 10011055DV100110551001BCFBLACK OR AFRICAN AMERICAN DVCDVXBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 65-85 YearsA@A126638801IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-07BDVW YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQ20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBCHqHqhHqHqh..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011057DV100110571001BCFWHITE DVCDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A126638901IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-07BDVW YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQPlacebo A`Placebo A`NA0>55 Years . NBCHqHrHqHqծ(Hr͏HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011058DV100110581001BEFASIAN DVDDVYBNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A065-85 YearsA@A1-1KP8XJSSubject/LAR signed and dated ICD after screen/enroll date Informed Consent SCREENING 1001Consent NO Non-Important2020-06-150DVAYNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) A30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBEHqKHq0HqKHq0..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011058DV100110581001BEFASIAN DVDDVYBNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A065-85 YearsA@A 126639001IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-07BDVW YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) A30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBEHqKHq0HqKHq0..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011059DV100110591001BHFWHITE DVCDVXBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 65-85 YearsA@A126639101IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-07BDVW YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQ20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBHHq hHqHq hHq..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011061DV100110611001BDFWHITE DVDDVYBNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A065-85 YearsA@A126639201IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-08BDVX YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) A30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBDHqG@HqhHqG@Hqh..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011061DV100110611001BDFWHITE DVDDVYBNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A065-85 YearsA@A 1-1QSQ8I0Visit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1001COVID_A1 NO Non-Important2021-02-22BDW= YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) A30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBDHqG@HqhHqG@Hqh..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011064DV100110641001BFMWHITE DVDDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A 126639401IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-07-06BDVV YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) APlacebo A`Placebo A`NA0>55 Years . NBFHqr$HrδHqr$HqWDHroHrδPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011064DV100110641001BFMWHITE DVDDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A127436401IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductOPEN LABEL TREATMENT1001Vax 3 NO Non-Important2021-01-15BDW YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) APlacebo A`Placebo A`NA0>55 Years . NBFHqr$HrδHqr$HqWDHroHrδPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011069DV100110691001B%FWHITE DVQDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A126632201IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductOPEN LABEL TREATMENT1001Vax 3 NO Non-Important2021-01-05BDW YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQRPlacebo A`Placebo A`NA 18-55 Years. NB%HqopHrޞHqopHqHrS HrޞPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011070DV100110701001B3MWHITE DVQDVfBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 18-55 YearsA0A1-1KXT62XProcedure not performed as part of vital signs. Procedures/Tests VACCINATION 1001V1_DAY1_VAX1_S NO Non-Important2020-07-01ADVQ YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQR20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB3Hq̘HqEHq̘HqE..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011071DV100110711001B MWHITE DVQDVfBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 18-55 YearsA0A1-1L86RWNOther Informed Consent Informed Consent FOLLOW-UP 1001Consent NO Non-Important2020-07-29BDVm YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQR20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB HqpHq|HqpHq|..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011074DV100110741001BMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KU8SIEOther Informed Consent Informed Consent SCREENING 1001Consent NO Non-Important2020-06-24.DVJ NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1001 10011077DV100110771001B-MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KVEIHYOther Informed Consent Informed Consent SCREENING 1001Consent NO Non-Important2020-06-25.DVK NNPhase 1 A . . .NA 18-55 Years. NB-...... .. NC4591001C4591001 1001 10011081DV100110811001BHMWHITE DVlDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1R6ZGTVReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001V2_VAX2_L YES-POP2,YES-POP3 Important 2020-12-18BDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBHHqPHr 4HqPHr 4..Placebo Placebo .DV YC4591001C4591001 1001 10011081DV100110811001BHMWHITE DVlDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1R6ZGTYReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1001V2_VAX2_L YES-POP2,YES-POP3 Important 2021-01-07BDW YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBHHqPHr 4HqPHr 4..Placebo Placebo .DV YC4591001C4591001 1001 10011086DV100110861001B4MWHITE DVlDW/Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A127174001IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2021-01-19BDW YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB4Hq( Hr"Hq( Hr Hr%Hr"Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011087DV100110871001B-MWHITE DVlDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1PG70MRNasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1001COVID_A NO Non-Important2021-01-11BDW YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NB-Hq1lHr Hq1lHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011087DV100110871001B-MWHITE DVlDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1QSQ8I3Visit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1001COVID_A1 NO Non-Important2021-02-16BDW7 YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NB-Hq1lHr Hq1lHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011092DV100110921001B-MASIAN DVmDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A127174401IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2021-01-19BDW YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB-HqRHrtHqRHr Hr! HrtPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011093DV100110931001B;MWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1SSSMYLLab performed out of window Laboratory REPEAT SCREENING 1 1001COVID_A NO Non-Important2021-01-21BDW YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NB;HqmHr HqmHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011094DV100110941001BDFWHITE DVmDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 122771501IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-08-19BDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBDHqp,HrHqp,HrRHrѨHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011094DV100110941001BDFWHITE DVmDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA127174601IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2021-01-14BDW YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBDHqp,HrHqp,HrRHrѨHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011096DV100110961001B<FWHITE DVmDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA@1-1NA1I35Serology sample not collected at the convalescent visit. Laboratory VACCINATION 1001POT_COVID_CONVA NO Non-Important2020-08-15BDV~ YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NB<HqHr꼸HqHr<HrѕHr꼸Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011096DV100110961001B<FWHITE DVmDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 122772001IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-08-19BDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NB<HqHr꼸HqHr<HrѕHr꼸Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011096DV100110961001B<FWHITE DVmDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1NIACJBSerology sample not collected Laboratory FOLLOW-UP 1001POT_COVID_CONVA NO Non-Important2020-09-18B4DV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NB<HqHr꼸HqHr<HrѕHr꼸Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011096DV100110961001B<FWHITE DVmDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APAP1-1NSJ9PBVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1001POT_COVID_CONVA NO Non-Important2020-09-18B4DV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NB<HqHr꼸HqHr<HrѕHr꼸Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011096DV100110961001B<FWHITE DVmDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA127174801IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2021-01-14BDW YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NB<HqHr꼸HqHr<HrѕHr꼸Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011097DV100110971001B;MWHITE DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA122557601IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-08-21BDV YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NB;HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1001 10011098DV100110981223BNMWHITE DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA122772201IP verification incomplete Investigational ProductVACCINATION 1223Vax 2 NO Non-Important2020-08-20BDV YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NBNHq$HrhHq$Hrh..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011099DV100110991001BLFWHITE DVnDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1RRSIN5Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsOPEN LABEL TREATMENT1001Potential ReVax Initial Contact YES-POP2,YES-POP3 Important 2021-02-04BDW+ YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBLHqHr5HqHrhHr5Hr5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011100DV100111001001BEFWHITE DVnDW/Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1MP7X2BOther lab deviation Laboratory VACCINATION 1001Unplanned NO Non-Important2020-08-31B!DV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBEHqHr$,HqHr HrDHr$,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011101DV100111011001BMBLACK OR AFRICAN AMERICAN DVnDWEPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 122558501IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-08-20BDV YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NBHqHsHqHrSHr HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1001 10011101DV100111011001BMBLACK OR AFRICAN AMERICAN DVnDWEPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A127781101IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2021-02-08BDW/ YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NBHqHsHqHrSHr HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1001 10011102DV100111021001BFNOT REPORTED DVnDW@Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1MKV8KJSpecimen could not be analyzed Laboratory VACCINATION 1001V2_VAX2_L NO Non-Important2020-07-30ADVn YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NBHqHs HqHrrXHrİHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011102DV100111021001BFNOT REPORTED DVnDW@Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A122772501IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-08-19BDV YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NBHqHs HqHrrXHrİHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011102DV100111021001BFNOT REPORTED DVnDW@Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A@1-1P93YTUUrine pregnancy test not performed. Laboratory FOLLOW-UP 1001V101_VAX3 NO Non-Important2020-10-08BGDV YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NBHqHs HqHrrXHrİHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011102DV100111021001BFNOT REPORTED DVnDW@Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1OTBOKLLab performed out of window Laboratory FOLLOW-UP 1001COVID_A NO Non-Important2020-12-28BDW YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NBHqHs HqHrrXHrİHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011103DV100111031001B<MBLACK OR AFRICAN AMERICAN DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA122772701IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-08-20BDV YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NB<HqdHrHqdHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011104DV100111041001B@FWHITE DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 1-1MKV8KNSpecimen could not be analyzed Laboratory VACCINATION 1001V2_VAX2_L NO Non-Important2020-07-30ADVn YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NB@HqϼHrHqϼHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1001 10011104DV100111041001B@FWHITE DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA122773001IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-08-20BDV YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NB@HqϼHrHqϼHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1001 10011105DV100111051001BMWHITE DVoDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A122558801IP verification incomplete Investigational ProductVACCINATION 1001Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NBHqLHrHqLHr..Placebo Placebo .DW$ YC4591001C4591001 1001 10011107DV100111071001B4MWHITE DVoDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A122773201IP verification incomplete Investigational ProductVACCINATION 1001Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB4Hq Hr4Hq HrTHr_lHr4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011107DV100111071001B4MWHITE DVoDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1NRDXWFLab performed out of window Laboratory FOLLOW-UP 1001COVID_A NO Non-Important2020-09-22B6DV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB4Hq Hr4Hq HrTHr_lHr4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011107DV100111071001B4MWHITE DVoDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1NNYLENPotential COVID-19 illness visit not done when required per protocol. Visit Schedule FOLLOW-UP 1001POT_COVID_CONVA NO Non-Important2020-10-20BRDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB4Hq Hr4Hq HrTHr_lHr4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011108DV100111081001B9FBLACK OR AFRICAN AMERICAN DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 122774101IP verification incomplete Investigational ProductVACCINATION 1001Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB9Hq$HHr֤Hq$HHr 3Hr$Hr֤Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011108DV100111081001B9FBLACK OR AFRICAN AMERICAN DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1QW05YZLab performed out of window Laboratory VACCINATION 1001COVID_A NO Non-Important2020-09-03B#DV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB9Hq$HHr֤Hq$HHr 3Hr$Hr֤Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011108DV100111081001B9FBLACK OR AFRICAN AMERICAN DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA@1-1OT9E09Urine pregnancy test not performed. Laboratory FOLLOW-UP 1001V101_VAX3 NO Non-Important2020-09-23B7DV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB9Hq$HHr֤Hq$HHr 3Hr$Hr֤Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011108DV100111081001B9FBLACK OR AFRICAN AMERICAN DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA126351501IP documentation error - IRT Confirmation Report Error Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2020-12-22BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB9Hq$HHr֤Hq$HHr 3Hr$Hr֤Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011109DV100111091001BAMWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA122559101IP verification incomplete Investigational ProductVACCINATION 1001Vax 2 NO Non-Important2020-08-20BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBAHq/HrXHq/HrX..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011110DV100111101001BHMWHITE DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA0122774501IP verification incomplete Investigational ProductVACCINATION 1001Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBHHq'HrHq'HrHrslHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011110DV100111101001BHMWHITE DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 126358901IP documentation error - IRT Confirmation Report Error Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2020-12-24BDW YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBHHq'HrHq'HrHrslHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011110DV100111101001BHMWHITE DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA126359201IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductOPEN LABEL TREATMENT1001Vax 3 NO Non-Important2020-12-30BDW YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBHHq'HrHq'HrHrslHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011111DV100111111001B>MNOT REPORTED DVoDWAPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA122774901IP verification incomplete Investigational ProductVACCINATION 1001Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB>Hq3HsHq3Hr0Hr~`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011111DV100111111001B>MNOT REPORTED DVoDWAPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1N7E4Z7Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1001V2_VAX2_L NO Non-Important2020-08-24BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB>Hq3HsHq3Hr0Hr~`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011111DV100111111001B>MNOT REPORTED DVoDWAPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1OH0NVFVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1001COVID_B NO Non-Important2020-11-17BnDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB>Hq3HsHq3Hr0Hr~`HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011116DV100111161001B?MWHITE DVrDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 126352101IP documentation error - IRT Confirmation Report Error Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2020-12-23BDW YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB?HqHr֭HqHrHrHr֭Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011116DV100111161001B?MWHITE DVrDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA126359401IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductOPEN LABEL TREATMENT1001Vax 3 NO Non-Important2020-12-28BDW YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB?HqHr֭HqHrHrHr֭Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011119DV100111191001BJFASIAN DVrDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA126352701IP documentation error - IRT Confirmation Report Error Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2020-12-29BDW YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBJHq,HrpHq,Hr̼HruHrpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011121DV100111211001BBMWHITE DVsDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA126632501IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductFOLLOW-UP 1001Vax 3 NO Non-Important2021-01-06BDW YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBBHqDHrHqDHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1001 10011122DV100111221001BHFWHITE DVsDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1NRD49DPotential COVID-19 illness visit not done when required per protocol. Visit Schedule FOLLOW-UP 1001V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-06B@DV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBHHqJ,HrHqJ,Hr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW! YC4591001C4591001 1001 10011125DV100111251001BFWHITE DVsDVsBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NX8S4TVisit not done Visit Schedule VACCINATION 1001COVID_A1 NO Non-Important2020-08-26BDV YYPhase 3_ds6000 A0 . . .NA 18-55 YearsA 16-25 YearsNBHqhhHqhhHqhhHqhh..BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1001 10011126DV100111261001B0FWHITE DVsDW?Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NRZCGIVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1001POT_COVID_CONVA NO Non-Important2020-10-28BVDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB0HqjHHs4HqjHHrHrGHs4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1001 10011127DV100111271001BAMWHITE DVsDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA126353001IP documentation error - IRT Confirmation Report Error Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2020-12-18BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBAHq~Hr͠Hq~Hr HrHr͠Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011127DV100111271001BAMWHITE DVsDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 126632801Other IP deviation Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2020-12-21BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBAHq~Hr͠Hq~Hr HrHr͠Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011129DV100111291001B0MWHITE DVtDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NSJ9PFVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1001POT_COVID_CONVA NO Non-Important2020-09-23B2DV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB0HqDHrHqDHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011130DV100111301001B7MWHITE DVtDWDPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A127781201IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2021-02-07BDW. YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB7Hq(Hs Hq(HrBHrI4Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW* YC4591001C4591001 1001 10011131DV100111311001B*FWHITE DVtDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NRDXWALab performed out of window Laboratory VACCINATION 1001COVID_A NO Non-Important2020-09-27B6DV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB*Hq8Hr:Hq8Hr:..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011131DV100111311001B*FWHITE DVtDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NTSBCVVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1001POT_COVID_CONVA NO Non-Important2020-11-02BZDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB*Hq8Hr:Hq8Hr:..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011132DV100111321001B$MWHITE DVtDWDPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NRY4ZLPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1001POT_COVID_ILL NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB$HqHs üHqHr4HrqtHs üPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1001 10011134DV100111341001BHMWHITE DVtDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA126353301IP documentation error - IRT Confirmation Report Error Investigational ProductREPEAT SCREENING 1 1001Vax 3 NO Non-Important2020-12-18BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBHHqHrW8HqHrbHrrHHrW8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1001 10011135DV100111351001B-FWHITE DVtDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1RSWB89Visit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1001V102_VAX4 NO Non-Important2021-02-19BDW: YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB-HqHrHqHrtHr7XHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011137DV100111371001B>MWHITE DVuDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1MP7X2FParticipant randomized into incorrect age stratum in Impala Randomization VACCINATION 1001V1_DAY1_VAX1_L NO Non-Important2020-08-06ADVu YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB>HqHr0HqHr0..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1001 10011141DV100111411001BJMWHITE DVuDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA@1-1NUXWA0Potential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1001POT_COVID_ILL NO Non-Important2020-08-09A@DVx YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBJHqhHrHqhHr..Placebo Placebo .DW YC4591001C4591001 1001 10011141DV100111411001BJMWHITE DVuDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1NFPBRANasal swab not collected for the visit where it is required Laboratory VACCINATION 1001POT_COVID_ILL NO Non-Important2020-09-09B#DV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBJHqhHrHqhHr..Placebo Placebo .DW YC4591001C4591001 1001 10011141DV100111411001BJMWHITE DVuDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1NML51RNasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1001POT_COVID_ILL NO Non-Important2020-09-25B3DV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBJHqhHrHqhHr..Placebo Placebo .DW YC4591001C4591001 1001 10011141DV100111411001BJMWHITE DVuDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APAP1-1NVMGJ9Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1001POT_COVID_ILL NO Non-Important2020-09-25B3DV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBJHqhHrHqhHr..Placebo Placebo .DW YC4591001C4591001 1001 10011141DV100111411001BJMWHITE DVuDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1NV5MM7Lab performed out of window Laboratory FOLLOW-UP 1001POT_COVID_ILL NO Non-Important2020-11-03BZDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBJHqhHrHqhHr..Placebo Placebo .DW YC4591001C4591001 1001 10011145DV100111451001BFBLACK OR AFRICAN AMERICAN DVvDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OUFGG2Nasal swab not collected for the visit where it is required Laboratory OPEN LABEL TREATMENT1001V102_VAX4 NO Non-Important2021-01-26BDW" YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NBHqTHrާHqTHrHrŝHrާPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1001 10011149DV100111491001B"FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NSJ9PIVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1001POT_COVID_CONVA NO Non-Important2020-09-24B1DV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB"Hqs,HrHqs,Hr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1002 10021001DV100210011002B-FWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1JNZDT7Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-29.DV NNPhase 1 A . . .NA 18-55 Years. NB-...... .. NC4591001C4591001 1002 10021002DV100210021002B(FASIAN ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1JNZDTBProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-29.DV NNPhase 1 A . . .NA 18-55 Years. NB(...... .. NC4591001C4591001 1002 10021003DV100210031002BMWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JNZDTEProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-29PDVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqDHqHqDHq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021004DV100210041002BFWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JNZDTHProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-29PDVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqHqHq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021005DV100210051002B6MWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1JNZDTKProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-29PDVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB6HqHr֩HqHq<Hr@Hr֩Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021005DV100210051002B6MWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1OOQTY5Procedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB6HqHr֩HqHq<Hr@Hr֩Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021006DV100210061002B)FWHITE DVDV4BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A 1-1JNZDTNProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-30DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB)Hq0Hq" Hq0Hq" ..