HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 X64_SR12 18JUN21:06:47:1618JUN21:06:47:16 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS DV SASDATA 9.4 X64_SR12 18JUN21:06:47:1618JUN21:06:47:16 Protocol Deviations HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000001100000000000000000000 STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier SUBJID Subject Identifier for the Study )DVSEQ Sequence Number 2ÇDVTERM Protocol Deviation Term :DVCAT Category for Protocol Deviation DVSCAT Subcategory for Protocol Deviation EPOCH Epoch 1 DVSTDTC Start Date/Time of Deviation EDVSTDY Study Day of Start of Deviation O HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P201DVmRNA-1273-P201-US201-1004US2011004AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BzmRNA-1273-P201DVmRNA-1273-P201-US201-1004US2011004A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-05C`mRNA-1273-P201DVmRNA-1273-P201-US201-1004US2011004A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1007US2011007AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1009US2011009AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-28BxmRNA-1273-P201DVmRNA-1273-P201-US201-1009US2011009A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1011US2011011AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US201-1011US2011011A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-27B[mRNA-1273-P201DVmRNA-1273-P201-US201-1011US2011011A0P09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) Protocol DeviationConcomitant Medication PART A FOLLOW-UP 2021-03-04C€mRNA-1273-P201DVmRNA-1273-P201-US201-1011US2011011A@P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-11BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1012US2011012AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BymRNA-1273-P201DVmRNA-1273-P201-US201-1012US2011012A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1012US2011012A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-19C€mRNA-1273-P201DVmRNA-1273-P201-US201-1014US2011014AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-01B{mRNA-1273-P201DVmRNA-1273-P201-US201-1014US2011014A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1018US2011018AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BzmRNA-1273-P201DVmRNA-1273-P201-US201-1018US2011018A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1018US2011018A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-25CàmRNA-1273-P201DVmRNA-1273-P201-US201-1019US2011019AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BxmRNA-1273-P201DVmRNA-1273-P201-US201-1019US2011019A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1020US2011020AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BzmRNA-1273-P201DVmRNA-1273-P201-US201-1020US2011020A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1023US2011023AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1028US2011028AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-24CÐmRNA-1273-P201DVmRNA-1273-P201-US201-1028US2011028A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1029US2011029AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-28BxmRNA-1273-P201DVmRNA-1273-P201-US201-1029US2011029A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1030US2011030AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1032US2011032AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BxmRNA-1273-P201DVmRNA-1273-P201-US201-1032US2011032A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-05CPmRNA-1273-P201DVmRNA-1273-P201-US201-1032US2011032A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1039US2011039AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1040US2011040AP05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-06-29BmRNA-1273-P201DVmRNA-1273-P201-US201-1040US2011040A P09.1 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (IMMUNOSUPPRESSANTS OR OTHER IMMUNE-MODIFYING DRUGS ADMINISTERED CHRONICALLY (IE, MORE THAN 14 DAYS IN TOTAL) DURING THE STUDY PERIOD. FOR Protocol DeviationConcomitant Medication PART A FOLLOW-UP 2021-01-26BðmRNA-1273-P201DVmRNA-1273-P201-US201-1040US2011040A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1041US2011041AP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationMissing Endpoint Assessments PART A FOLLOW-UP 2020-12-29BÓmRNA-1273-P201DVmRNA-1273-P201-US201-1041US2011041A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-10AmRNA-1273-P201DVmRNA-1273-P201-US201-1041US2011041A0P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US201-1041US2011041A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-26B“mRNA-1273-P201DVmRNA-1273-P201-US201-1041US2011041APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-04C@mRNA-1273-P201DVmRNA-1273-P201-US201-1041US2011041A`P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1042US2011042AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-13B$mRNA-1273-P201DVmRNA-1273-P201-US201-1042US2011042A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-21BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1043US2011043AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-28BxmRNA-1273-P201DVmRNA-1273-P201-US201-1043US2011043A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1046US2011046AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-01BzmRNA-1273-P201DVmRNA-1273-P201-US201-1046US2011046A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