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021007DV100210071002BMWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JNZDTQProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-30`DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqHqHq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021008DV100210081002B MASIAN DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1JNZDTTProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-30`DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB Hq8HqHq8Hq..Placebo Placebo .DV YC4591001C4591001 1002 10021008DV100210081002B MASIAN DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1T5A5LZBlind broken outside of IRT when not permitted per protocol Procedures/Tests REPEAT SCREENING 1 1002V3_WEEK1_POSTVAX1_S NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB Hq8HqHq8Hq..Placebo Placebo .DV YC4591001C4591001 1002 10021008DV100210081002B MASIAN DVDV-Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A01-1OV4AUIUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests REPEAT SCREENING 1 1002Unplanned NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =Placebo A`Placebo A`NA 18-55 Years. NB Hq8HqHq8Hq..Placebo Placebo .DV YC4591001C4591001 1002 10021009DV100210091002BFASIAN DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JNZDTWProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-30`DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqxHqHHqxHqH..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021009DV100210091002BFASIAN DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A 1-1KVD4LIVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1002V7_MONTH1_S NO Non-Important2020-07-02B:DVR YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqxHqHHqxHqH..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021010DV100210101002BMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1JNZDTZProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-30.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1002 10021011DV100210111002B%MWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JNZDU2Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-30`DVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB%Hq0Hq\Hq0Hq\..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021011DV100210111002B%MWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A 1-1KCUQOCVisit not done Visit Schedule VACCINATION 1002Unscheduled Telehealth Visit NO Non-Important2020-05-08A0DV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB%Hq0Hq\Hq0Hq\..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021012DV100210121002BFWHITE DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JNZDU5Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-04-30PDVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq"Hq,Hq"Hq,..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021013DV100210131002BFASIAN DVDV-BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA18-55 YearsA0A1-1JNZDU8Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-01PDVYNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) A=p =10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq,HqLHq,HqL..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021014DV100210141002B&FWHITE DV DV4BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A 1-1JNZDUBProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-01DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB&HqHq`HqHq`..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021015DV100210151002B0FWHITE DVDV4BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0AP1-1JNZDUEProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-01DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB0Hq,$HqHq,$Hq..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021015DV100210151002B0FWHITE DVDV4BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A@1-1JNZDUWUrine pregnancy test not performed. Laboratory VACCINATION 1002V1_DAY1_VAX1_S NO Non-Important2020-05-11ADV YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB0Hq,$HqHq,$Hq..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021015DV100210151002B0FWHITE DVDV4BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A01-1JVA4NESpecimen could not be analyzed Laboratory VACCINATION 1002V2_DAY2_POSTVAX1_S NO Non-Important2020-05-12A DV YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB0Hq,$HqHq,$Hq..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021015DV100210151002B0FWHITE DVDV4BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A1-1KUAYSAOther Informed Consent Informed Consent FOLLOW-UP 1002Consent NO Non-Important2020-07-01B4DVQ YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB0Hq,$HqHq,$Hq..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021016DV100210161002B3MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JNZDUHProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-01.DV NNPhase 1 A . . .NA 18-55 Years. NB3...... .. NC4591001C4591001 1002 10021017DV100210171002B#FWHITE DV DV4BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A 1-1JNZDUKProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-01DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB#HqHHq @HqHHq @..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021018DV100210181002B3FWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1JD6JBXOther Informed Consent Informed Consent SCREENING 1002Consent NO Non-Important2020-05-01DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) AffffffPlacebo A`Placebo A`NA 18-55 Years. NB3Hq.|Hr֨hHq.|Hq3HrHr֨hPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021018DV100210181002B3FWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1JNZDUNProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-01DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) AffffffPlacebo A`Placebo A`NA 18-55 Years. NB3Hq.|Hr֨hHq.|Hq3HrHr֨hPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021019DV100210191002B6MBLACK OR AFRICAN AMERICAN ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JNZDUQProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-01.DV NNPhase 1 A . . .NA 18-55 Years. NB6...... .. NC4591001C4591001 1002 10021020DV100210201002BFWHITE DV DV4BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) B1_30 BNT162b1 Phase 1 (30 mcg) BNT162b1 Phase 1 (30 mcg) A0A018-55 YearsA0A 1-1JNZDUTProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-01DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) Affffff30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NBHqHq1 HqHq1 ..BNT162b1 (30 (*ESC*){unicode 03BC}g) BNT162b1 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021021DV100210211002B,MWHITE DV DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1JOVBFZProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-04DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) AffffffPlacebo A`Placebo A`NA 18-55 Years. NB,HqHrn4HqHq+HriHrn4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021021DV100210211002B,MWHITE DV DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1OOQTY9Procedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) AffffffPlacebo A`Placebo A`NA 18-55 Years. NB,HqHrn4HqHq+HriHrn4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021022DV100210221002B!MWHITE DV DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1JOVBG4Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-04DVYNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) AffffffPlacebo A`Placebo A`NA 18-55 Years. NB!Hq0Hr֦Hq0Hq)(Hr(Hr֦Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021022DV100210221002B!MWHITE DV DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1OOQTYCProcedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) AffffffPlacebo A`Placebo A`NA 18-55 Years. NB!Hq0Hr֦Hq0Hq)(Hr(Hr֦Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021023DV100210231002BFWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A@1-1JOVBG7Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-05DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHqitHr ]DHqitHr ]D..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021023DV100210231002BFWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1KCUQO3Other IP deviation Investigational ProductVACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHqitHr ]DHqitHr ]D..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021023DV100210231002BFWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KCUQLGNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHqitHr ]DHqitHr ]D..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021023DV100210231002BFWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1KCUQLCUrine pregnancy test not performed. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHqitHr ]DHqitHr ]D..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021023DV100210231002BFWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0AP1-1NVMGJDVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1002POT_COVID_CONVA NO Non-Important2020-11-09BDV YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHqitHr ]DHqitHr ]D..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021024DV100210241002B-FWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1JDDZ9COther Informed Consent Informed Consent SCREENING 1002Consent NO Non-Important2020-05-05DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB-HqgHrѐHqgHrѐ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021024DV100210241002B-FWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0AP1-1JOVBHOProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-05DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB-HqgHrѐHqgHrѐ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021024DV100210241002B-FWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KFEJC5Other IP deviation Investigational ProductVACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB-HqgHrѐHqgHrѐ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021024DV100210241002B-FWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1KFEJCBNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB-HqgHrѐHqgHrѐ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021024DV100210241002B-FWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A@1-1KFEJBPUrine pregnancy test not performed. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-10BDV< YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB-HqgHrѐHqgHrѐ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021025DV100210251002B"MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBHRProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-05.DV NNPhase 1 A . . .NA 18-55 Years. NB"...... .. NC4591001C4591001 1002 10021026DV100210261002B.MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBHVProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-05.DV NNPhase 1 A . . .NA 18-55 Years. NB....... .. NC4591001C4591001 1002 10021027DV100210271002BMWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1JOVBIIProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-05DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHqcHr e<HqcHr e<..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021027DV100210271002BMWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1KFEJCKOther IP deviation Investigational ProductVACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHqcHr e<HqcHr e<..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021027DV100210271002BMWHITE DV%DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KFEJCNNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-08BDV: YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NBHqcHr e<HqcHr e<..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021028DV100210281002BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBILProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-05.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1002 10021029DV100210291002B+FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBIOProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB+...... .. NC4591001C4591001 1002 10021030DV100210301002B'MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBIRProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB'...... .. NC4591001C4591001 1002 10021031DV100210311002B1MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBIUProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB1...... .. NC4591001C4591001 1002 10021032DV100210321002B-MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBIXProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB-...... .. NC4591001C4591001 1002 10021033DV100210331002B,FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBJ0Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB,...... .. NC4591001C4591001 1002 10021034DV100210341002B!MWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1JOVBJ3Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-07DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB!HqXTHr a@HqXTHr a@..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021034DV100210341002B!MWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1KFEJCXOther IP deviation Investigational ProductVACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB!HqXTHr a@HqXTHr a@..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021034DV100210341002B!MWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KFEJD0Nasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB!HqXTHr a@HqXTHr a@..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021035DV100210351002B*MWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1JOVBJ6Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-07DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB*HqShHr HqShHr ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021035DV100210351002B*MWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1KFEJCUOther IP deviation Investigational ProductVACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB*HqShHr HqShHr ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021035DV100210351002B*MWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KFEJCRNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB*HqShHr HqShHr ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021036DV100210361002B*FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0AP1-1JOVBJ9Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-07DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB*Hq[$Hr Hq[$Hr ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021036DV100210361002B*FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KED61TOther IP deviation Investigational ProductVACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-11BDV= YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB*Hq[$Hr Hq[$Hr ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021036DV100210361002B*FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1KED61QNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-11BDV= YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB*Hq[$Hr Hq[$Hr ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021036DV100210361002B*FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A@1-1KED61LUrine pregnancy test not performed. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-11BDV= YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB*Hq[$Hr Hq[$Hr ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021036DV100210361002B*FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1NSGDFHSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsFOLLOW-UP 1002V4_WEEK3_VAX2_S NO Non-Important2020-08-24B`DV YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB*Hq[$Hr Hq[$Hr ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021037DV100210371002B3MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBK6Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-07.DV NNPhase 1 A . . .NA 18-55 Years. NB3...... .. NC4591001C4591001 1002 10021038DV100210381002B5FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A01-1NGVYP1Urine pregnancy test not performed. Laboratory SCREENING 1002SCR NO Non-Important2020-05-07DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5HqbHr c HqbHr c ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021038DV100210381002B5FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0AP1-1JOVBK9Procedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-07DVYNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5HqbHr c HqbHr c ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021038DV100210381002B5FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A1-1KFEJC8Other IP deviation Investigational ProductVACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5HqbHr c HqbHr c ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021038DV100210381002B5FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A 1-1KFEJCENasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5HqbHr c HqbHr c ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021038DV100210381002B5FWHITE DV(DVBNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)B1_100 BNT162b1 Phase 1 (100/10 mcg)BNT162b1 Phase 1 (100/10 mcg)A@A@18-55 YearsA0A@1-1KFEJBSUrine pregnancy test not performed. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAP100 (*ESC*){unicode 03BC}g/10 (*ESC*){unicode 03BC}gAPNA 18-55 Years. NB5HqbHr c HqbHr c ..BNT162b1 (100 (*ESC*){unicode 03BC}g)BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021039DV100210391002B1MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOVBKCProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-07.DV NNPhase 1 A . . .NA 18-55 Years. NB1...... .. NC4591001C4591001 1002 10021040DV100210401002B4FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1JOXBGHProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-07.DV NNPhase 1 A . . .NA 18-55 Years. NB4...... .. NC4591001C4591001 1002 10021041DV100210411002B.MWHITE DV(DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A01-1JRSD4QProcedure/Test not done Procedures/Tests SCREENING 1002SCR NO Non-Important2020-05-180DV%YNYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NB.HqV8HrkHqV8Hr gHr5HrkPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021041DV100210411002B.MWHITE DV(DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1KCUQO6Other IP deviation Investigational ProductVACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NB.HqV8HrkHqV8Hr gHr5HrkPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021041DV100210411002B.MWHITE DV(DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1KCUQO9Nasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1002V4_WEEK3_VAX2_S NO Non-Important2020-06-09BDV; YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NB.HqV8HrkHqV8Hr gHr5HrkPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021041DV100210411002B.MWHITE DV(DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A@1-1OOQTZJProcedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NB.HqV8HrkHqV8Hr gHr5HrkPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021041DV100210411002B.MWHITE DV(DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0AP1-1QVAOT6Visit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1002V102_VAX4 NO Non-Important2021-02-03C0DW* YYPhase 1 AStage 1, Age 18 to 55, High dose level (100mcg), 21 Day (BNT162b1 or PBO) A\(Placebo A`Placebo A`NA 18-55 Years. NB.HqV8HrkHqV8Hr gHr5HrkPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021042DV100210421002BAFWHITE DV;DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1OOQTZPProcedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =qPlacebo A`Placebo A`NA0>55 Years . NBAHqcHr֘HqcHq HrHr֘Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021043DV100210431002BCMWHITE DV;DVPBNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA65-85 YearsA@A1-1KTFYIGOther Informed Consent Informed Consent VACCINATION 1002Consent NO Non-Important2020-06-30BDVP YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =q10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBCHq^HqHq^Hq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021047DV100210471002BAFWHITE DV=DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1OOQTZMProcedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =qPlacebo A`Placebo A`NA0>55 Years . NBAHqHr֙hHqHqhHrHHr֙hPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021049DV100210491002BRFWHITE DV=DVPBNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA65-85 YearsA@A1-1LGBR23Procedure/Test not performed per protocol Procedures/Tests SCREENING 1002SCR NO Non-Important2020-06-01DV3YNYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =q10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBRHqHq#THqHq#T..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021050DV100210501002BDFWHITE DVADW"Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1OOQTZSProcedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQPlacebo A`Placebo A`NA0>55 Years . NBDHqAHrHqAHqSHr2<HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021053DV100210531002BFFWHITE DV=DVPBNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) B1_10 BNT162b1 Phase 1 (10 mcg) BNT162b1 Phase 1 (10 mcg) AA65-85 YearsA@A1-1KXHXSVParticipant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a >=grade 1 abnormality) Inclusion/Exclusion VACCINATION 1002V1_DAY1_VAX1_S YES-POP2,YES-POP3 Important 2020-06-11ADV= YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b1 or PBO) Ap =q10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBFHq`HqHq`Hq..BNT162b1 (10 (*ESC*){unicode 03BC}g) BNT162b1 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021060DV100210601002BQMWHITE DVADVWBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 65-85 YearsA@A1-1OS02M2Other Informed Consent Informed Consent REPEAT SCREENING 1 1002Consent NO Non-Important2021-01-06BDW YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQ20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBQHqDtHqPHqDtHqP..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021071DV100210711002BGFWHITE DVCDVXBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 65-85 YearsA@A1-1NZLLYPPotential COVID-19 illness visit not done when required per protocol. Visit Schedule FOLLOW-UP 1002POT_COVID_ILL NO Non-Important2020-09-17B]DV YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQ20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBGHqHqըHqHqը..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021072DV100210721002BAFWHITE DVDDW"Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1OOQTZVProcedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b1 or PBO) APlacebo A`Placebo A`NA0>55 Years . NBAHqRDHr(HqRDHqձHr3Hr(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021073DV100210731002BIFWHITE DVCDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1OOQTZYProcedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQPlacebo A`Placebo A`NA0>55 Years . NBIHqHrmHqHqզHrkHrmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021081DV100210811002B"MWHITE DVQDVeBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 18-55 YearsA0A1-1LGBR27Procedure/Test not performed per protocol Procedures/Tests SCREENING 1002SCR NO Non-Important2020-06-22DVHYNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQR20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB#HqkHqҘHqkHqҘ..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021082DV100210821002B6FWHITE DVQDVeBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 18-55 YearsA0A1-1NV89DOUrine pregnancy test not performed. Laboratory SCREENING 1002V1_DAY1_VAX1_S NO Non-Important2020-06-22DVHYNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQR20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB6HqqHqHqqHq..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021082DV100210821002B6FWHITE DVQDVeBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 18-55 YearsA0A 1-1LGBR2AProcedure/Test not performed per protocol Procedures/Tests SCREENING 1002SCR NO Non-Important2020-06-22DVHYNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQR20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB6HqqHqHqqHq..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021082DV100210821002B6FWHITE DVQDVeBNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) B1_20 BNT162b1 Phase 1 (20 mcg) BNT162b1 Phase 1 (20 mcg) A A 18-55 YearsA0A01-1NZLLYSPotential COVID-19 illness visit not done when required per protocol. Visit Schedule FOLLOW-UP 1002POT_COVID_ILL NO Non-Important2020-08-25B8DV YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQR20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB6HqqHqHqqHq..BNT162b1 (20 (*ESC*){unicode 03BC}g) BNT162b1 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1002 10021083DV100210831002BMWHITE DVQDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1OOQU01Procedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1002Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b1 or PBO)AQRPlacebo A`Placebo A`NA 18-55 Years. NBHqslHrj8HqslHq̼Hrh Hrj8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031001DV100310011003BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSP9NProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031002DV100310021003BFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSP9RProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031003DV100310031003B5FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSP9UProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB5...... .. NC4591001C4591001 1003 10031004DV100310041003BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPB1Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031005DV100310051003B1FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPB4Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB1...... .. NC4591001C4591001 1003 10031006DV100310061003BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPB7Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031007DV100310071003BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPBAProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031008DV100310081003BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPBDProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-05.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031009DV100310091003B#MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPBGProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-05.DV NNPhase 1 A . . .NA 18-55 Years. NB#...... .. NC4591001C4591001 1003 10031010DV100310101003BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPBJProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-05.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031011DV100310111003B*FWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KPSPBMProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB*...... .. NC4591001C4591001 1003 10031012DV100310121003BMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KPSPBPProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031013DV100310131003B(FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPBSProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB(...... .. NC4591001C4591001 1003 10031014DV100310141003B4MWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPBVProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB4...... .. NC4591001C4591001 1003 10031015DV100310151003B0MMULTIPLE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KPSPBYProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB0...... .. NC4591001C4591001 1003 10031016DV100310161003BMWHITE DV;DW"Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1KPSPC1Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-01DV3YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQPlacebo A`Placebo A`NA 18-55 Years. NBHqiHr0HqiHq PHrHr0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031016DV100310161003BMWHITE DV;DW"Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1L959MFRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-03B8DVr YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQPlacebo A`Placebo A`NA 18-55 Years. NBHqiHr0HqiHq PHrHr0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031016DV100310161003BMWHITE DV;DW"Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A01-1OEKRSEVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003V8_MONTH6_S NO Non-Important2020-12-08BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQPlacebo A`Placebo A`NA 18-55 Years. NBHqiHr0HqiHq PHrHr0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031017DV100310171003B4MWHITE DV=DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1KPSPC4Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-01DV3YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQPlacebo A`Placebo A`NA 18-55 Years. NB4Hq HrHq HqͯHrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031017DV100310171003B4MWHITE DV=DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1KVKRBLParticipant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a >=grade 1 abnormality) Inclusion/Exclusion VACCINATION 1003Visit 1 YES-POP2,YES-POP3 Important 2020-06-11ADV= YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQPlacebo A`Placebo A`NA 18-55 Years. NB4Hq HrHq HqͯHrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031018DV100310181003B5FWHITE DV;DVPBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KPSPDLProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-01DV3YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB5HqhHq`HqhHq`..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031018DV100310181003B5FWHITE DV;DVPBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1O80WFWRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-29B3DVm YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB5HqhHq`HqhHq`..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031018DV100310181003B5FWHITE DV;DVPBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A01-1OEKRTVVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003V8_MONTH6_S NO Non-Important2020-12-08BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB5HqhHq`HqhHq`..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031019DV100310191003B1FWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KPSPDOProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-01DV3YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB1Hq ,HqͭHq ,Hqͭ..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031019DV100310191003B1FWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1QW0Q9DRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent REPEAT SCREENING 1 1003Consent NO Non-Important2020-12-29BDW YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB1Hq ,HqͭHq ,Hqͭ..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031020DV100310201003B(FWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KPSPDRProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-01DV3YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB(HqlHqͰHqlHqͰ..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031020DV100310201003B(FWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1KVJN4XProcedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1 NO Non-Important2020-06-11ADV= YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB(HqlHqͰHqlHqͰ..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031021DV100310211003BMWHITE DV;DVPBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1KQNBFCParticipant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a >=grade 1 abnormality) Inclusion/Exclusion SCREENING 1003V1 YES-POP2,YES-POP3 Important 2020-06-02pDV4YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqiHHqHqiHHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031021DV100310211003BMWHITE DV;DVPBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KQDNTXProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-02pDV4YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqiHHqHqiHHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031021DV100310211003BMWHITE DV;DVPBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A01-1OEKRTYVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003V8_MONTH6_S NO Non-Important2020-12-07BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqiHHqHqiHHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031022DV100310221003BMWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A01-1KQDNU0Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-03DV5YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq xHqͭ@Hq xHqͭ@..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031022DV100310221003BMWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KQNBG2Procedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1 NO Non-Important2020-06-11ADV= YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq xHqͭ@Hq xHqͭ@..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031022DV100310221003BMWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1PM8UGTRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent REPEAT SCREENING 1 1003Consent NO Non-Important2021-01-04BDW YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq xHqͭ@Hq xHqͭ@..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031023DV100310231003BFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KK5W9PSubject/LAR signed a superseded/outdated version of the ICD Informed Consent SCREENING 1003Consent NO Non-Important2020-06-03.DV5 NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031023DV100310231003BFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A 1-1KQDNUDProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-03.DV5 NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031024DV100310241003B#MWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KQDNUGProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-03DV5YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB#HqLHqͮlHqLHqͮl..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031024DV100310241003B#MWHITE DV=DVRBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1QW0QBHRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent REPEAT SCREENING 1 1003Consent NO Non-Important2020-12-30BDW YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB#HqLHqͮlHqLHqͮl..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031025DV100310251003B,FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A 1-1KQDNUJProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-03.DV5 NNPhase 1 A . . .NA 18-55 Years. NB,...... .. NC4591001C4591001 1003 10031025DV100310251003B,FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KK5WAFSubject/LAR signed a superseded/outdated version of the ICD Informed Consent SCREENING 1003Consent NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA 18-55 Years. NB,...... .. NC4591001C4591001 1003 10031026DV100310261003BMWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1KQDNUMProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NBHq8HqՌhHq8HqՌh..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031026DV100310261003BMWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1QW0ZBZRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent REPEAT SCREENING 1 1003Consent NO Non-Important2021-01-04BDW YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NBHq8HqՌhHq8HqՌh..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031027DV100310271003B0MBLACK OR AFRICAN AMERICAN DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1KQDNUZProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB0HqBHqHqBHq..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031027DV100310271003B0MBLACK OR AFRICAN AMERICAN DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1L95G3ORevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-04B3DVs YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB0HqBHqHqBHq..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031028DV100310281003BMWHITE DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1KQDNV2Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-04DV6YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NBHqCHq<HqCHq<..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031028DV100310281003BMWHITE DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1QW0ZCZRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent REPEAT SCREENING 1 1003Consent NO Non-Important2020-12-29BDW YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NBHqCHq<HqCHq<..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031029DV100310291003BFWHITE DVADWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1KQDNV5Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-04DV6YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NBHqEHrHqEHqHrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031029DV100310291003BFWHITE DVADWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1QW0QFJRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent OPEN LABEL TREATMENT1003Consent NO Non-Important2020-12-31BDW YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NBHqEHrHqEHqHrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031030DV100310301003B"FWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1KQDNV8Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB"HqHqՏHqHqՏ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031030DV100310301003B"FWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1KVJN55Procedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1 NO Non-Important2020-06-17ADVC YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB"HqHqՏHqHqՏ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031031DV100310311003BIFWHITE DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A1-1KQDNVBProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBIHqmHqpHqmHqp..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031032DV100310321003B%FWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1KL2NCNSubject/LAR signed a superseded/outdated version of the ICD Informed Consent SCREENING 1003Consent NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB%HqHqՏ8HqHqՏ8..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031032DV100310321003B%FWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A@1-1KQDNVEProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB%HqHqՏ8HqHqՏ8..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031032DV100310321003B%FWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1L95G3URevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-05B2DVt YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB%HqHqՏ8HqHqՏ8..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031032DV100310321003B%FWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A01-1R2MTAFUrine pregnancy test not performed. Laboratory FOLLOW-UP 1003V8A_VAX3 NO Non-Important2020-08-10B7DVy YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB%HqHqՏ8HqHqՏ8..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031033DV100310331003BHFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQDNVHProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBH...... .. NC4591001C4591001 1003 10031034DV100310341003B,FWHITE DVCDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1KL2NIJSubject/LAR signed a superseded/outdated version of the ICD Informed Consent SCREENING 1003Consent NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NB,HqdHrHqdHqՍHr0HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031034DV100310341003B,FWHITE DVCDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A@1-1KQDNVKProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NB,HqdHrHqdHqՍHr0HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031034DV100310341003B,FWHITE DVCDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A01-1KVJN51Procedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1 NO Non-Important2020-06-17ADVC YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NB,HqdHrHqdHqՍHr0HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031034DV100310341003B,FWHITE DVCDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 126973301IP documentation error IRT Confirmation Report error Investigational ProductOPEN LABEL TREATMENT1003Vax 4 NO Non-Important2021-01-24BDW YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NB,HqdHrHqdHqՍHr0HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031035DV100310351003BEFWHITE DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A1-1KQDNVNProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBEHqk Hq`Hqk Hq`..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031036DV100310361003BCMWHITE DVADW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1KQEW19Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA0>55 Years . NBCHqlHr8HqlHqHrPHr8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031037DV100310371003BFMWHITE DVBDVWBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A1-1KQEW1CProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBFHq4Hq? Hq4Hq? ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031038DV100310381003B4MWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1KE4LE3Subject/LAR signed a superseded/outdated version of the ICD Informed Consent SCREENING 1003Consent NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB4HqHqՎHHqHqՎH..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031038DV100310381003B4MWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1KQEW1FProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB4HqHqՎHHqHqՎH..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031039DV100310391003BLMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW1IProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBL...... .. NC4591001C4591001 1003 10031040DV100310401003BIFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KCO8NNSubject/LAR signed a superseded/outdated version of the ICD Informed Consent SCREENING 1003Consent NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBI...... .. NC4591001C4591001 1003 10031040DV100310401003BIFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A 1-1KQEW1LProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBI...... .. NC4591001C4591001 1003 10031041DV100310411003BCFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW1OProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBC...... .. NC4591001C4591001 1003 10031042DV100310421003BRMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW1RProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBR...... .. NC4591001C4591001 1003 10031043DV100310431003BDFWHITE DVBDW%Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A 1-1KE4LH1Subject/LAR signed a superseded/outdated version of the ICD Informed Consent SCREENING 1003Consent NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBDHq|HrHq|Hq>lHr'pHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031043DV100310431003BDFWHITE DVBDW%Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@AP1-1KQEW1UProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBDHq|HrHq|Hq>lHr'pHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031043DV100310431003BDFWHITE DVBDW%Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1O849F7Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-06B4DVu YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBDHq|HrHq|Hq>lHr'pHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031043DV100310431003BDFWHITE DVBDW%Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A@1-1LYAXVLSerology sample not collected Laboratory FOLLOW-UP 1003Visit 7 NO Non-Important2020-08-06B4DVu YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBDHq|HrHq|Hq>lHr'pHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031043DV100310431003BDFWHITE DVBDW%Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A0126713001IP documentation error IP preparation form errors Investigational ProductREPEAT SCREENING 1 1003Vax 3 NO Non-Important2021-01-07BDW YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBDHq|HrHq|Hq>lHr'pHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031044DV100310441003BBMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW1XProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBB...... .. NC4591001C4591001 1003 10031045DV100310451003BAFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..65-85 YearsA@A1-1KQEW20Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05.DV7 NNPhase 1 A . . .NA0>55 Years . NBA...... .. NC4591001C4591001 1003 10031046DV100310461003BJFWHITE DVDDW"Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1KQEW41Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-05DV7YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBJHqW0HrDHqW0HqHr4HrDPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031046DV100310461003BJFWHITE DVDDW"Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A 1-1R2K4SZVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL FOLLOW-UP1003V8_MONTH6_S NO Non-Important2021-02-22BDW= YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBJHqW0HrDHqW0HqHr4HrDPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031047DV100310471003BEFWHITE DVBDVWBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A1-1KQNBFZParticipant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a >=grade 1 abnormality) Inclusion/Exclusion SCREENING 1003V1 YES-POP2,YES-POP3 Important 2020-06-08DV:YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBEHqHq?HqHq?..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031047DV100310471003BEFWHITE DVBDVWBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A01-1KQEW44Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-08DV:YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBEHqHq?HqHq?..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031047DV100310471003BEFWHITE DVBDVWBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A 1-1KQNBG5Procedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1 NO Non-Important2020-06-16ADVB YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBEHqHq?HqHq?..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031048DV100310481003BIMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW47Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-08.DV: NNPhase 1 A . . .NA0>55 Years . NBI...... .. NC4591001C4591001 1003 10031049DV100310491003BFMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW4KProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-08.DV: NNPhase 1 A . . .NA0>55 Years . NBF...... .. NC4591001C4591001 1003 10031050DV100310501003B)MWHITE DVHDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1KQEW4NProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-08DV:YNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGzPlacebo A`Placebo A`NA 18-55 Years. NB)Hq{HrtxHq{Hq"DHrTHrtxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031051DV100310511003BAMWHITE DVDDVYBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A1-1KQEW4QProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-08DV:YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBAHqX HqHqX Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031051DV100310511003BAMWHITE DVDDVYBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A 1-1OSVPAOVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1003V8_MONTH6_S NO Non-Important2020-12-29BDW YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBAHqX HqHqX Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031052DV100310521003BAFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW4TProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-08.DV: NNPhase 1 A . . .NA0>55 Years . NBA...... .. NC4591001C4591001 1003 10031053DV100310531003BQFWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A1-1KQEW4WProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-09DV;YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBQHqHqոHqHqո..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031054DV100310541003BBFWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A 1-1KQEW4ZProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-10pDV<YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBBHqHqպHqHqպ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031054DV100310541003BBFWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A1-1L95G4KRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-05B2DVt YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBBHqHqպHqHqպ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031055DV100310551003BCFWHITE DVCDVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A1-1KQEW52Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-10pDV<YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBCHqHqlHqHql..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031056DV100310561003BGMWHITE DVDDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A 1-1KQEW5FProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-10DV<YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBGHqUHrހHqUHqpHr HrހPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031056DV100310561003BGMWHITE DVDDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1O849KXRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-06B2DVu YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzGPlacebo A`Placebo A`NA0>55 Years . NBGHqUHrހHqUHqpHr HrހPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031057DV100310571003B#FASIAN DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A@1-1KQEW5IProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-10DV<YNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB#Hq/HqȌHq/HqȌ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031057DV100310571003B#FASIAN DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A1-1L7TN4ERevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-29B$DVm YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB#Hq/HqȌHq/HqȌ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031057DV100310571003B#FASIAN DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A 1-1O15KCMLab performed out of window Laboratory FOLLOW-UP 1003COVID_A NO Non-Important2020-08-22B<DV YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB#Hq/HqȌHq/HqȌ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031057DV100310571003B#FASIAN DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A01-1NRDXW7Lab performed out of window Laboratory FOLLOW-UP 1003POT_COVID_ILL NO Non-Important2020-08-24B>DV YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB#Hq/HqȌHq/HqȌ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031057DV100310571003B#FASIAN DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0AP1-1NRVLPIVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003POT_COVID_CONVA NO Non-Important2020-10-27B~DV YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB#Hq/HqȌHq/HqȌ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031058DV100310581003BJFWHITE DVDDVYBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A 1-1KQEW5LProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-10DV<YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBJHqT$HqHqT$Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031058DV100310581003BJFWHITE DVDDVYBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A1-1O849SVRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-06B2DVu YYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBJHqT$HqHqT$Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031059DV100310591003B6MWHITE DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A01-1KQEW5OProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-10DV<YNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB6Hq-4Hq4Hq-4Hq4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031059DV100310591003B6MWHITE DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A 1-1KYLHW1Procedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003Visit 1 NO Non-Important2020-06-24ADVJ YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB6Hq-4Hq4Hq-4Hq4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031059DV100310591003B6MWHITE DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A1-1O84A09Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-29B$DVm YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB6Hq-4Hq4Hq-4Hq4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031060DV100310601003BDFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW5RProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-12.DV> NNPhase 1 A . . .NA0>55 Years . NBD...... .. NC4591001C4591001 1003 10031061DV100310611003BFWHITE DVHDV]BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A 1-1KQEW5UProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-12DV>YNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NBHq}Hq#Hq}Hq#..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031061DV100310611003BFWHITE DVHDV]BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A1-1L7TANWRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-27B$DVk YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NBHq}Hq#Hq}Hq#..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031062DV100310621003BMNOT REPORTED ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KQEW6HProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-12.DV> NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1003 10031063DV100310631003BAFWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A 1-1KQEW6KProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-12PDV>YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBAHqHqջHqHqջ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031063DV100310631003BAFWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A1-1O84A0PRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-05B2DVt YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBAHqHqջHqHqջ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031063DV100310631003BAFWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A01-1QVJ86XVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003V8_MONTH6_S NO Non-Important2020-12-09BDV YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBAHqHqջHqHqջ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031064DV100310641003BFMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KQEW6NProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-12.DV> NNPhase 1 A . . .NA0>55 Years . NBF...... .. NC4591001C4591001 1003 10031065DV100310651003B4FWHITE DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A01-1KQEW6QProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-12DV>YNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB4Hq10HqHq10Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031065DV100310651003B4FWHITE DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A 1-1KYHXZ6Procedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1_DAY1_VAX1_S NO Non-Important2020-06-24ADVJ YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB4Hq10HqHq10Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031065DV100310651003B4FWHITE DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A1-1L7TANQRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-29B$DVm YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB4Hq10HqHq10Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031065DV100310651003B4FWHITE DVJDV_BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A@1-1NYJ2N8SAE report delayed or not reported to Sponsor Safety Reporting FOLLOW-UP 1003V8_MONTH6_S NO Non-Important2020-11-12BDV YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB4Hq10HqHq10Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031066DV100310661003B,FWHITE DVHDV]BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A 1-1KQEW73Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-12DV>YNYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB,HqHq#4HqHq#4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031066DV100310661003B,FWHITE DVHDV]BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A1-1L7SS6KRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-27B$DVk YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB,HqHq#4HqHq#4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031067DV100310671003BHMWHITE DVCDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1O84A1ZRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-08-06B3DVu YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA0>55 Years . NBHHq|Hr֩Hq|HqչHrFHr֩Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031070DV100310701003B5MWHITE DVJDW%Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1KQNBGLParticipant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a >=grade 1 abnormality) Inclusion/Exclusion VACCINATION 1003V1 YES-POP2,YES-POP3 Important 2020-06-24ADVJ YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGzPlacebo A`Placebo A`NA 18-55 Years. NB5Hq0|HrHq0|HqHraHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031070DV100310701003B5MWHITE DVJDW%Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 1-1L5IFVDRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-27B"DVk YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGzPlacebo A`Placebo A`NA 18-55 Years. NB5Hq0|HrHq0|HqHraHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031070DV100310701003B5MWHITE DVJDW%Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A0126713201IP documentation error IP preparation form errors Investigational ProductFOLLOW-UP 1003Vax 3 NO Non-Important2021-01-07BDW YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGzPlacebo A`Placebo A`NA 18-55 Years. NB5Hq0|HrHq0|HqHraHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031072DV100310721003B&FWHITE DVJDV`BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp18-55 YearsA0A1-1L95G50Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-30B%DVn YYPhase 1 AStage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AGz30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA 18-55 Years. NB&Hq.