1046US2011046A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-23BìmRNA-1273-P201DVmRNA-1273-P201-US201-1048US2011048AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-02B^mRNA-1273-P201DVmRNA-1273-P201-US201-1048US2011048A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1048US2011048A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-22BìmRNA-1273-P201DVmRNA-1273-P201-US201-1048US2011048A@P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-19C€mRNA-1273-P201DVmRNA-1273-P201-US201-1050US2011050AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1050US2011050A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-22BìmRNA-1273-P201DVmRNA-1273-P201-US201-1050US2011050A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-19C€mRNA-1273-P201DVmRNA-1273-P201-US201-1051US2011051AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-01B\mRNA-1273-P201DVmRNA-1273-P201-US201-1051US2011051A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-12B…mRNA-1273-P201DVmRNA-1273-P201-US201-1051US2011051A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-01BõmRNA-1273-P201DVmRNA-1273-P201-US201-1051US2011051A@P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1055US2011055AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US201-1055US2011055A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1056US2011056AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1057US2011057AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-17BÇmRNA-1273-P201DVmRNA-1273-P201-US201-1059US2011059AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-30BmRNA-1273-P201DVmRNA-1273-P201-US201-1059US2011059A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BymRNA-1273-P201DVmRNA-1273-P201-US201-1059US2011059A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1060US2011060AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-28BwmRNA-1273-P201DVmRNA-1273-P201-US201-1060US2011060A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-17BÇmRNA-1273-P201DVmRNA-1273-P201-US201-1061US2011061AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÇmRNA-1273-P201DVmRNA-1273-P201-US201-1064US2011064AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-28BwmRNA-1273-P201DVmRNA-1273-P201-US201-1064US2011064A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1065US2011065AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BxmRNA-1273-P201DVmRNA-1273-P201-US201-1065US2011065A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1067US2011067AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-27B“mRNA-1273-P201DVmRNA-1273-P201-US201-1067US2011067A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-29BwmRNA-1273-P201DVmRNA-1273-P201-US201-1067US2011067A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-16BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1067US2011067A@P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-10A€mRNA-1273-P201DVmRNA-1273-P201-US201-1068US2011068AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÈmRNA-1273-P201DVmRNA-1273-P201-US201-1069US2011069AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-01BzmRNA-1273-P201DVmRNA-1273-P201-US201-1069US2011069A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÈmRNA-1273-P201DVmRNA-1273-P201-US201-1070US2011070AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-10A`mRNA-1273-P201DVmRNA-1273-P201-US201-1070US2011070A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-12A€mRNA-1273-P201DVmRNA-1273-P201-US201-1070US2011070A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling 2020-09-03B[mRNA-1273-P201DVmRNA-1273-P201-US201-1070US2011070A@P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-12A€mRNA-1273-P201DVmRNA-1273-P201-US201-1080US2011080AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-29BñmRNA-1273-P201DVmRNA-1273-P201-US201-1080US2011080A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-02CmRNA-1273-P201DVmRNA-1273-P201-US201-1080US2011080A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÇmRNA-1273-P201DVmRNA-1273-P201-US201-1084US2011084AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-09BÞmRNA-1273-P201DVmRNA-1273-P201-US201-1085US2011085AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BwmRNA-1273-P201DVmRNA-1273-P201-US201-1085US2011085A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-05C@mRNA-1273-P201DVmRNA-1273-P201-US201-1085US2011085A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-10BÞmRNA-1273-P201DVmRNA-1273-P201-US201-1086US2011086AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-09BÞmRNA-1273-P201DVmRNA-1273-P201-US201-1087US2011087AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-08B$mRNA-1273-P201DVmRNA-1273-P201-US201-1087US2011087A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BxmRNA-1273-P201DVmRNA-1273-P201-US201-1087US2011087A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-26B’mRNA-1273-P201DVmRNA-1273-P201-US201-1087US2011087A@P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-16BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1088US2011088AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-14B)mRNA-1273-P201DVmRNA-1273-P201-US201-1088US2011088A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-02B[mRNA-1273-P201DVmRNA-1273-P201-US201-1088US2011088A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-01BxmRNA-1273-P201DVmRNA-1273-P201-US201-1088US2011088A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