$HqHq.$Hq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031076DV100310761003BGMWHITE DVODVdBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A 1-1LGCS47Procedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-23`DVIYNYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBGHqɹHq\HqɹHq\..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031076DV100310761003BGMWHITE DVODVdBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A1-1L4E2LURevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-27BDVk YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBGHqɹHq\HqɹHq\..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031077DV100310771003BCFWHITE DVQDVfBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A 1-1LGN4ACProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-23DVIYNYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBCHqcHqHqcHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031077DV100310771003BCFWHITE DVQDVfBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A1-1L7RQC0Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-29BDVm YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBCHqcHqHqcHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031078DV100310781003BEFWHITE DVQDVfBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A1-1L7RQC6Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-29BDVm YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBEHqdHqHqdHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031079DV100310791003BBFWHITE DVQDVfBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A01-1LGN4AFProcedure/Test not done Procedures/Tests SCREENING 1003SCR NO Non-Important2020-06-25`DVKYNYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBBHqeHqHqeHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031079DV100310791003BBFWHITE DVQDVfBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A 1-1KYFTDMProcedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1_DAY1_VAX1_S NO Non-Important2020-07-01ADVQ YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBBHqeHqHqeHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031079DV100310791003BBFWHITE DVQDVfBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A1-1LAORE6Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-29BDVm YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBBHqeHqHqeHq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031080DV100310801003BAFWHITE DVODVdBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A 1-1KYFT5BProcedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1_DAY1_VAX1_S NO Non-Important2020-06-30A DVP YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBAHqɺHq\HqɺHq\..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031080DV100310801003BAFWHITE DVODVdBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A01-1KYFT5EProcedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1003V1_DAY1_VAX1_S NO Non-Important2020-06-30A DVP YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBAHqɺHq\HqɺHq\..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031080DV100310801003BAFWHITE DVODVdBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A1-1L4FFZDRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-27BDVk YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBAHqɺHq\HqɺHq\..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031083DV100310831003BCFWHITE DVQDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA65-85 YearsA@A1-1LAORLDRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-30BDVn YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQPlacebo A`Placebo A`NA0>55 Years . NBCHqfLHr글HqfLHq|Hr Hr글Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031087DV100310871003BBMWHITE DVQDVfBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A1-1L7RQ5ZRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-07-29BDVm YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBBHqbHq HqbHq ..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031087DV100310871003BBMWHITE DVQDVfBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP65-85 YearsA@A 1-1OSVPCFVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003V8_MONTH6_S NO Non-Important2021-01-04BDW YYPhase 1 AStage 1, Age 65 to 85, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA0>55 Years . NBBHqbHq HqbHq ..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031088DV100310881003BFWHITE DVkDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124970201IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-26DVjYNYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NBHqTHrHqTHr $Hr6HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031088DV100310881003BFWHITE DVkDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 124971301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-16BDV YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NBHqTHrHqTHr $Hr6HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031089DV100310891003BIFWHITE DVkDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1OUAO1BVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1003COVID_A1 NO Non-Important2021-01-25BDW! YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NBIHqHr HqHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031092DV100310921003BEMWHITE DVlDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 124970401IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-27DVkYNYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBEHq,HrHq,Hr Hr{HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031092DV100310921003BEMWHITE DVlDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA0124971401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-17BDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBEHq,HrHq,Hr Hr{HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031092DV100310921003BEMWHITE DVlDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA126619501IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1003Vax 3 NO Non-Important2021-01-13BDW YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBEHq,HrHq,Hr Hr{HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031093DV100310931003BIMWHITE DVlDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA126618701IP documentation error IP preparation form errors Investigational ProductFOLLOW-UP 1003Vax 3 NO Non-Important2021-01-13BDW YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBIHqHr#HqHr HrDHr#Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031096DV100310961003BMBLACK OR AFRICAN AMERICAN DVlDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 124970501IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-27DVkYNYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NBHqHr HHqHr H..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW% YC4591001C4591001 1003 10031096DV100310961003BMBLACK OR AFRICAN AMERICAN DVlDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A0124971501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-17BDV YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NBHqHr HHqHr H..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW% YC4591001C4591001 1003 10031096DV100310961003BMBLACK OR AFRICAN AMERICAN DVlDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1R7E82IOther Informed Consent Informed Consent REPEAT SCREENING 1 1003Consent NO Non-Important2021-02-23BDW> YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NBHqHr HHqHr H..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW% YC4591001C4591001 1003 10031099DV100310991003BDFWHITE DVlDW1Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125340101IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-28ADVl YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBDHq9dHrHq9dHr pHrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031099DV100310991003BDFWHITE DVlDW1Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA0125344801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-18BDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBDHq9dHrHq9dHr pHrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031099DV100310991003BDFWHITE DVlDW1Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1NTA68XRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-10-21BVDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBDHq9dHrHq9dHr pHrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031100DV100311001003B*MWHITE DVlDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124970601IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-27DVkYNYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB*Hq6HsHq6Hr Hr8HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031100DV100311001003B*MWHITE DVlDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA AP1-1L82GC7Assessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests VACCINATION 1003V1 NO Non-Important2020-07-29A DVm YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB*Hq6HsHq6Hr Hr8HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031100DV100311001003B*MWHITE DVlDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 124971801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-17BDV YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB*Hq6HsHq6Hr Hr8HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031100DV100311001003B*MWHITE DVlDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A0127525601IP documentation error IRT Confirmation Report error Investigational ProductREPEAT SCREENING 1 1003Vax 3 NO Non-Important2021-01-31BDW' YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB*Hq6HsHq6Hr Hr8HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031100DV100311001003B*MWHITE DVlDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A@127525701IP documentation error Other Investigational ProductREPEAT SCREENING 1 1003Vax 3 NO Non-Important2021-01-31BDW' YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB*Hq6HsHq6Hr Hr8HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031101DV100311011003B+MWHITE DVlDW9Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125357501IP documentation error IP preparation form errors Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-27DVkYNYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB+Hq:HrCxHq:Hr Hr HrCxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031101DV100311011003B+MWHITE DVlDW9Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A0125340201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-28ADVl YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB+Hq:HrCxHq:Hr Hr HrCxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031101DV100311011003B+MWHITE DVlDW9Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A@125345001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-18BDV YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB+Hq:HrCxHq:Hr Hr HrCxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031101DV100311011003B+MWHITE DVlDW9Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NBLO98Subject received systemic corticosteroids (>=20mg/day of prednisone or equivalent) for >=14 days is prohibited from 28 days prior to enrollment to specified visits/cohorts per protocol. Concomitant MedicationsVACCINATION 1003V3_MONTH1_POSTVAX2_L YES-POP2,YES-POP3 Important 2020-09-09B,DV YYPhase 2_ds360/ds6000A . . .NA 18-55 Years. NB+Hq:HrCxHq:Hr Hr HrCxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031104DV100311041003B*MWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A124970701IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-28DVlYNYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NB*HqQHr HqQHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031104DV100311041003B*MWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A01-1LYAY42Nasal swab not collected for the visit where it is required Laboratory VACCINATION 1003POT_COVID_ILL NO Non-Important2020-08-06ADVu YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NB*HqQHr HqQHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031104DV100311041003B*MWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 124971901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-18BDV YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NB*HqQHr HqQHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031104DV100311041003B*MWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A@1-1NE4NXHVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003POT_COVID_CONVA NO Non-Important2020-09-16B2DV YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NB*HqQHr HqQHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031105DV100311051003BBMWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125340401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-29ADVm YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NBBHq|Hr ,Hq|Hr ,..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031105DV100311051003BBMWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125345201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-19BDV YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NBBHq|Hr ,Hq|Hr ,..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031105DV100311051003BBMWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA01-1O5BFLEVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003COVID_A1 NO Non-Important2020-12-01B~DV YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NBBHq|Hr ,Hq|Hr ,..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031108DV100311081003B<MWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA124970801IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-28DVlYNYPhase 2_ds360/ds6000A . . .YA0>55 Years . NB<Hq~Hr Hq~Hr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031108DV100311081003B<MWHITE DVmDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 124972001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-18BDV YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NB<Hq~Hr Hq~Hr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031109DV100311091003BSMWHITE DVnDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125340501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-30ADVn YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBSHqHr:lHqHr[HrمHr:lPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031109DV100311091003BSMWHITE DVnDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125345401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-20BDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBSHqHr:lHqHr[HrمHr:lPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031109DV100311091003BSMWHITE DVnDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1NZO4VNVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003COVID_A1 NO Non-Important2020-11-17BoDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBSHqHr:lHqHr[HrمHr:lPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031111DV100311111003BMWHITE DVnDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1PK6ZM7SAE report delayed or not reported to Sponsor Safety Reporting FOLLOW-UP 1003Potential ReVax Initial Contact NO Non-Important2020-12-17BDV YYPhase 2_ds360/ds6000A . . .NA 18-55 YearsA 16-25 YearsNBHqHsHqHr@0HrHHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW% YC4591001C4591001 1003 10031112DV100311121003BUMWHITE DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA124970901IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-29DVmYNYPhase 2_ds360/ds6000A . . .YA0>55 Years . NBUHqHrkHqHrk..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031112DV100311121003BUMWHITE DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 124972201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-19BDV YYPhase 2_ds360/ds6000A . . .YA0>55 Years . NBUHqHrkHqHrk..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031113DV100311131003BIMWHITE DVnDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125340601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-30ADVn YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBIHqȴHrl@HqȴHrl@..Placebo Placebo .. YC4591001C4591001 1003 10031113DV100311131003BIMWHITE DVnDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125345501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-20BDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBIHqȴHrl@HqȴHrl@..Placebo Placebo .. YC4591001C4591001 1003 10031113DV100311131003BIMWHITE DVnDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1NN1OE0SAE report delayed or not reported to Sponsor Safety Reporting FOLLOW-UP 1003COVID_A NO Non-Important2020-10-21BTDV YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBIHqȴHrl@HqȴHrl@..Placebo Placebo .. YC4591001C4591001 1003 10031113DV100311131003BIMWHITE DVnDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA@1-1R0T1FDVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1003V4_MONTH6_L NO Non-Important2021-02-26BDWA YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBIHqȴHrl@HqȴHrl@..Placebo Placebo .. YC4591001C4591001 1003 10031113DV100311131003BIMWHITE DVnDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APAP1-1R2MXMJVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1003COVID_B1 NO Non-Important2021-02-26BDWA YYPhase 2_ds360/ds6000A . . .NA0>55 Years . NBIHqȴHrl@HqȴHrl@..Placebo Placebo .. YC4591001C4591001 1003 10031115DV100311151003B&FASIAN DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A125340701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-30ADVn YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NB&HqHrlHqHrl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW% YC4591001C4591001 1003 10031115DV100311151003B&FASIAN DVnDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125345701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-20BDV YYPhase 2_ds360/ds6000A . . .YA 18-55 Years. NB&HqHrlHqHrl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW% YC4591001C4591001 1003 10031116DV100311161003B*FWHITE DVnDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124971101IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-29DVmYNYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB*HqDHr5HqDHrDHrHr5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031116DV100311161003B*FWHITE DVnDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 124972301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-20BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB*HqDHr5HqDHrDHrHr5Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031119DV100311191003BAFWHITE DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125340801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBAHqHrίHqHrHr0HrίPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031119DV100311191003BAFWHITE DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125345901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-21BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBAHqHrίHqHrHr0HrίPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031119DV100311191003BAFWHITE DVoDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1NSJ9Q5Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003POT_COVID_CONVA NO Non-Important2020-10-07BEDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBAHqHrίHqHrHr0HrίPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031120DV100311201003B<FWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA@124971201IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-07-30DVnYNYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HqHr`HqHr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031120DV100311201003B<FWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA122290101Dosing/administration error, subject did not receive correct dose of vaccine Investigational ProductVACCINATION 1003Vax 1 YES-POP2,YES-POP3 Important 2020-07-31ADVo YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HqHr`HqHr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031120DV100311201003B<FWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125353301IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HqHr`HqHr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031120DV100311201003B<FWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA0125353401IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HqHr`HqHr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031120DV100311201003B<FWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APAP124972401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-20BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HqHr`HqHr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031121DV100311211003BIMWHITE DVoDW6Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125340901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBIHqHrw HqHrHri`Hrw Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW# YC4591001C4591001 1003 10031121DV100311211003BIMWHITE DVoDW6Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125346001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-21BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBIHqHrw HqHrHri`Hrw Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW# YC4591001C4591001 1003 10031121DV100311211003BIMWHITE DVoDW6Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1NSJ9Q8Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003POT_COVID_CONVA NO Non-Important2020-10-12BJDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBIHqHrw HqHrHri`Hrw Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW# YC4591001C4591001 1003 10031122DV100311221003B0MWHITE DVoDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125341001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB0HqݼHs`HqݼHrHr4Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031122DV100311221003B0MWHITE DVoDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125346201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-21BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB0HqݼHs`HqݼHrHr4Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031123DV100311231003B@MWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125353701IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB@HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031123DV100311231003B@MWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125353901IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB@HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031124DV100311241003BFWHITE DVoDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125335401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .NA 18-55 YearsA 16-25 YearsNBHq,HrKHq,HrHrͻHrKPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031124DV100311241003BFWHITE DVoDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125342401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-21BDV YYPhase 3_ds6000 A0 . . .NA 18-55 YearsA 16-25 YearsNBHq,HrKHq,HrHrͻHrKPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031125DV100311251003B"FWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A125354101IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB"HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031125DV100311251003B"FWHITE DVoDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125354301IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-07-31ADVo YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB"HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031128DV100311281003B;FWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125335601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-03ADVr YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB;HqHryHqHry..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031128DV100311281003B;FWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125342501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-24BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB;HqHryHqHry..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031129DV100311291003B=MWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125351201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-03ADVr YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB=HqҴHr|HqҴHr|..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW# YC4591001C4591001 1003 10031129DV100311291003B=MWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125350901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-24BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB=HqҴHr|HqҴHr|..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW# YC4591001C4591001 1003 10031131DV100311311003B9MWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125351301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-03ADVr YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB9HqHr@HqHr@..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031131DV100311311003B9MWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125351501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-24BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB9HqHr@HqHr@..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031132DV100311321003B=MWHITE DVrDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125356601IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-03ADVr YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB=Hq4Hr:0Hq4HrHrEHr:0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031132DV100311321003B=MWHITE DVrDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125335801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-03ADVr YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB=Hq4Hr:0Hq4HrHrEHr:0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031132DV100311321003B=MWHITE DVrDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA0125342601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-24BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB=Hq4Hr:0Hq4HrHrEHr:0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031133DV100311331003B<MWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125351801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-03ADVr YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031133DV100311331003B<MWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125351601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-24BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031135DV100311351003B?FWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125352101IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-03ADVr YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB?HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031135DV100311351003B?FWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125352401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-24BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB?HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031135DV100311351003B?FWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA01-1NRD49HPotential COVID-19 illness visit not done when required per protocol. Visit Schedule FOLLOW-UP 1003V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-19BNDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB?HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031136DV100311361003B:FWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125336601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-03ADVr YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq HrHq Hr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031136DV100311361003B:FWHITE DVrDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125342701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-24BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq HrHq Hr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031137DV100311371003B)MWHITE DVsDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1PDYN62Visit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1003COVID_A1 NO Non-Important2021-02-09BDW0 YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB)Hq.Hr݌Hq.Hr݌..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031139DV100311391003B:MWHITE DVsDW@Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1R2MXMNVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1003COVID_A1 NO Non-Important2021-03-02BDWE YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB:Hq0(HsHq0(Hr44HrHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031140DV100311401003B!MWHITE ..Placebo PLACEBO Not Treated NOTTRT Placebo A.16-55 YearsA A1-1N8HJMGRandomization done out of sequence Randomization SCREENING 1003V1_DAY1_VAX1_L NO Non-Important2020-08-04ADVs NYPhase 3 A@ . . .NA 18-55 Years. NB!...... .. YC4591001C4591001 1003 10031142DV100311421003B=FWHITE DVsDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125341101IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-04ADVs YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB=HqrHrxHqrHr\HrbHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031142DV100311421003B=FWHITE DVsDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125346301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-25BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB=HqrHrxHqrHr\HrbHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031142DV100311421003B=FWHITE DVsDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA0126617401IP documentation error IRT Confirmation Report error Investigational ProductOPEN LABEL TREATMENT1003Vax 3 NO Non-Important2021-01-14BDW YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB=HqrHrxHqrHr\HrbHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031142DV100311421003B=FWHITE DVsDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA@126617501IP documentation error IRT Confirmation Report error Investigational ProductOPEN LABEL TREATMENT1003Vax 3 NO Non-Important2021-01-14BDW YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB=HqrHrxHqrHr\HrbHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031143DV100311431003B)MWHITE ..BNT162b2 Phase 2/3 (30 mcg) B2_P23_30Not Treated NOTTRT BNT162b2 Phase 2/3 (30 mcg) A.16-55 YearsA A1-1MFFVV5Randomization done out of sequence Randomization SCREENING 1003V1_DAY1_VAX1_L NO Non-Important2020-08-04ADVs NYPhase 3 A@ . . .NA 18-55 Years. NB)...... .. YC4591001C4591001 1003 10031144DV100311441003B5MWHITE DVsDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A125337701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-04ADVs YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB5Hqr@HrϸHqr@Hrϸ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031144DV100311441003B5MWHITE DVsDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125342801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-25BDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB5Hqr@HrϸHqr@Hrϸ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031147DV100311471003B&FWHITE DVtDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125341301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-05ADVt YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB&HqHrϨHqHr3DHrkdHrϨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031147DV100311471003B&FWHITE DVtDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125346401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-26BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB&HqHrϨHqHr3DHrkdHrϨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031147DV100311471003B&FWHITE DVtDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1O4WYVUVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003COVID_A1 NO Non-Important2020-11-19BkDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB&HqHrϨHqHr3DHrkdHrϨPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031148DV100311481003BIFWHITE DVtDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125337901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-05ADVt YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBIHqHr5$HqHr5$..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031148DV100311481003BIFWHITE DVtDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125342901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-26BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBIHqHr5$HqHr5$..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031151DV100311511003B7MWHITE DVtDW#Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125483701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-05ADVt YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB7Hq Hr:Hq HrqHr$Hr:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031151DV100311511003B7MWHITE DVtDW#Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1LGCS44Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1003V1 NO Non-Important2020-08-11ApDVz YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB7Hq Hr:Hq HrqHr$Hr:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031151DV100311511003B7MWHITE DVtDW#Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125483801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-26BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB7Hq Hr:Hq HrqHr$Hr:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031151DV100311511003B7MWHITE DVtDW#Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A@1-1OSE3F7Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003COVID_A1 NO Non-Important2020-12-29BDW YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB7Hq Hr:Hq HrqHr$Hr:Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031152DV100311521003B@MWHITE DVtDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125338001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-05ADVt YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB@HqTHrtlHqTHrtl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031152DV100311521003B@MWHITE DVtDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125343001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-26BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB@HqTHrtlHqTHrtl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031152DV100311521003B@MWHITE DVtDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA01-1O5VLANVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003COVID_A1 NO Non-Important2020-12-02BxDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB@HqTHrtlHqTHrtl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031153DV100311531003B:FWHITE DVuDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125341401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-06ADVu YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq8HrјHq8Hrј..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031153DV100311531003B:FWHITE DVuDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA@1-1N9T29UUrine pregnancy test not performed. Laboratory VACCINATION 1003V1_DAY1_VAX1_L NO Non-Important2020-08-06ADVu YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq8HrјHq8Hrј..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031153DV100311531003B:FWHITE DVuDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA0125346601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-25BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq8HrјHq8Hrј..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031153DV100311531003B:FWHITE DVuDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APAP1-1N9T2GLUrine pregnancy test not performed. Laboratory VACCINATION 1003V2_VAX2_L NO Non-Important2020-08-25BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq8HrјHq8Hrј..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031153DV100311531003B:FWHITE DVuDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1NTA693Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent FOLLOW-UP 1003Consent NO Non-Important2020-10-26BRDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq8HrјHq8Hrј..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031156DV100311561003B3FWHITE DVuDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125338101IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-06ADVu YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB3HqHrHqHrXHr HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031156DV100311561003B3FWHITE DVuDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125343101IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-27BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB3HqHrHqHrXHr HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031156DV100311561003B3FWHITE DVuDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1P93YSKUrine pregnancy test not performed. Laboratory FOLLOW-UP 1003V101_VAX3 NO Non-Important2020-09-24B2DV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB3HqHrHqHrXHr HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031156DV100311561003B3FWHITE DVuDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A@1-1QVZNVNUrine pregnancy test not performed. Laboratory FOLLOW-UP 1003V102_VAX4 NO Non-Important2020-09-24B2DV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB3HqHrHqHrXHr HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031160DV100311601003BMASIAN DVuDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A125338301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-06ADVu YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NBHqPHrHqPHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031160DV100311601003BMASIAN DVuDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125343201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-27BDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NBHqPHrHqPHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031161DV100311611003B7FWHITE DVvDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125341501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-07ADVv YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB7Hq<HrwHq<HrHrgHrwPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031161DV100311611003B7FWHITE DVvDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125346701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-28BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB7Hq<HrwHq<HrHrgHrwPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031162DV100311621003B7FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A125357201IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-07ADVv YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB7HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031162DV100311621003B7FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125341601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-07ADVv YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB7HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031162DV100311621003B7FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A0125346901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-28BDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB7HqHrHqHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031163DV100311631003B;MWHITE DVvDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1NDY34NVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003V3_MONTH1_POSTVAX2_L NO Non-Important2020-09-24B1DV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB;HqHrPHqHrȬHrHrPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031163DV100311631003B;MWHITE DVvDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1NE4NXKVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003Visit 3 NO Non-Important2020-09-24B1DV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB;HqHrPHqHrȬHrHrPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031163DV100311631003B;MWHITE DVvDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA127525401IP documentation error IP preparation form errors Investigational ProductOPEN LABEL TREATMENT1003Vax 3 NO Non-Important2021-01-29BDW% YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB;HqHrPHqHrȬHrHrPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031164DV100311641003BLMWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125356901IP documentation error IP preparation form errors Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-08-03@DVrYNYPhase 3_ds6000 A0 . . .YA0>55 Years . NBLHq Hr`Hq Hr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031164DV100311641003BLMWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125338401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-07ADVv YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBLHq Hr`Hq Hr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031164DV100311641003BLMWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA0125343301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-28BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBLHq Hr`Hq Hr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031164DV100311641003BLMWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA@1-1NSJ9QBVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003POT_COVID_CONVA NO Non-Important2020-10-16BGDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBLHq Hr`Hq Hr`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031166DV100311661003B3MWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1QZNZ8TReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsFOLLOW-UP 1003V2_VAX2_L YES-POP2,YES-POP3 Important 2021-01-07BDW YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB3Hq<Hr|Hq<Hr|..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031167DV100311671003B9FWHITE DVvDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125341701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-07ADVv YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB9Hq>pHrHq>pHrlHrVlHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031167DV100311671003B9FWHITE DVvDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125347001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-28BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB9Hq>pHrHq>pHrlHrVlHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031168DV100311681003B:FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125338501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-07ADVv YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq=HrdHq=Hrd..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031168DV100311681003B:FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125343401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-28BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB:Hq=HrdHq=Hrd..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031170DV100311701003B!FWHITE DVyDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1RSWB8DVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1003V102_VAX4 NO Non-Important2021-01-13BDW YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB!Hr HrήHr Hr$Hr;HrήPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031172DV100311721003B8MWHITE DVyDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125338601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-10ADVy YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB8Hr 4HrPHr 4HrP..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031172DV100311721003B8MWHITE DVyDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125343501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-31BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB8Hr 4HrPHr 4HrP..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031172DV100311721003B8MWHITE DVyDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA01-1N9RVLTNasal swab not collected for the visit where it is required Laboratory VACCINATION 1003POT_COVID_ILL NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB8Hr 4HrPHr 4HrP..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031174DV100311741003B!MWHITE DVyDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1SMY97ZVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL FOLLOW-UP1003V103_MONTH1 NO Non-Important2021-02-03BDW* YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB!HrTHrw HrTHrHrfHrw Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031175DV100311751003B6FWHITE DVyDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A126617201IP documentation error IRT Confirmation Report error Investigational ProductOPEN LABEL TREATMENT1003Vax 3 NO Non-Important2021-01-14BDW YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB6HrVHrEHrVHr$HraHrEPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031175DV100311751003B6FWHITE DVyDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 126617301IP documentation error IRT Confirmation Report error Investigational ProductOPEN LABEL TREATMENT1003Vax 3 NO Non-Important2021-01-14BDW YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB6HrVHrEHrVHr$HraHrEPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031176DV100311761003BFMWHITE DVyDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125338701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-10ADVy YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBFHrWHrpHrWHrp..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031176DV100311761003BFMWHITE DVyDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125343601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-08-31BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBFHrWHrpHrWHrp..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031179DV100311791003B(MWHITE DVzDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125341801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-11ADVz YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB(HrkHshHrkHrHrHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031179DV100311791003B(MWHITE DVzDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125347201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB(HrkHshHrkHrHrHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031179DV100311791003B(MWHITE DVzDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1N9RVLXNasal swab not collected for the visit where it is required Laboratory VACCINATION 1003POT_COVID_ILL NO Non-Important2020-09-08BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB(HrkHshHrkHrHrHshPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW$ YC4591001C4591001 1003 10031180DV100311801003B+FWHITE DVzDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A125338901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-11ADVz YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB+HriHrLHriHrL..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031180DV100311801003B+FWHITE DVzDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125343701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB+HriHrLHriHrL..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031181DV100311811003B8FWHITE DVzDW Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1N9T2GOUrine pregnancy test not performed. Laboratory VACCINATION 1003V2_VAX2_L NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB8HrjHr^HrjHr<HryHr^Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031182DV100311821003B<MBLACK OR AFRICAN AMERICAN DVzDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125341901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-11ADVz YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HrlHr HrlHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031182DV100311821003B<MBLACK OR AFRICAN AMERICAN DVzDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125347401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HrlHr HrlHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031182DV100311821003B<MBLACK OR AFRICAN AMERICAN DVzDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA01-1O81WAWVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003COVID_A1 NO Non-Important2020-12-08BxDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB<HrlHr HrlHr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031184DV100311841003B4MWHITE DVzDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125339001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-11ADVz YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB4HrpHrŹHrpHrZHrj,HrŹPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031184DV100311841003B4MWHITE DVzDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125343801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB4HrpHrŹHrpHrZHrj,HrŹPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031186DV100311861003B!MWHITE DV{DW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1SSSGA6Participant met exclusion criterion #11 (women who are pregnant or breastfeeding) Inclusion/Exclusion VACCINATION 1003V3_MONTH1_POSTVAX2_L YES-POP2,YES-POP3 Important 2020-09-17B%DV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB!HrHrGHrHr Hr֮HrGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031187DV100311871003B"MWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A125358201IP documentation error IP preparation form errors Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-08-11DVzYNYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB"HrHr,HrHr,..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031187DV100311871003B"MWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125358001IP documentation error IP preparation form errors Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-12ADV{ YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB"HrHr,HrHr,..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031187DV100311871003B"MWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A0125342101IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-12ADV{ YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB"HrHr,HrHr,..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031187DV100311871003B"MWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A@125347601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB"HrHr,HrHr,..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031188DV100311881003B=MWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA125339201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-12ADV{ YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB=HrHrd(HrHrd(..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031188DV100311881003B=MWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 125344001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-02BDV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB=HrHrd(HrHrd(..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1003 10031192DV100311921003B<FWHITE DV{DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125339301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-12ADV{ YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB<HrHrŽHrHrY4HriHrŽPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031192DV100311921003B<FWHITE DV{DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125344101IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB<HrHrŽHrHrY4HriHrŽPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031196DV100311961003B,FWHITE DV|DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125339501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-13ADV| YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB,HrQdHrŘHrQdHr HrxHrŘPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031196DV100311961003B,FWHITE DV|DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125344301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-03BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB,HrQdHrŘHrQdHr HrxHrŘPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031199DV100311991003B%FWHITE DV|DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A125342201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-13ADV| YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB%HrRHr!0HrRHr!0..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031199DV100311991003B%FWHITE DV|DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125347701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-03BDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB%HrRHr!0HrRHr!0..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031199DV100311991003B%FWHITE DV|DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A01-1N9T2GRUrine pregnancy test not performed. Laboratory VACCINATION 1003V2_VAX2_L NO Non-Important2020-09-03BDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB%HrRHr!0HrRHr!0..