-28B“mRNA-1273-P201DVmRNA-1273-P201-US201-1088US2011088APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-02BômRNA-1273-P201DVmRNA-1273-P201-US201-1088US2011088A`P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-17BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1089US2011089AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-03B[mRNA-1273-P201DVmRNA-1273-P201-US201-1089US2011089A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-02BxmRNA-1273-P201DVmRNA-1273-P201-US201-1089US2011089A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-30B”mRNA-1273-P201DVmRNA-1273-P201-US201-1089US2011089A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-22CpmRNA-1273-P201DVmRNA-1273-P201-US201-1089US2011089APP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-08BÚmRNA-1273-P201DVmRNA-1273-P201-US201-1090US2011090AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BwmRNA-1273-P201DVmRNA-1273-P201-US201-1090US2011090A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-11BÞmRNA-1273-P201DVmRNA-1273-P201-US201-1091US2011091AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BwmRNA-1273-P201DVmRNA-1273-P201-US201-1091US2011091A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-11BÞmRNA-1273-P201DVmRNA-1273-P201-US201-1092US2011092AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-01BYmRNA-1273-P201DVmRNA-1273-P201-US201-1092US2011092A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-02BxmRNA-1273-P201DVmRNA-1273-P201-US201-1092US2011092A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1093US2011093AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-15BÞmRNA-1273-P201DVmRNA-1273-P201-US201-1093US2011093A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-30BímRNA-1273-P201DVmRNA-1273-P201-US201-1093US2011093A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-27CmRNA-1273-P201DVmRNA-1273-P201-US201-1095US2011095AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-01BwmRNA-1273-P201DVmRNA-1273-P201-US201-1095US2011095A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-12BÞmRNA-1273-P201DVmRNA-1273-P201-US201-1102US2011102AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-02BumRNA-1273-P201DVmRNA-1273-P201-US201-1102US2011102A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-15BÞmRNA-1273-P201DVmRNA-1273-P201-US201-1103US2011103AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-07BmRNA-1273-P201DVmRNA-1273-P201-US201-1103US2011103A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-21BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1103US2011103A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-26C€mRNA-1273-P201DVmRNA-1273-P201-US201-1109US2011109AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BamRNA-1273-P201DVmRNA-1273-P201-US201-1109US2011109A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-23BxmRNA-1273-P201DVmRNA-1273-P201-US201-1109US2011109A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1109US2011109A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-02BúmRNA-1273-P201DVmRNA-1273-P201-US201-1113US2011113AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1114US2011114AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-24B[mRNA-1273-P201DVmRNA-1273-P201-US201-1114US2011114A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1114US2011114A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-04BümRNA-1273-P201DVmRNA-1273-P201-US201-1116US2011116AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25B[mRNA-1273-P201DVmRNA-1273-P201-US201-1116US2011116A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-09BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1117US2011117AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BYmRNA-1273-P201DVmRNA-1273-P201-US201-1117US2011117A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-08BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1118US2011118AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-28B_mRNA-1273-P201DVmRNA-1273-P201-US201-1118US2011118A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-04BümRNA-1273-P201DVmRNA-1273-P201-US201-1118US2011118A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-08BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1120US2011120AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29B_mRNA-1273-P201DVmRNA-1273-P201-US201-1120US2011120A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21BumRNA-1273-P201DVmRNA-1273-P201-US201-1120US2011120A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-02BùmRNA-1273-P201DVmRNA-1273-P201-US201-1120US2011120A@P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-09BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1121US2011121AP05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-07-30BmRNA-1273-P201DVmRNA-1273-P201-US201-1121US2011121A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BZmRNA-1273-P201DVmRNA-1273-P201-US201-1121US2011121A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1122US2011122AP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-21B9mRNA-1273-P201DVmRNA-1273-P201-US201-1122US2011122A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-24B[mRNA-1273-P201DVmRNA-1273-P201-US201-1122US2011122A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1122US2011122A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-05BýmRNA-1273-P201DVmRNA-1273-P201-US201-1122US2011122APP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-21B9mRNA-1273-P201DVmRNA-1273-P201-US201-1123US2011123AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-30BamRNA-1273-P201DVmRNA-1273-P201-US201-1123US2011123A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1123US2011123A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-17BímRNA-1273-P201DVmRNA-1273-P201-US201-1124US2011124AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-31B$mRNA-1273-P201DVmRNA-1273-P201-US201-1124US2011124A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1125US2011125AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BZmRNA-1273-P201DVmRNA-1273-P201-US201-1125US2011125A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-14BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1126US2011126AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-24B[mRNA-1273-P201DVmRNA-1273-P201-US201-1126US2011126A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1126US2011126A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-16BìmRNA-1273-P201DVmRNA-1273-P201-US201-1127US2011127AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-23BZmRNA-1273-P201DVmRNA-1273-P201-US201-1127US2011127A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1127US2011127A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-16BìmRNA-1273-P201DVmRNA-1273-P201-US201-1128US2011128AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-30AmRNA-1273-P201DVmRNA-1273-P201-US201-1128US2011128A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29B\mRNA-1273-P201DVmRNA-1273-P201-US201-1128US2011128A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BÒmRNA-1273-P201DVmRNA-1273-P201-US201-1130US2011130AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-26B]mRNA-1273-P201DVmRNA-1273-P201-US201-1130US2011130A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-08BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1131US2011131AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-24B[mRNA-1273-P201DVmRNA-1273-P201-US201-1131US2011131A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21BvmRNA-1273-P201DVmRNA-1273-P201-US201-1131US2011131A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-05BýmRNA-1273-P201DVmRNA-1273-P201-US201-1131US2011131A@P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-08BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1137US2011137AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-24B[mRNA-1273-P201DVmRNA-1273-P201-US201-1137US2011137A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1137US2011137A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-05BýmRNA-1273-P201DVmRNA-1273-P201-US201-1138US2011138AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29B_mRNA-1273-P201DVmRNA-1273-P201-US201-1138US2011138A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-22BvmRNA-1273-P201DVmRNA-1273-P201-US201-1138US2011138A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-14BÊmRNA-1273-P201DVmRNA-1273-P201-US201-1139US2011139AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-23BZmRNA-1273-P201DVmRNA-1273-P201-US201-1142US2011142AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-06BdmRNA-1273-P201DVmRNA-1273-P201-US201-1142US2011142A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-05BúmRNA-1273-P201DVmRNA-1273-P201-US201-1142US2011142A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-11BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1145US2011145AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1149US2011149AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BÔmRNA-1273-P201DVmRNA-1273-P201-US201-1152US2011152AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29B]mRNA-1273-P201DVmRNA-1273-P201-US201-1152US2011152A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-11BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1153US2011153AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BÓmRNA-1273-P201DVmRNA-1273-P201-US201-1155US2011155AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29B\mRNA-1273-P201DVmRNA-1273-P201-US201-1155US2011155A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-12BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1156US2011156AP05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-07-28BmRNA-1273-P201DVmRNA-1273-P201-US201-1156US2011156A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29B\mRNA-1273-P201DVmRNA-1273-P201-US201-1156US2011156A0P09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) Protocol DeviationConcomitant Medication PART A FOLLOW-UP 2021-03-06BúmRNA-1273-P201DVmRNA-1273-P201-US201-1156US2011156A@P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-12BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1157US2011157AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-28B[mRNA-1273-P201DVmRNA-1273-P201-US201-1157US2011157A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-12BÅmRNA-1273-P201DVmRNA-1273-P201-US201-1159US2011159AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BZmRNA-1273-P201DVmRNA-1273-P201-US201-1159US2011159A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BÑmRNA-1273-P201DVmRNA-1273-P201-US201-1162US2011162AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments SCREENING 