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1003 10031200DV100312001003BDFWHITE DV|DW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA125339701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-13ADV| YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBDHrTHr\HrTHr! Hr2XHr\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031200DV100312001003BDFWHITE DV|DW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 125344401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-03BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBDHrTHr\HrTHr! Hr2XHr\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031204DV100312041003B'FWHITE DV}DW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125357801IP documentation error IP preparation form errors Investigational ProductSCREENING 1003Vax 1 NO Non-Important2020-08-13DV|YNYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB'HrRHr<HrRHr!HrFHr<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031204DV100312041003B'FWHITE DV}DW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A0125339801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-14ADV} YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB'HrRHr<HrRHr!HrFHr<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031204DV100312041003B'FWHITE DV}DW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A@125344501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-04BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB'HrRHr<HrRHr!HrFHr<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031204DV100312041003B'FWHITE DV}DW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA AP1-1NJ3X2PVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-01B1DV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB'HrRHr<HrRHr!HrFHr<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031204DV100312041003B'FWHITE DV}DW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 126619201IP documentation error IP preparation form errors Investigational ProductOPEN LABEL TREATMENT1003Vax 3 NO Non-Important2021-01-14BDW YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB'HrRHr<HrRHr!HrFHr<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031206DV100312061003B5MWHITE DV}DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125340001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 1 NO Non-Important2020-08-14ADV} YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB5HrHrHrHr"HrͼHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031206DV100312061003B5MWHITE DV}DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 125344701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1003Vax 2 NO Non-Important2020-09-04BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB5HrHrHrHr"HrͼHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031206DV100312061003B5MWHITE DV}DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1NV2UO4Nasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1003COVID_A NO Non-Important2020-10-26BJDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB5HrHrHrHr"HrͼHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1003 10031206DV100312061003B5MWHITE DV}DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A@1-1O5WOZPVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1003COVID_A1 NO Non-Important2020-12-02BoDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB5HrHrHrHr"HrͼHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051002DV100510021005B3FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NJZ0M1Visit not done Visit Schedule VACCINATION 1005V2_VAX2_L NO Non-Important2020-09-17B*DV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB3Hq3Hr}Hq3Hr}..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051002DV100510021005B3FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A01-1NIHIAMVisit not done Visit Schedule VACCINATION 1005V1_DAY1_VAX1_L NO Non-Important2020-09-19B,DV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB3Hq3Hr}Hq3Hr}..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051002DV100510021005B3FWHITE DVvDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1RUUMAWSubject/LAR signed a superseded/outdated version of the ICD Informed Consent FOLLOW-UP 1005Consent NO Non-Important2021-02-09BDW0 YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB3Hq3Hr}Hq3Hr}..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051005DV100510051005B?FWHITE DVyDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1R28RNXNasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1005COVID_A NO Non-Important2020-12-23BDW YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB?Hr0Hr Hr0Hr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW# YC4591001C4591001 1005 10051007DV100510071005B6FWHITE DVyDW+Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1PMFRLCVisit not done Visit Schedule OPEN LABEL TREATMENT1005COVID_A1 NO Non-Important2021-02-25BDW@ YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB6Hr.@Hr먼Hr.@HrpHr Hr먼Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051019DV100510191005BJFWHITE DVzDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1SKKCBHReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1005V3_MONTH1_POSTVAX2_L YES-POP2,YES-POP3 Important 2021-01-12BDW YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBJHrlHrHrlHr..Placebo Placebo .. YC4591001C4591001 1005 10051022DV100510221005BSFWHITE DVzDW8Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1NRDOGIPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-08-18ADV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBSHrHr3 HrHrHrHr3 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051022DV100510221005BSFWHITE DVzDW8Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1P25D91Subject/LAR did not sign placebo transition ICD addendum & did not give verbal consent Informed Consent OPEN LABEL TREATMENT1005Consent NO Non-Important2021-02-17BDW8 YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBSHrHr3 HrHrHrHr3 Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051035DV100510351005BMWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1R28RO1Nasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1005COVID_B NO Non-Important2020-12-30BDW YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NBHrHrOHrHrO..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1005 10051036DV100510361005BMWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NRDOGLPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-08-19ADV YYPhase 3_ds6000 A0 . . .YA 18-55 YearsA 16-25 YearsNBHrHr"HrHr"..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW" YC4591001C4591001 1005 10051061DV100510611005B8MWHITE DV|DWLPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1NUUK5HVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1005V2_VAX2_L NO Non-Important2020-09-08BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NB8HrVHs,HrVHr'=HrHs,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051062DV100510621005BIMWHITE DV|DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1T5CS3EOther Informed Consent Informed Consent REPEAT SCREENING 1 1005Consent NO Non-Important2021-01-19BDW YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBIHrOHHrlHrOHHrl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051062DV100510621005BIMWHITE DV|DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 1-1RVVUHDNasal swab collected at a visit where it was not required Laboratory REPEAT SCREENING 1 1005V101_VAX3 NO Non-Important2021-01-19BDW YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBIHrOHHrlHrOHHrl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051062DV100510621005BIMWHITE DV|DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA01-1R2NXVCSerology sample collected at a visit where it is not required Laboratory REPEAT SCREENING 1 1005V101_VAX3 NO Non-Important2021-01-19BDW YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBIHrOHHrlHrOHHrl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051063DV100510631005B;MWHITE DV|DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1NRDOGOPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-08-27ADV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB;Hr]Hr]lHr]Hr]l..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051074DV100510741005BQFWHITE DV}DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1R28RO4Nasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1005COVID_A NO Non-Important2020-12-29BDW YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBQHriHrsHriHrs..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051074DV100510741005BQFWHITE DV}DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 1-1R7C46UVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1005COVID_A1 NO Non-Important2021-03-09BDWL YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBQHriHrsHriHrs..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051079DV100510791005B,MWHITE DVDWMPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NLKX5YVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-15B:DV YYPhase 3 A@ . . .NA 18-55 Years. NB,Hr HHs\Hr HHr(HrHs\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051081DV100510811005B,FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1OSP6X9Nasal swab not collected for the visit where it is required Laboratory VACCINATION 1005COVID_A NO Non-Important2020-09-10BDV YYPhase 3 A@ . . .YA 18-55 Years. NB,Hr Hr*0Hr Hr*0..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051081DV100510811005B,FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1OH0NVZVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1005POT_COVID_ILL NO Non-Important2020-09-10BDV YYPhase 3 A@ . . .YA 18-55 Years. NB,Hr Hr*0Hr Hr*0..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051098DV100510981005BKMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1SN4OEQOther Informed Consent Informed Consent REPEAT SCREENING 1 1005Consent NO Non-Important2021-03-09BDWL YYPhase 3 A@ . . .YA0>55 Years . NBKHrHr(lHrHr(l..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051104DV100511041005B8FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1PG5YJLParticipant randomized into incorrect age stratum in Impala Randomization VACCINATION 1005V1_DAY1_VAX1 NO Non-Important2020-08-20ADV YYPhase 3 A@ . . .YA0>55 Years . NB8Hr@Hr*EHr@Hr*E..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051120DV100511201005B:FWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1OTC7PYProcedure not performed as part of vital signs. Procedures/Tests REPEAT SCREENING 1 1005V101_VAX3 NO Non-Important2021-01-18BDW YYPhase 3 A@ . . .NA0>55 Years . NB:Hr0HrC Hr0Hr/:`Hr֑pHrC Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051126DV100511261005BDFWHITE DVDW2Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1PO9520Nasal swab not collected by site staff prior to vaccination. Laboratory OPEN LABEL TREATMENT1005V102_VAX4 NO Non-Important2021-02-12BDW3 YYPhase 3 A@ . . .NA0>55 Years . NBDHr$HrHr$Hr/sHrG0HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051130DV100511301005BEMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1M5CU73Other Informed Consent Informed Consent VACCINATION 1005Consent NO Non-Important2020-08-24ADV YYPhase 3 A@ . . .YA0>55 Years . NBEHrHr2HrHr2..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW0 YC4591001C4591001 1005 10051145DV100511451005B/FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NZMJXOPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005POT_COVID_ILL NO Non-Important2020-09-07ADV YYPhase 3 A@ . . .YA 18-55 Years. NB/HrHr/)HrHr/)..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051145DV100511451005B/FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NX0MJXPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005POT_COVID_ILL NO Non-Important2020-09-20BDV YYPhase 3 A@ . . .YA 18-55 Years. NB/HrHr/)HrHr/)..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051147DV100511471005BFWHITE DVDW7Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NKINAXVisit not done Visit Schedule VACCINATION 1005POT_COVID_ILL NO Non-Important2020-10-12B1DV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHr0HrxdHr0Hr3eHr`HrxdPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW! YC4591001C4591001 1005 10051150DV100511501005B4MWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1OH0NW2Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1005COVID_A NO Non-Important2020-11-19BVDV YYPhase 3 A@ . . .NA 18-55 Years. NB4HrHrpHrHr/#HrHrpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051150DV100511501005B4MWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OQLOG4Other Informed Consent Informed Consent OPEN LABEL TREATMENT1005Consent NO Non-Important2021-01-19BDW YYPhase 3 A@ . . .NA 18-55 Years. NB4HrHrpHrHr/#HrHrpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051162DV100511621005BCFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1R28RPBNasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1005COVID_C NO Non-Important2021-01-01BDW YYPhase 3 A@ . . .YA0>55 Years . NBCHrb`Hr2Hrb`Hr2..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051165DV100511651005B5MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NIGAUSVisit not done Visit Schedule VACCINATION 1005V1_DAY1_VAX1_L NO Non-Important2020-09-14BDV YYPhase 3 A@ . . .YA 18-55 Years. NB5HrxHr3$HrxHr3$..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051165DV100511651005B5MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NRDOGRPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-09-15BDV YYPhase 3 A@ . . .YA 18-55 Years. NB5HrxHr3$HrxHr3$..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051172DV100511721005BDFWHITE DVDWDPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1R0DERJVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1005V102_VAX4 NO Non-Important2021-03-01BDWD YYPhase 3 A@ . . .NA0>55 Years . NBDHr|Hs Hr|HrAHr Hs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW% YC4591001C4591001 1005 10051178DV100511781005B4MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NRDOGUPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-01B#DV YYPhase 3 A@ . . .YA 18-55 Years. NB4Hr8Hr4Hr8Hr4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW- YC4591001C4591001 1005 10051178DV100511781005B4MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1OI3VCAVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1005POT_COVID_ILL NO Non-Important2020-12-16BoDV YYPhase 3 A@ . . .YA 18-55 Years. NB4Hr8Hr4Hr8Hr4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW- YC4591001C4591001 1005 10051179DV100511791005B1FWHITE DVDWNPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NUXWA6Potential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005V1_DAY1_VAX1_L NO Non-Important2020-08-28ADV YYPhase 3 A@ . . .NA 18-55 Years. NB1HrHsHrHr30HrHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1005 10051183DV100511831005B3MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NUXWAJNasal swab not collected for the visit where it is required Laboratory VACCINATION 1005COVID_A NO Non-Important2020-09-23BDV YYPhase 3 A@ . . .YA 18-55 Years. NB3HrxHr;LHrxHr;L..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051183DV100511831005B3MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A01-1NX0MK1Potential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005POT_COVID_ILL NO Non-Important2020-09-23BDV YYPhase 3 A@ . . .YA 18-55 Years. NB3HrxHr;LHrxHr;L..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051183DV100511831005B3MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NWZG47Nasal swab not collected for the visit where it is required Laboratory VACCINATION 1005COVID_A NO Non-Important2020-09-24BDV YYPhase 3 A@ . . .YA 18-55 Years. NB3HrxHr;LHrxHr;L..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051183DV100511831005B3MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A@1-1R0DD45Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1005POT_COVID_CONVA NO Non-Important2020-11-09BGDV YYPhase 3 A@ . . .YA 18-55 Years. NB3HrxHr;LHrxHr;L..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051184DV100511841005BDMWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1NRDOGXPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-13B,DV YYPhase 3 A@ . . .NA0>55 Years . NBDHrxHrGHrxHr8XHrdHrGPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051186DV100511861005B=FWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1OTQLQ3Procedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1005V101_VAX3 NO Non-Important2020-12-15BkDV YYPhase 3 A@ . . .NA0>55 Years . NB=HrHrŲHrHr8HrHrŲPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051187DV100511871005B,FWHITE DVDW1Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1P19OB8Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent OPEN LABEL TREATMENT1005Consent NO Non-Important2021-01-18BDW YYPhase 3 A@ . . .NA 18-55 Years. NB,Hr$Hr$Hr$Hr8HrsHr$Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051191DV100511911005B?MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1R6YWZLVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1005V4_MONTH6_L NO Non-Important2021-03-08BDWK YYPhase 3 A@ . . .YA0>55 Years . NB?Hr@Hr8Hr@Hr8..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1005 10051200DV100512001005B&MWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NRDOH0Potential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005COVID_A NO Non-Important2020-09-17ADV YYPhase 3 A@ . . .NA 18-55 Years. NB&Hr HrTHr Hr:Hr֟HrTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051200DV100512001005B&MWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1NIGAUWVisit not done Visit Schedule VACCINATION 1005V1_DAY1_VAX1_L NO Non-Important2020-09-18BDV YYPhase 3 A@ . . .NA 18-55 Years. NB&Hr HrTHr Hr:Hr֟HrTPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051203DV100512031005B$MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NU6CWBPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005POT_COVID_ILL NO Non-Important2020-09-19BDV YYPhase 3 A@ . . .YA 18-55 Years. NB$Hr Hr9@Hr Hr9@..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1005 10051205DV100512051005B9FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1T9XLGHSubject received the season influenza vaccine or the pandemic influenza vaccine within 14 days prior to or 14 days after the administration of IP. Concomitant MedicationsVACCINATION 1005V2_VAX2_L NO Non-Important2020-10-01BDV YYPhase 3 A@ . . .YA0>55 Years . NB9Hr \Hr55 Years APA1-1NNMKSLSubject received the season influenza vaccine or the pandemic influenza vaccine within 14 days prior to or 14 days after the administration of IP. Concomitant MedicationsFOLLOW-UP 1005V2_VAX2_L NO Non-Important2020-10-22B2DV YYPhase 3 A@ . . .NA0>55 Years . NBCHr @Hr`Hr @Hr;)tHrEHHr`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051211DV100512111005BEMWHITE DVDW1Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1NH2754Subject received the season influenza vaccine or the pandemic influenza vaccine within 14 days prior to or 14 days after the administration of IP. Concomitant MedicationsVACCINATION 1005V1_DAY1_VAX1_L NO Non-Important2020-09-10ADV YYPhase 3 A@ . . .NA0>55 Years . NBEHr hHrHr hHr=HrpHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051214DV100512141005BGFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1NDZWA7Visit not done Visit Schedule VACCINATION 1005V1_DAY1_VAX1_L NO Non-Important2020-09-10ADV YYPhase 3 A@ . . .NA0>55 Years . NBGHr Hr Hr Hr ..BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051216DV100512161005BFWHITE DVDWGPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NRDOHNPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1005POT_COVID_ILL NO Non-Important2020-09-13ADV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHr!HsHr!Hr55 Years APA1-1OI3VCDVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1005POT_COVID_ILL NO Non-Important2020-12-14B>DV YYPhase 3 A@ . . .NA0>55 Years . NB=HrVpHs @HrVpHrr_Hs @Hs @Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051264DV100512641005BFWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NU2E0HNasal swab not collected for the visit where it is required Laboratory VACCINATION 1005COVID_A NO Non-Important2020-10-20A`DV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHrX'HrHrX'Hrr Hr<HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051264DV100512641005BFWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1OE6UYYVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-12-10B9DV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHrX'HrHrX'Hrr Hr<HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051276DV100512761005B7FWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OH0NW5Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1005COVID_A NO Non-Important2020-11-16B!DV YYPhase 3 A@ . . .NA 18-55 Years. NB7HrXlHrƬHrXlHrrHrm`HrƬPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051287DV100512871005B=MWHITE DVDWFPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1O5ZC17Subject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsVACCINATION 1005V2_VAX2_L NO Non-Important2020-11-04BDV YYPhase 3 A@ . . .NA0>55 Years . NB=HrYxHsOLHrYxHrrd\HrHsOLPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW, YC4591001C4591001 1005 10051293DV100512931005B<MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1O073MVNasal swab not collected for the visit where it is required Laboratory VACCINATION 1005COVID_A NO Non-Important2020-11-09BDV YYPhase 3 A@ . . .NA0>55 Years . NB<Hr]JHr]JHr]JHr]J..BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1005 10051293DV100512931005B<MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 1-1OH0NW8Visit not done Visit Schedule VACCINATION 1005COVID_A1 NO Non-Important2020-11-09BDV YYPhase 3 A@ . . .NA0>55 Years . NB<Hr]JHr]JHr]JHr]J..BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1005 10051296DV100512961005BAMWHITE DVDW/Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1PE2KY5Nasal swab not collected for the visit where it is required Laboratory VACCINATION 1005COVID_A NO Non-Important2020-11-17BDV YYPhase 3 A@ . . .NA0>55 Years . NBAHr]aHrxHr]aHrxHr>LHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051296DV100512961005BAMWHITE DVDW/Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1QVIYDPVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1005COVID_A1 NO Non-Important2021-02-24BDW? YYPhase 3 A@ . . .NA0>55 Years . NBAHr]aHrxHr]aHrxHr>LHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051301DV100513011005B7MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1PI38IZNasal swab not collected for the visit where it is required Laboratory REPEAT SCREENING 1 1005COVID_A NO Non-Important2021-02-09BrDW0 YYPhase 3 A@ . . .NA 18-55 Years. NB7Hr]uHry*Hr]uHry*..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW0 YC4591001C4591001 1005 10051312DV100513121005BFMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1NZ3BY9Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1005V2_VAX2_L NO Non-Important2020-11-13BDV YYPhase 3 A@ . . .NA0>55 Years . NBFHr]Hr~PHr]Hr~P..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051326DV100513261005B'FWHITE DVDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1P1CCN6Other Informed Consent Informed Consent OPEN LABEL TREATMENT1005Consent NO Non-Important2021-01-12BUDW YYPhase 3 A@ . . .NA 18-55 Years. NB'Hr^<Hr%Hr^<Hrzr(Hr͗(Hr%Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051338DV100513381005BIFWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1OS50B5Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1005V2_VAX2_L NO Non-Important2020-12-21B>DV YYPhase 3 A@ . . .NA0>55 Years . NBIHr`HrHr`Hr`Hr֐HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051341DV100513411005BFWHITE DVDW)Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1T8K0ZFVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL FOLLOW-UP1005V103_MONTH1 NO Non-Important2021-03-10BDWM YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHr`Hr3Hr`Hr`Hr͓,Hr3Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051343DV100513431005BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1OS50G8Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1005V3_MONTH1_POSTVAX2_L NO Non-Important2020-12-17B:DV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHr`+Hr{|Hr`+Hr{|..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1005 10051345DV100513451005B%MWHITE DVDW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1T8K0ZIVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL FOLLOW-UP1005V103_MONTH1 NO Non-Important2021-03-11BDWN YYPhase 3 A@ . . .NA 18-55 Years. NB%Hr`55 Years APA1-1SQ6OUBVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1005V102_VAX4 NO Non-Important2021-01-11BRDW YYPhase 3 A@ . . .NA0>55 Years . NB;HraATHrmHraATHr}UHra4HrmPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051385DV100513851005B%FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1OHEY29Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1005POT_COVID_ILL NO Non-Important2020-12-17B3DV YYPhase 3 A@ . . .NA 18-55 Years. NB%HrivHrtHrivHrt..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051390DV100513901005B&FWHITE DVDWMPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1PG5YJPParticipant randomized into incorrect age stratum in Impala Randomization VACCINATION 1005V1_DAY1_VAX1 NO Non-Important2020-10-30ADV YYPhase 3 A@ . . .NA 18-55 Years. NB&HrkԘHsHrkԘHr0HrHHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1005 10051390DV100513901005B&FWHITE DVDWMPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1P85LTSVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1005COVID_A1 NO Non-Important2021-02-03BaDW* YYPhase 3 A@ . . .NA 18-55 Years. NB&HrkԘHsHrkԘHr0HrHHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1005 10051392DV100513921005BGMWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1O2DZBZVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1005V2_VAX2_L NO Non-Important2020-11-23BDV YYPhase 3 A@ . . .NA0>55 Years . NBGHrk`HrUHrk`HrHrtHrUPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1005 10051403DV100514031005BBFWHITE DVDW>BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1QWOM8XVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1005V2_VAX2_L NO Non-Important2021-02-23BpDW> YYPhase 3 A@ . . .NA0>55 Years . NBBHrrPHsڼHrrPHsڼ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW0 YC4591001C4591001 1005 10051408DV100514081005BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1OV12MXOther Informed Consent Informed Consent FOLLOW-UP 1005Consent NO Non-Important2021-01-05B8DW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr{LHr@Hr{LHr@..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1005 10051411DV100514111005BFWHITE DWDW$BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1P9Y0WAVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1005V2_VAX2_L NO Non-Important2021-01-29BDW% YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr>hHr♘Hr>hHr♘..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW* YC4591001C4591001 1005 10051411DV100514111005BFWHITE DWDW$BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1QZKCA7SAE report delayed or not reported to Sponsor Safety Reporting REPEAT SCREENING 1 1005Potential ReVax Initial Contact NO Non-Important2021-02-04BDW+ YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr>hHr♘Hr>hHr♘..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW* YC4591001C4591001 1005 10051414DV100514141005AFWHITE DVDW Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1OT8117Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1005V2_VAX2_L NO Non-Important2021-01-04BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrEHrHrEHr..Placebo Placebo .. YC4591001C4591001 1005 10051419DV100514191005AFWHITE DVDW?Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1OT811BVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1005V2_VAX2_L NO Non-Important2021-01-04BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHr%Hsf\Hr%HrHsf\Hsf\Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1005 10051423DV100514231005BFBLACK OR AFRICAN AMERICAN DVDWNPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OTTPRBProcedure/Test not performed per protocol Procedures/Tests VACCINATION 1005V2_VAX2_L NO Non-Important2021-01-07BDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrlHs&HrlHr Hr+dHs&Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW0 YC4591001C4591001 1005 10051424DV100514241005AMWHITE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1OTC10GVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1005V2_VAX2_L NO Non-Important2021-01-08BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHroHrDHroHrD..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1005 10051426DV100514261005BMWHITE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1RVVUQ6Nasal swab collected at a visit where it was not required Laboratory VACCINATION 1005Covid_A NO Non-Important2021-01-05BDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHryHr&HryHr&..