2020-07-01ÁPmRNA-1273-P201DVmRNA-1273-P201-US201-1162US2011162A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-18BÅmRNA-1273-P201DVmRNA-1273-P201-US202-1003US2021003AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1003US2021003A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-15BnmRNA-1273-P201DVmRNA-1273-P201-US202-1003US2021003A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-13BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1003US2021003A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1003US2021003APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-18BëmRNA-1273-P201DVmRNA-1273-P201-US202-1003US2021003A`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-03-15C0mRNA-1273-P201DVmRNA-1273-P201-US202-1003US2021003ApSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1004US2021004AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1004US2021004A P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-15CpmRNA-1273-P201DVmRNA-1273-P201-US202-1004US2021004A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1007US2021007AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1007US2021007A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1011US2021011AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1011US2021011A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1012US2021012AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1012US2021012A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1015US2021015AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1015US2021015A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-24BXmRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-15BŒmRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-13B©mRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018APP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-18BëmRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018A`P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-13B.mRNA-1273-P201DVmRNA-1273-P201-US202-1018US2021018ApSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1019US2021019AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1019US2021019A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-15BnmRNA-1273-P201DVmRNA-1273-P201-US202-1019US2021019A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-13BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1019US2021019A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1019US2021019APP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-19BìmRNA-1273-P201DVmRNA-1273-P201-US202-1019US2021019A`SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1020US2021020AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1020US2021020A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-16BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1020US2021020A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1021US2021021AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1021US2021021A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US202-1022US2021022AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1022US2021022A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-07BcmRNA-1273-P201DVmRNA-1273-P201-US202-1022US2021022A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BqmRNA-1273-P201DVmRNA-1273-P201-US202-1022US2021022A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-16BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1022US2021022APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-13B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1022US2021022A`P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-20BêmRNA-1273-P201DVmRNA-1273-P201-US202-1022US2021022ApSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1031US2021031AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1031US2021031A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THEICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US202-1043US2021043AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-16BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1043US2021043A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10B£mRNA-1273-P201DVmRNA-1273-P201-US202-1058US2021058AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-20BMmRNA-1273-P201DVmRNA-1273-P201-US202-1058US2021058A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-09BamRNA-1273-P201DVmRNA-1273-P201-US202-1058US2021058A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BnmRNA-1273-P201DVmRNA-1273-P201-US202-1058US2021058A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1059US2021059AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-21BêmRNA-1273-P201DVmRNA-1273-P201-US202-1059US2021059A P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-18C`mRNA-1273-P201DVmRNA-1273-P201-US202-1063US2021063AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BnmRNA-1273-P201DVmRNA-1273-P201-US202-1063US2021063A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20B‹mRNA-1273-P201DVmRNA-1273-P201-US202-1063US2021063A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B§mRNA-1273-P201DVmRNA-1273-P201-US202-1063US2021063A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BîmRNA-1273-P201DVmRNA-1273-P201-US202-1064US2021064AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25BnmRNA-1273-P201DVmRNA-1273-P201-US202-1064US2021064A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-23BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1064US2021064A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-24BªmRNA-1273-P201DVmRNA-1273-P201-US202-1064US2021064A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BêmRNA-1273-P201DVmRNA-1273-P201-US202-1064US2021064APP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-24C`mRNA-1273-P201DVmRNA-1273-P201-US202-1067US2021067AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BnmRNA-1273-P201DVmRNA-1273-P201-US202-1067US2021067A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1067US2021067A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1067US2021067A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BëmRNA-1273-P201DVmRNA-1273-P201-US202-1068US2021068AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-21BêmRNA-1273-P201DVmRNA-1273-P201-US202-1068US2021068A