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1005 10051426DV100514261005BMWHITE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1RVVF3FVisit conducted when not required per protocol Visit Schedule REPEAT SCREENING 1 1005COVID_A1 NO Non-Important2021-02-04B.DW+ YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHryHr&HryHr&..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1005 10051427DV100514271005AFWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA 1-1SSTN91Nasal swab collected at a visit where it was not required Laboratory VACCINATION 1005COVID A NO Non-Important2021-01-05BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrzDHr%PHrzDHr%P..Placebo Placebo .. YC4591001C4591001 1005 10051427DV100514271005AFWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA01-1OTC0WAProcedure not performed as part of vital signs. Procedures/Tests VACCINATION 1005V2_VAX2_L NO Non-Important2021-01-08BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrzDHr%PHrzDHr%P..Placebo Placebo .. YC4591001C4591001 1005 10051427DV100514271005AFWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA@1-1RVVF3JVisit conducted when not required per protocol Visit Schedule VACCINATION 1005COVID_A1 NO Non-Important2021-02-04B.DW+ YYPhase 3 A@ . . .N. A12-15 YearsNAHrzDHr%PHrzDHr%P..Placebo Placebo .. YC4591001C4591001 1005 10051427DV100514271005AFWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1R54FU9Lab performed out of window Laboratory REPEAT SCREENING 1 1005SSWAB_WEEK4 NO Non-Important2021-03-11BQDWN YYPhase 3 A@ . . .N. A12-15 YearsNAHrzDHr%PHrzDHr%P..Placebo Placebo .. YC4591001C4591001 1005 10051427DV100514271005AFWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAAP1-1RVVUHHVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1005SSWAB_WEEK4 NO Non-Important2021-03-11BQDWN YYPhase 3 A@ . . .N. A12-15 YearsNAHrzDHr%PHrzDHr%P..Placebo Placebo .. YC4591001C4591001 1005 10051442DV100514421005BFWHITE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1OSE3YZVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1005V2_VAX2_L NO Non-Important2021-01-13BDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr HrHr Hr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1005 10051447DV100514471005AFWHITE DWDW(BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1OS2TLKOther Informed Consent Informed Consent VACCINATION 1005Consent NO Non-Important2021-01-11ADW YYPhase 3 A@ . . .N. A12-15 YearsNAHr$`HrDHr$`HrD..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1005 10051447DV100514471005AFWHITE DWDW(BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA 1-1OS2TLQOther Informed Consent Informed Consent VACCINATION 1005Consent NO Non-Important2021-01-11ADW YYPhase 3 A@ . . .N. A12-15 YearsNAHr$`HrDHr$`HrD..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1005 10051448DV100514481005AFWHITE DWDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1OS2TM2Other Informed Consent Informed Consent VACCINATION 1005Consent NO Non-Important2021-01-11ADW YYPhase 3 A@ . . .N. A12-15 YearsNAHrCHrHrCHr..Placebo Placebo .. YC4591001C4591001 1005 10051451DV100514511005AFWHITE DWDW*BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1OTTAVCProcedure/Test not performed per protocol Procedures/Tests SCREENING 1005V1_DAY1_VAX1_L NO Non-Important2021-01-11DWYNYPhase 3 A@ . . .N. A12-15 YearsNAHrͪ`HrHrͪ`Hr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1006 10061001DV100610011006BBFWHITE DVuDW8Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1MI4EYNSerology sample collected at a visit where it is not required Laboratory VACCINATION 1006V2_VAX2_L NO Non-Important2020-08-25BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBBHq DHrHq DHrHrޑHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061001DV100610011006BBFWHITE DVuDW8Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1P8W7PNSite staff training missing/incomplete Other FOLLOW-UP 1006N/A NO Non-Important2020-11-18BiDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBBHq DHrHq DHrHrޑHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061001DV100610011006BBFWHITE DVuDW8Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1OT811NVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests FOLLOW-UP 1006V2_VAX2_L NO Non-Important2020-12-22BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBBHq DHrHq DHrHrޑHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061002DV100610021006BBMWHITE DVuDW8Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1MI4EYRSerology sample collected at a visit where it is not required Laboratory VACCINATION 1006V2_VAX2_L NO Non-Important2020-08-25BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBBHq HrHq HrHrޒXHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061003DV100610031006B8FWHITE DVyDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1LNDNHNNasal swab not collected for the visit where it is required Laboratory VACCINATION 1006POT_COVID_ILL NO Non-Important2020-08-13A@DV| YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB8HrHrlHrHrl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061003DV100610031006B8FWHITE DVyDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 1-1NB3NW0Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1006POT_COVID_CONVA NO Non-Important2020-09-18B(DV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB8HrHrlHrHrl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061005DV100610051006B#FASIAN DVyDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OH0NWLVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1006COVID_A1 NO Non-Important2020-12-28BDW YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB#Hr"Hr/Hr"HrHrHr/Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061008DV100610081006B1MWHITE DVyDW:Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1PAEE1QVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1006COVID_B1 NO Non-Important2021-02-05BDW, YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB1HrRHrsHrRHrHr%hHrsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061016DV100610161006BAMWHITE DVzDW>Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1SMY983Visit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1006V102_VAX4 NO Non-Important2021-02-23BDW> YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBAHrHsHrHrHr$HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061022DV100610221006B-MWHITE DV{DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OTT7KDSubject was unblinded for placebo transition and vaccinated despite being not eligible per protocol Other REPEAT SCREENING 1 1006Potential ReVax Initial Contact NO Non-Important2020-12-18BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB-HrHr@HrHrXHrѸHr@Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061024DV100610241006B,FWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1N8J6M8Visit not done Visit Schedule VACCINATION 1006Unplanned NO Non-Important2020-09-01BDV YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB,HrHr/HrHr/..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061024DV100610241006B,FWHITE DV{DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1OH0NWOVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006COVID_B1 NO Non-Important2021-01-04BDW YYPhase 3_ds6000 A0 . . .YA 18-55 Years. NB,HrHr/HrHr/..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061025DV100610251006BAFWHITE DV{DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1NH1B31Subject received the season influenza vaccine or the pandemic influenza vaccine within 14 days prior to or 14 days after the administration of IP. Concomitant MedicationsVACCINATION 1006V2_VAX2_L NO Non-Important2020-09-14B"DV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBAHr0HrȂ`Hr0HrrHrHrȂ`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061025DV100610251006BAFWHITE DV{DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1OW9I8BOther IP deviation Investigational ProductREPEAT SCREENING 1 1006Potential ReVax Initial Contact NO Non-Important2020-12-16BDV YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBAHr0HrȂ`Hr0HrrHrHrȂ`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061030DV100610301006BFMWHITE DV|DW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1OUFVX7Visit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1006COVID_A1 NO Non-Important2021-01-25BDW! YYPhase 3_ds6000 A0 . . .NA0>55 Years . NBFHrm HrpHrm Hr Hr9THrpPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061034DV100610341006BDMWHITE DV}DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1NK3N9ZVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-08B8DV YYPhase 3_ds6000 A0 . . .YA0>55 Years . NBDHr]HrȴHr]Hrȴ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061035DV100610351006B>FWHITE DV}DVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1PFF40YProcedure not performed as part of vital signs. Procedures/Tests REPEAT SCREENING 1 1006COVID_A1 NO Non-Important2021-02-10BDW1 YYPhase 3_ds6000 A0 . . .YA0>55 Years . NB>HrfHr"K HrfHr"K ..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW/ YC4591001C4591001 1006 10061037DV100610371006B3MWHITE DV}DW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NF7SG1Visit not done Visit Schedule VACCINATION 1006Unplanned NO Non-Important2020-09-05BDV YYPhase 3_ds6000 A0 . . .NA 18-55 Years. NB3HrPHsHrPHr"+Hr$HsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW! YC4591001C4591001 1006 10061040DV100610401006BFWHITE DV}DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1NUXWAPPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006POT_COVID_ILL NO Non-Important2020-09-20B&DV YYPhase 3 A@ . . .NA 18-55 Years. NBHr̜HrYHr̜Hr"rDHr HrYPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061040DV100610401006BFWHITE DV}DWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NKLJ9ENasal swab not collected for the visit where it is required Laboratory VACCINATION 1006POT_COVID_ILL NO Non-Important2020-09-23B)DV YYPhase 3 A@ . . .NA 18-55 Years. NBHr̜HrYHr̜Hr"rDHr HrYPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061043DV100610431006BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NDY34RVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-11BDV YYPhase 3 A@ . . .YA 18-55 YearsA 16-25 YearsNBHr THr*#Hr THr*#..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1006 10061044DV100610441006B?FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1NNNFIZSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsVACCINATION 1006V2_VAX2_L NO Non-Important2020-09-22B%DV YYPhase 3 A@ . . .YA0>55 Years . NB?Hr jHr(Hr jHr(..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW" YC4591001C4591001 1006 10061046DV100610461006BCFWHITE DVDW/Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1OTC7Q1Procedure not performed as part of vital signs. Procedures/Tests OPEN LABEL TREATMENT1006V101_VAX3 NO Non-Important2021-01-20BDW YYPhase 3 A@ . . .NA0>55 Years . NBCHr tHrHr tHr'DHr@HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061052DV100610521006B$MWHITE DVDWLPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1NZMJXRPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006POT_COVID_CONVA NO Non-Important2020-08-31ADV YYPhase 3 A@ . . .NA 18-55 Years. NB$Hr lHs<Hr lHr'bHr@4Hs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW/ YC4591001C4591001 1006 10061052DV100610521006B$MWHITE DVDWLPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NO3W5DNasal swab not collected for the visit where it is required Laboratory VACCINATION 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-09-23B%DV YYPhase 3 A@ . . .NA 18-55 Years. NB$Hr lHs<Hr lHr'bHr@4Hs<Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW/ YC4591001C4591001 1006 10061056DV100610561006BMWHITE DVDW!Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OQ5JY3Procedure/Test not performed per protocol Procedures/Tests REPEAT SCREENING 1 1006Potential ReVax Initial Contact NO Non-Important2020-12-29BDW YYPhase 3 A@ . . .NA 18-55 Years. NBHr pHrHr pHr'xHr'HrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061066DV100610661006B'FWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1N8NMXVVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-14BDV YYPhase 3 A@ . . .NA 18-55 Years. NB'Hr HrŒHr Hr/]HrapHrŒPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061070DV100610701006B!MMULTIPLE DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1NUUK5LVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-10-02B-DV YYPhase 3 A@ . . .NA 18-55 Years. NB!Hr :(Hsd4Hr :(HrGHr]Hsd4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1006 10061070DV100610701006B!MMULTIPLE DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1R0YDKRNasal swab not collected for the visit where it is required Laboratory OPEN LABEL TREATMENT1006COVID_B NO Non-Important2021-02-03BDW* YYPhase 3 A@ . . .NA 18-55 Years. NB!Hr :(Hsd4Hr :(HrGHr]Hsd4Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1006 10061071DV100610711006BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1N98E2JVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-15BDV YYPhase 3 A@ . . .YA 18-55 YearsA 16-25 YearsNBHr 9Hr0DHr 9Hr0D..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1006 10061074DV100610741006BFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NV7CQRVisit not done Visit Schedule VACCINATION 1006POT_COVID_CONVA|626381545454074 NO Non-Important2020-09-24B%DV YYPhase 3 A@ . . .YA 18-55 Years. NBHr YHr*ZHr YHr*Z..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW/ YC4591001C4591001 1006 10061075DV100610751006B*FWHITE DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124585601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-08-20ADV YYPhase 3 A@ . . .NA 18-55 Years. NB*Hr7 Hr( Hr7 Hr( ..Placebo Placebo .DW* YC4591001C4591001 1006 10061078DV100610781006B0FASIAN DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1R534IXReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1006V2_VAX2_L YES-POP2,YES-POP3 Important 2020-12-23B~DW YYPhase 3 A@ . . .NA 18-55 Years. NB0HrfdHr*HrfdHr*..Placebo Placebo .DV YC4591001C4591001 1006 10061078DV100610781006B0FASIAN DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1R534J1Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsREPEAT SCREENING 1 1006V2_VAX2_L YES-POP2,YES-POP3 Important 2021-01-13BDW YYPhase 3 A@ . . .NA 18-55 Years. NB0HrfdHr*HrfdHr*..Placebo Placebo .DV YC4591001C4591001 1006 10061079DV100610791006B/FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NDY34UVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-17BDV YYPhase 3 A@ . . .YA 18-55 Years. NB/Hr}\Hr1Hr}\Hr1..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061079DV100610791006B/FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1OT46Z3Urine pregnancy test not performed. Laboratory FOLLOW-UP 1006V2_VAX2_L NO Non-Important2020-10-15B9DV YYPhase 3 A@ . . .YA 18-55 Years. NB/Hr}\Hr1Hr}\Hr1..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061079DV100610791006B/FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A01-1NQNKATVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006POT_COVID_CONVA NO Non-Important2020-10-22B@DV YYPhase 3 A@ . . .YA 18-55 Years. NB/Hr}\Hr1Hr}\Hr1..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061082DV100610821006B@MWHITE DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1NK3NJTVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-06B0DV YYPhase 3 A@ . . .NA0>55 Years . NB@HrHsiHrHr(Hr[tHsiPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1006 10061084DV100610841006BFWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124400701IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-08-20ADV YYPhase 3 A@ . . .NA 18-55 Years. NBHr HrkHr Hr*SLHr֣HrkPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061084DV100610841006BFWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1NRDOHTPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006POT_COVID_ILL NO Non-Important2020-09-03ADV YYPhase 3 A@ . . .NA 18-55 Years. NBHr HrkHr Hr*SLHr֣HrkPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061087DV100610871006BJFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..>55 Years APA1-1MIBFE5Procedure/Test not done Procedures/Tests SCREENING 1006V1_DAY1_VAX1_L NO Non-Important2020-08-24.DV NNPhase 3 A@ . . .NA0>55 Years . NBJ...... .. NC4591001C4591001 1006 10061088DV100610881006BFWHITE DVDW?Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125558001IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-08-21ADV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHrHs-HrHr+dHr2Hs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW* YC4591001C4591001 1006 10061088DV100610881006BFWHITE DVDW?Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1NRDOHWPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006COVID_ILL NO Non-Important2020-08-29ADV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHrHs-HrHr+dHr2Hs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW* YC4591001C4591001 1006 10061088DV100610881006BFWHITE DVDW?Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1OSP6XDNasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1006COVID_A NO Non-Important2020-12-01BgDV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHrHs-HrHr+dHr2Hs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW* YC4591001C4591001 1006 10061090DV100610901006B"FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NRDOHZPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-09-18BDV YYPhase 3 A@ . . .YA 18-55 Years. NB"HrHr+,HrHr+,..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061093DV100610931006B"MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NRDOI2Potential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-08-31ADV YYPhase 3 A@ . . .YA 18-55 Years. NB"HrHr4`HrHr4`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1006 10061093DV100610931006B"MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NDY34XVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-18BDV YYPhase 3 A@ . . .YA 18-55 Years. NB"HrHr4`HrHr4`..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1006 10061094DV100610941006B#FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NZMJXVPotential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006POT_COVID_ILL NO Non-Important2020-08-31ADV YYPhase 3 A@ . . .YA 18-55 Years. NB#HrHr4HrHr4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW, YC4591001C4591001 1006 10061094DV100610941006B#FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NC2857Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-18BDV YYPhase 3 A@ . . .YA 18-55 Years. NB#HrHr4HrHr4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW, YC4591001C4591001 1006 10061095DV100610951006BFWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A125331201IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1006Vax 1 NO Non-Important2020-08-23DVYNYPhase 3 A@ . . .NA 18-55 Years. NBHrHHr_,HrHHr0xHrNHHr_,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061095DV100610951006BFWHITE DVDW0Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1OUFVXBVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1006COVID_A1 NO Non-Important2021-01-20BDW YYPhase 3 A@ . . .NA 18-55 Years. NBHrHHr_,HrHHr0xHrNHHr_,Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061097DV100610971006BAMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 1-1NRDOI5Potential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006POT_COVID_ILL NO Non-Important2020-09-08BDV YYPhase 3 A@ . . .YA0>55 Years . NBAHr Hr0(Hr Hr0(..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW! YC4591001C4591001 1006 10061097DV100610971006BAMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1T8K0XFNasal swab not collected for the visit where it is required Laboratory FOLLOW-UP 1006COVID_B NO Non-Important2020-10-19B9DV YYPhase 3 A@ . . .YA0>55 Years . NBAHr Hr0(Hr Hr0(..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW! YC4591001C4591001 1006 10061099DV100610991006BMWHITE DVDWNPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1N8RICJParticipant met exclusion criterion #16 (Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation) Inclusion/Exclusion VACCINATION 1006V1_DAY1_VAX1_L YES-POP2,YES-POP3 Important 2020-08-24ADV YYPhase 3 A@ . . .NA 18-55 Years. NBHrHs8HrHr0HrxHs8Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW0 YC4591001C4591001 1006 10061101DV100611011006B9MWHITE DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1NO3W5HNasal swab not collected for the visit where it is required Laboratory VACCINATION 1006COVID_B NO Non-Important2020-09-24B DV YYPhase 3 A@ . . .NA0>55 Years . NB9HrTHsPHrTHr/{HrHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1006 10061101DV100611011006B9MWHITE DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1RIGQN1Visit not done Visit Schedule FOLLOW-UP 1006COVID_C1 NO Non-Important2020-10-23B=DV YYPhase 3 A@ . . .NA0>55 Years . NB9HrTHsPHrTHr/{HrHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1006 10061101DV100611011006B9MWHITE DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA01-1P85LTVVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1006COVID_E1 NO Non-Important2021-02-03BDW* YYPhase 3 A@ . . .NA0>55 Years . NB9HrTHsPHrTHr/{HrHsPPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1006 10061102DV100611021006B*FWHITE DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NC4ZJOProcedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-14BDV YYPhase 3 A@ . . .NA 18-55 Years. NB*HrHsͬHrHr/`HsͬHsͬPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1006 10061103DV100611031006B(MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NC4ZJ7Procedure not recorded in source documentation as having been performed. Procedures/Tests VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-14BDV YYPhase 3 A@ . . .YA 18-55 Years. NB(Hr`Hr/Hr`Hr/..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061105DV100611051006B:FWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1SMY987Visit performed outside of protocol specified window. Visit Schedule OPEN LABEL FOLLOW-UP1006V103_MONTH1 NO Non-Important2021-02-19BDW: YYPhase 3 A@ . . .NA0>55 Years . NB:Hr<Hr͚Hr<Hr18HrNlHr͚Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061108DV100611081006B#FAMERICAN INDIAN OR ALASKA NATIVE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NO38N8Nasal swab not collected for the visit where it is required Laboratory VACCINATION 1006POT_COVID_ILL NO Non-Important2020-09-16BDV YYPhase 3 A@ . . .YA 18-55 Years. NB#HrDHr4yHrDHr4y..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061108DV100611081006B#FAMERICAN INDIAN OR ALASKA NATIVE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NDY350Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-18BDV YYPhase 3 A@ . . .YA 18-55 Years. NB#HrDHr4yHrDHr4y..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061108DV100611081006B#FAMERICAN INDIAN OR ALASKA NATIVE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A01-1NRA4GHVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006POT_COVID_CONVA NO Non-Important2020-10-22B;DV YYPhase 3 A@ . . .YA 18-55 Years. NB#HrDHr4yHrDHr4y..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061109DV100611091006B$MWHITE DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1PFF3OMReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsFOLLOW-UP 1006V2_VAX2_L YES-POP2,YES-POP3 Important 2021-01-06BDW YYPhase 3 A@ . . .NA 18-55 Years. NB$Hr&Hr/lHr&Hr/l..Placebo Placebo .DW/ YC4591001C4591001 1006 10061109DV100611091006B$MWHITE DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1PFF3OJReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsFOLLOW-UP 1006V2_VAX2_L YES-POP2,YES-POP3 Important 2021-02-03BDW* YYPhase 3 A@ . . .NA 18-55 Years. NB$Hr&Hr/lHr&Hr/l..Placebo Placebo .DW/ YC4591001C4591001 1006 10061113DV100611131006BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NBMAC8Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-21BDV YYPhase 3 A@ . . .YA 18-55 Years. NBHr3DHr8PPHr3DHr8PP..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW) YC4591001C4591001 1006 10061115DV100611151006B=FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1O38VUCVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006COVID_A1 NO Non-Important2020-11-23BZDV YYPhase 3 A@ . . .YA0>55 Years . NB=HrHr2.HrHr2...BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061115DV100611151006B=FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA 1-1OWH8XBVisit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1006COVID_B1 NO Non-Important2021-01-28BDW$ YYPhase 3 A@ . . .YA0>55 Years . NB=HrHr2.HrHr2...BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061122DV100611221006B'MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NO392NNasal swab not collected for the visit where it is required Laboratory VACCINATION 1006COVID_A NO Non-Important2020-09-14BDV YYPhase 3 A@ . . .YA 18-55 Years. NB'Hr֐Hr4Hr֐Hr4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1006 10061122DV100611221006B'MWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1NRA4GKVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006POT_COVID_CONVA NO Non-Important2020-10-22B9DV YYPhase 3 A@ . . .YA 18-55 Years. NB'Hr֐Hr4Hr֐Hr4..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1006 10061124DV100611241006BFWHITE DVDWEPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NBMACGVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-09-21BDV YYPhase 3 A@ . . .NA 18-55 Years. NBHrTHs HrTHr8d<HrFHs Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW/ YC4591001C4591001 1006 10061131DV100611311006BMWHITE DVDWLPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1NRDOI8Potential COVID-19 illness visit not done when required per protocol. Visit Schedule VACCINATION 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-09-04ADV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHr2$Hs;Hr2$Hr4Hr0Hs;Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061131DV100611311006BMWHITE DVDWLPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1OH0NX4Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006COVID_A1 NO Non-Important2020-12-31B~DW YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHr2$Hs;Hr2$Hr4Hr0Hs;Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061134DV100611341006B2FWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1O05DFXVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-11-17BNDV YYPhase 3 A@ . . .YA 18-55 Years. NB2Hr(8Hr9|Hr(8Hr9|..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW, YC4591001C4591001 1006 10061140DV100611401006B$MASIAN DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1OH0NX7Visit performed outside of protocol specified window. Visit Schedule REPEAT SCREENING 1 1006COVID_B1 NO Non-Important2020-12-30BxDW YYPhase 3 A@ . . .YA 18-55 Years. NB$HrpHr9hHrpHr9h..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DV YC4591001C4591001 1006 10061146DV100611461006BCFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA>55 Years APA1-1NQOSUJVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-10-21B*DV YYPhase 3 A@ . . .NA0>55 Years . NBCHr*.HrC.Hr*.HrC...BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW* YC4591001C4591001 1006 10061147DV100611471006B;FWHITE DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1SKKCBKReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsFOLLOW-UP 1006Potential ReVax Initial Contact YES-POP2,YES-POP3 Important 2021-01-15BDW YYPhase 3 A@ . . .NA0>55 Years . NB;Hr*HHrEHr*HHrE..Placebo Placebo .DW/ YC4591001C4591001 1006 10061155DV100611551006BFWHITE DVDW>Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124403301IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-09-29ADV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrCU|Hs-HrCU|HraHs-Hs-Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW6 YC4591001C4591001 1006 10061159DV100611591006BFWHITE DVDWOPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124403201IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-09-24ADV YYPhase 3 A@ . . .NA 18-55 YearsA 16-25 YearsNBHrDV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr=,HrYlHr=,HrYl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW/ YC4591001C4591001 1006 10061162DV100611621006BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1O073MYLab performed out of window Laboratory FOLLOW-UP 1006COVID_A NO Non-Important2021-01-21BwDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr=,HrYlHr=,HrYl..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW/ YC4591001C4591001 1006 10061164DV100611641006BFWHITE DVDWEPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124403101IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-09-25ADV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr>(HsMHr>(HrXHrIHsMPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061167DV100611671006BFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A124402901IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-09-28ADV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrAHr]HrAHr]..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061169DV100611691006BMWHITE DVDW6Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124402801IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-10-02ADV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrG]pHr0HrG]pHrc hHrwHr0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061169DV100611691006BMWHITE DVDW6Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1OVP283Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006COVID_A1 NO Non-Important2020-12-08BDDV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrG]pHr0HrG]pHrc hHrwHr0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061169DV100611691006BMWHITE DVDW6Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1QRF9ZLAssessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests OPEN LABEL TREATMENT1006V101_VAX3 NO Non-Important2021-01-27BvDW# YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrG]pHr0HrG]pHrc hHrwHr0Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061170DV100611701006BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 124402601IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-10-05ADV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrKJHriHrKJHri..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW9 YC4591001C4591001 1006 10061170DV100611701006BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NVQ3MISubject/LAR signed a superseded/outdated version of the ICD Informed Consent VACCINATION 1006Consent NO Non-Important2020-10-28BDV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrKJHriHrKJHri..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW9 YC4591001C4591001 1006 10061171DV100611711006BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 124402501IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-10-08ADV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrOJ0HrhLHrOJ0HrhL..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061171DV100611711006BMWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1NVPQANOther Informed Consent Informed Consent VACCINATION 1006Consent NO Non-Important2020-10-27BDV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrOJ0HrhLHrOJ0HrhL..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061173DV100611731006BFNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERDVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A124402401IP documentation error IRT Confirmation Report error Investigational ProductVACCINATION 1006Vax 1 NO Non-Important2020-10-09ADV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrPyHrl(HrPyHrl(..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061174DV100611741006BMAMERICAN INDIAN OR ALASKA NATIVE DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124888101IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1006Vax 1 NO Non-Important2020-10-11DVYNYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrTHroƄHrTHroƄ..Placebo Placebo .DW= YC4591001C4591001 1006 10061176DV100611761006BFWHITE DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A124888001IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1006Vax 1 NO Non-Important2020-10-26DVYNYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrhWdHrHrhWdHr..Placebo Placebo .DW* YC4591001C4591001 1006 10061176DV100611761006BFWHITE DVDVPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1OX5PKFVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006V3_MONTH1_POSTVAX2_L NO Non-Important2020-12-29B@DW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrhWdHrHrhWdHr..Placebo Placebo .DW* YC4591001C4591001 1006 10061178DV100611781006BNMBLACK OR AFRICAN AMERICAN DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA1-1O4AHN7Visit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-11-20BDV YYPhase 3 A@ . . .NA0>55 Years . NBNHrfHsfHrfHrƨHrHsfPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061178DV100611781006BNMBLACK OR AFRICAN AMERICAN DVDW=Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA>55 Years APA 1-1SMY996Visit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1006V102_VAX4 NO Non-Important2021-02-22BxDW= YYPhase 3 A@ . . .NA0>55 Years . NBNHrfHsfHrfHrƨHrHsfPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1006 10061180DV100611801006BFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A124887901IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1006Vax 1 NO Non-Important2020-11-05DVYNYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHruqHr>HruqHr>..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061180DV100611801006BFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 125331401IP documentation error IRT Confirmation Report error Investigational ProductSCREENING 1006Vax 1 NO Non-Important2020-11-05DVYNYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHruqHr>HruqHr>..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061180DV100611801006BFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A01-1ORCDBDVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006V3_MONTH1_POSTVAX2_L NO Non-Important2021-01-04B<DW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHruqHr>HruqHr>..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061182DV100611821006BMMULTIPLE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1OT811EVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1006V2_VAX2_L NO Non-Important2021-01-07B'DW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrtHrHrtHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1006 10061182DV100611821006BMMULTIPLE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A 1-1ORCDBHVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2021-01-07B'DW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrtHrHrtHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW+ YC4591001C4591001 1006 10061183DV100611831006AMMULTIPLE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA 1-1OT811HVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1006V2_VAX2_L NO Non-Important2021-01-07B'DW YYPhase 3 A@ . . .N. A12-15 YearsNAHrHr̐HrHr̐..Placebo Placebo .. YC4591001C4591001 1006 10061183DV100611831006AMMULTIPLE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA01-1OS305PVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2021-01-07B'DW YYPhase 3 A@ . . .N. A12-15 YearsNAHrHr̐HrHr̐..Placebo Placebo .. YC4591001C4591001 1006 10061183DV100611831006AMMULTIPLE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1POJ18NProcedure/Test not performed per protocol Procedures/Tests FOLLOW-UP 1006V3_MONTH1_POSTVAX2_L NO Non-Important2021-02-09BHDW0 YYPhase 3 A@ . . .N. A12-15 YearsNAHrHr̐HrHr̐..Placebo Placebo .. YC4591001C4591001 1006 10061185DV100611851006BFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1PE2KY8Nasal swab not collected for the visit where it is required Laboratory VACCINATION 1006COVID_A NO Non-Important2020-12-30BDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr# HrsHr# Hrs..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW1 YC4591001C4591001 1006 10061187DV100611871006BFWHITE DVDWFPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OT811KVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1006V2_VAX2_L NO Non-Important2020-12-28BDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrLHsHrLHr HsHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061187DV100611871006BFWHITE DVDWFPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1OS305TVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-12-28BDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrLHsHrLHr HsHsPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061203DV100612031006AFWHITE DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1OSO0CLVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1006V2_VAX2_L NO Non-Important2020-12-22BDV YYPhase 3 A@ . . .N. A12-15 YearsNAHrXHr׸HrXHr׸..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1006 10061215DV100612151006BMWHITE DVDW?Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1OLQQYKSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsVACCINATION 1006V1_DAY1_VAX1_L NO Non-Important2020-12-09A`DV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr_ Hs`Hr_ HrHs`Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061215DV100612151006BMWHITE DVDW?Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1PBRKS3Subject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsVACCINATION 1006V1_DAY1_VAX1_L NO Non-Important2020-12-09A`DV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr_ Hs`Hr_ HrHs`Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061215DV100612151006BMWHITE DVDW?Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A01-1PBRKVEOther Informed Consent Informed Consent VACCINATION 1006Consent NO Non-Important2020-12-23BDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr_ Hs`Hr_ HrHs`Hs`Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW2 YC4591001C4591001 1006 10061219DV100612191006AMWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1ORCDBKVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2020-12-24BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrtHrSHrtHrS..Placebo Placebo .. YC4591001C4591001 1006 10061230DV100612301006AFMULTIPLE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1OVP24TNasal swab not collected for the visit where it is required Laboratory VACCINATION 1006V2_VAX2_L NO Non-Important2020-12-31BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrpHr0HrpHr0..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1006 10061233DV100612331006AMWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1OT811QVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests VACCINATION 1006V2_VAX2_L NO Non-Important2020-12-29BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrHrgHrHrg..Placebo Placebo .. YC4591001C4591001 1006 10061240DV100612401006BFWHITE DVDW BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA16-55 YearsA A1-1ORCDILVisit performed outside of protocol specified window. Visit Schedule VACCINATION 1006V2_VAX2_L NO Non-Important2021-01-05BDW YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHrðHrnHrðHrn..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW8 YC4591001C4591001 1006 10061246DV100612461006BFWHITE DVDWKPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A1-1P3CH88Participant met exclusion criterion #01 (participant having other medical or psychiatric condition) Inclusion/Exclusion VACCINATION 1006V1_DAY1_VAX1_L YES-POP2,YES-POP3 Important 2020-12-10ADV YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr]HsN(Hr]Hr`HrGHHsN(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061246DV100612461006BFWHITE DVDWKPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA16-55 YearsA A 1-1PNQNFSVisit performed outside of protocol specified window. Visit Schedule OPEN LABEL TREATMENT1006COVID_A1 NO Non-Important2021-02-17BFDW8 YYPhase 3 A@ . . .NA16-17 YearsA 16-25 YearsNBHr]HsN(Hr]Hr`HrGHHsN(Placebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW7 YC4591001C4591001 1006 10061247DV100612471006AFWHITE DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1PAG6XISerology sample not collected Laboratory FOLLOW-UP 1006V3_MONTH1_POSTVAX2_L NO Non-Important2021-01-28B2DW$ YYPhase 3 A@ . . .N. A12-15 YearsNAHr^Hr`Hr^Hr`..Placebo Placebo .. YC4591001C4591001 1006 10061254DV100612541006AFWHITE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1P85LFLVisit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006COVID_A1 NO Non-Important2021-02-02B6DW) YYPhase 3 A@ . . .N. A12-15 YearsNAHrrHrHrrHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1006 10061267DV100612671006AFASIAN DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA1-1PG7JLHNasal swab not collected by site staff prior to vaccination. Laboratory VACCINATION 1006V2_VAX2_L NO Non-Important2021-01-06BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrHrڜHrHrڜ..Placebo Placebo .. YC4591001C4591001 1006 10061267DV100612671006AFASIAN DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA01-1PG76QCProcedure not performed as part of vital signs. Procedures/Tests VACCINATION 1006V2_VAX2_L NO Non-Important2021-01-06BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrHrڜHrHrڜ..Placebo Placebo .. YC4591001C4591001 1006 10061267DV100612671006AFASIAN DVDWPlacebo PLACEBO Placebo PLACEBO Placebo Placebo AA12-15 YearsAA 1-1QZSYM3Other lab deviation Laboratory VACCINATION 1006V2_VAX2_L NO Non-Important2021-01-22B'DW YYPhase 3 A@ . . .N. A12-15 YearsNAHrHrڜHrHrڜ..Placebo Placebo .. YC4591001C4591001 1006 10061269DV100612691006AMWHITE DVDWBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1PFF411Visit performed outside of protocol specified window. Visit Schedule FOLLOW-UP 1006COVID_A1 NO Non-Important2021-02-10B:DW1 YYPhase 3 A@ . . .N. A12-15 YearsNAHrHrHrHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1006 10061272DV100612721006AFBLACK OR AFRICAN AMERICAN DVDVBNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1OXOQ5YParticipant met exclusion criterion #01 (participant having other medical or psychiatric condition) Inclusion/Exclusion VACCINATION 1006V1_DAY1_VAX1_L YES-POP2,YES-POP3 Important 2020-12-16ADV YYPhase 3 A@ . . .N. A12-15 YearsNAHrHrHrHr..BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1006 10061278DV100612781006AMWHITE DVDW BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) B2_P23_30BNT162b2 Phase 2/3 (30 mcg) BNT162b2 Phase 2/3 (30 mcg) AA12-15 YearsAA1-1R1DHHZNasal swab not collected for the visit where it is required Laboratory VACCINATION 1006COVID_A NO Non-Important2021-01-04BDW YYPhase 3 A@ . . .N. A12-15 YearsNAHrHrOHrHrO..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .. YC4591001C4591001 1007 10071001DV100710011007BFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A 1-1KRCQTLProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071001DV100710011007BFWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1N8K5KJProcedure not performed as part of vital signs. Procedures/Tests SCREENING 1007UNPL NO Non-Important2020-08-06.DVu NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071002DV100710021007BFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRFTB5Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071003DV100710031007BFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRFTB8Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071004DV100710041007BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRFTBBProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071005DV100710051007BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRFTBEProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071006DV100710061007B5FBLACK OR AFRICAN AMERICAN ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRFTBMProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB5...... .. NC4591001C4591001 1007 10071007DV100710071007BFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRFTBZProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071008DV100710081007BMWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRFTC2Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071009DV100710091007B FWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KRF4G3Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-04.DV NNPhase 1 A . . .NA 18-55 Years. NB ...... .. NC4591001C4591001 1007 10071010DV100710101007BMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KRF4G6Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071011DV100710111007B'FWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRF4G9Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB'...... .. NC4591001C4591001 1007 10071012DV100710121007BFWHITE ..NOT ASSIGNED NOTASSGN NOT ASSIGNED NOTASSGN ..18-55 YearsA0A1-1KRF4GCProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-05-06.DV NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071013DV100710131007B%FWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KRF4GFProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-02.DV4 NNPhase 1 A . . .NA 18-55 Years. NB%...... .. NC4591001C4591001 1007 10071014DV100710141007B2MWHITE DV=DVQBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1KRF4GIProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-02DV4YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB2HqF,HqXHqF,HqX..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071015DV100710151007B5MWHITE DV:DVOBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KRF4GLProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-02`DV4YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB5Hq HqHq Hq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071015DV100710151007B5MWHITE DV:DVOBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1R1DGH9Other Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-13BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB5Hq HqHq Hq..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071016DV100710161007BFASIAN DV<DVQBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KRF4GOProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-02DV4YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHHqfLHqHHqfL..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071016DV100710161007BFASIAN DV<DVQBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1R1DGJAOther Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-10BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHHqfLHqHHqfL..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071017DV100710171007B*FWHITE DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1KRF4GRProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-02DV4YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB*HqD8HqHqD8Hq..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071018DV100710181007B/MASIAN ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KRF4GUProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-02.DV4 NNPhase 1 A . . .NA 18-55 Years. NB/...... .. NC4591001C4591001 1007 10071019DV100710191007BFWHITE DV:DVOBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KRF4GXProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03PDV5YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq,HqɷHq,Hqɷ..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071019DV100710191007BFWHITE DV:DVOBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1R1DGNJOther Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-10BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHq,HqɷHq,Hqɷ..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071020DV100710201007BMWHITE DV<DW*Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1KRF4H0Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03pDV5YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQPlacebo A`Placebo A`NA 18-55 Years. NBHqДHrHqДHq̃HrHrPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071021DV100710211007B'FWHITE DV<DVQBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KRF4H3Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03pDV5YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB'HqHqZXHqHqZX..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071021DV100710211007B'FWHITE DV<DVQBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1R1JVG3Other Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-11BDV YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NB'HqHqZXHqHqZX..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071022DV100710221007BFWHITE DV<DVQBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A01-1KRF4H6Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03pDV5YNYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqgHqHqg..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071022DV100710221007BFWHITE DV<DVQBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A 1-1KZNLVPProcedure not performed as part of vital signs. Procedures/Tests VACCINATION 1007V2_DAY2_POSTVAX1_S NO Non-Important2020-06-12A0DV> YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqgHqHqg..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071022DV100710221007BFWHITE DV<DVQBNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) B2_10 BNT162b2 Phase 1 (10 mcg) BNT162b2 Phase 1 (10 mcg) APAP18-55 YearsA0A1-1R1JVGOOther Informed Consent Informed Consent REPEAT SCREENING 1 1007Consent NO Non-Important2021-01-21BDW YYPhase 1 AStage 1, Age 18 to 55, Low dose level (10mcg), 21 Day (BNT162b2 or PBO) AQ10 (*ESC*){unicode 03BC}g A10 (*ESC*){unicode 03BC}g ANA 18-55 Years. NBHqHqgHqHqg..BNT162b2 (10 (*ESC*){unicode 03BC}g) BNT162b2 (10 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071023DV100710231007BFWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1KRF4H9Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03DV5YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NBHqPHqՉHqPHqՉ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071023DV100710231007BFWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1R1JVH9Other Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-10BDV YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NBHqPHqՉHqPHqՉ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071024DV100710241007BMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KRF4HCProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03.DV5 NNPhase 1 A . . .NA 18-55 Years. NB...... .. NC4591001C4591001 1007 10071025DV100710251007BFWHITE DVCDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A01-1KRF4HFProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03DV5YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NBHqTHrxHqTHqկHrDHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071025DV100710251007BFWHITE DVCDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A1-1R1JVJ5Other Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-10BDV YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NBHqTHrxHqTHqկHrDHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071025DV100710251007BFWHITE DVCDW(Placebo PLACEBO Placebo PLACEBO Placebo Placebo AA18-55 YearsA0A 126924601IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductREPEAT SCREENING 1 1007Vax 3 NO Non-Important2021-01-10BDW YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)APlacebo A`Placebo A`NA 18-55 Years. NBHqTHrxHqTHqկHrDHrxPlacebo Placebo BNT162b2 (30 (*ESC*){unicode 03BC}g)BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071026DV100710261007B5FBLACK OR AFRICAN AMERICAN DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A01-1KRF4HIProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03DV5YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB5HqEHqHqEHq..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071026DV100710261007B5FBLACK OR AFRICAN AMERICAN DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1L4DX62Subject/LAR signed a superseded/outdated version of the ICD Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-07-21B%DVe YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB5HqEHqHqEHq..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071026DV100710261007B5FBLACK OR AFRICAN AMERICAN DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1R1JVK6Other Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-14BDV YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB5HqEHqHqEHq..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071027DV100710271007BMWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A 1-1KRF4HLProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03DV5YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NBHqpHqաDHqpHqաD..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071027DV100710271007BMWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1R1JVKHOther Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-10BDV YYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NBHqpHqաDHqpHqաD..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071028DV100710281007B/MASIAN ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..18-55 YearsA0A1-1KRF4HOProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03.DV5 NNPhase 1 A . . .NA 18-55 Years. NB/...... .. NC4591001C4591001 1007 10071029DV100710291007B'MWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`18-55 YearsA0A1-1KRF4HRProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-03DV5YNYPhase 1 AStage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA 18-55 Years. NB'HqHq՜HqHq՜..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071030DV100710301007BGMWHITE ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KRF4HXProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-08.DV: NNPhase 1 A . . .NA0>55 Years . NBG...... .. NC4591001C4591001 1007 10071031DV100710311007BMMWHITE DVCDVXBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A1-1KRF4I0Procedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-08DV:YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBMHq HqՖHq HqՖ..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071032DV100710321007BDMWHITE DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A 1-1KRF4IDProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-08pDV:YNYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBDHqKHqHqKHq..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071032DV100710321007BDMWHITE DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A1-1R1JVLROther Informed Consent Informed Consent FOLLOW-UP 1007Consent NO Non-Important2020-12-10BDV YYPhase 1 AStage 1, Age 65 to 85, Low-Mid dose level (20mcg), 21 Day (BNT162b2 or PBO)A20 (*ESC*){unicode 03BC}g A 20 (*ESC*){unicode 03BC}g A NA0>55 Years . NBDHqKHqHqKHq..BNT162b2 (20 (*ESC*){unicode 03BC}g) BNT162b2 (20 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071033DV100710331007BCFASIAN ..SCREEN FAILURE SCRNFAIL SCREEN FAILURE SCRNFAIL ..65-85 YearsA@A1-1KRF4IGProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-08.DV: NNPhase 1 A . . .NA0>55 Years . NBC...... .. NC4591001C4591001 1007 10071034DV100710341007BEFWHITE DVADVVBNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) B2_30 BNT162b2 Phase 1 (30 mcg) BNT162b2 Phase 1 (30 mcg) ApAp65-85 YearsA@A1-1KRF4IJProcedure/Test not done Procedures/Tests SCREENING 1007SCR NO Non-Important2020-06-08pDV:YNYPhase 1 AStage 1, Age 65 to 85, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO) AzG30 (*ESC*){unicode 03BC}g A030 (*ESC*){unicode 03BC}g A0NA0>55 Years . NBEHqYHqHqYHq..BNT162b2 (30 (*ESC*){unicode 03BC}g) BNT162b2 (30 (*ESC*){unicode 03BC}g) .DW YC4591001C4591001 1007 10071035DV100710351007BQFWHITE DVADVVBNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) B2_20 BNT162b2 Phase 1 (20 mcg) BNT162b2 Phase 1 (20 mcg) A`A`65-85 YearsA@A 1-1KRF4IM