P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-18C`mRNA-1273-P201DVmRNA-1273-P201-US202-1074US2021074AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BpmRNA-1273-P201DVmRNA-1273-P201-US202-1074US2021074A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-18B‹mRNA-1273-P201DVmRNA-1273-P201-US202-1074US2021074A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-16B¨mRNA-1273-P201DVmRNA-1273-P201-US202-1074US2021074A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-18C`mRNA-1273-P201DVmRNA-1273-P201-US202-1080US2021080AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-09BamRNA-1273-P201DVmRNA-1273-P201-US202-1080US2021080A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BnmRNA-1273-P201DVmRNA-1273-P201-US202-1080US2021080A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-22BŒmRNA-1273-P201DVmRNA-1273-P201-US202-1080US2021080A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1080US2021080APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BímRNA-1273-P201DVmRNA-1273-P201-US202-1082US2021082AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BomRNA-1273-P201DVmRNA-1273-P201-US202-1082US2021082A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19B‹mRNA-1273-P201DVmRNA-1273-P201-US202-1082US2021082A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-16B§mRNA-1273-P201DVmRNA-1273-P201-US202-1084US2021084AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BnmRNA-1273-P201DVmRNA-1273-P201-US202-1084US2021084A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-22BŒmRNA-1273-P201DVmRNA-1273-P201-US202-1084US2021084A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1089US2021089AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25BnmRNA-1273-P201DVmRNA-1273-P201-US202-1089US2021089A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-23BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1089US2021089A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BêmRNA-1273-P201DVmRNA-1273-P201-US202-1090US2021090AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BpmRNA-1273-P201DVmRNA-1273-P201-US202-1090US2021090A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-18BªmRNA-1273-P201DVmRNA-1273-P201-US202-1093US2021093AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-11BemRNA-1273-P201DVmRNA-1273-P201-US202-1093US2021093A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BomRNA-1273-P201DVmRNA-1273-P201-US202-1093US2021093A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19B‹mRNA-1273-P201DVmRNA-1273-P201-US202-1093US2021093A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-18B©mRNA-1273-P201DVmRNA-1273-P201-US202-1093US2021093APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-24BìmRNA-1273-P201DVmRNA-1273-P201-US202-1093US2021093A`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-22CmRNA-1273-P201DVmRNA-1273-P201-US202-1094US2021094AP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-06B mRNA-1273-P201DVmRNA-1273-P201-US202-1094US2021094A P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-07-15B)mRNA-1273-P201DVmRNA-1273-P201-US202-1094US2021094A0P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-07-17B+mRNA-1273-P201DVmRNA-1273-P201-US202-1094US2021094A@P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-06B?mRNA-1273-P201DVmRNA-1273-P201-US202-1096US2021096AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-15B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1101US2021101AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-14BcmRNA-1273-P201DVmRNA-1273-P201-US202-1101US2021101A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-18BgmRNA-1273-P201DVmRNA-1273-P201-US202-1101US2021101A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-23BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1101US2021101A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-20B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1101US2021101APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BêmRNA-1273-P201DVmRNA-1273-P201-US202-1101US2021101A`P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-25CpmRNA-1273-P201DVmRNA-1273-P201-US202-1107US2021107AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BïmRNA-1273-P201DVmRNA-1273-P201-US202-1114US2021114AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-15BRmRNA-1273-P201DVmRNA-1273-P201-US202-1114US2021114A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20BumRNA-1273-P201DVmRNA-1273-P201-US202-1114US2021114A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-09B§mRNA-1273-P201DVmRNA-1273-P201-US202-1114US2021114A@P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-16BmRNA-1273-P201DVmRNA-1273-P201-US202-1115US2021115AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BXmRNA-1273-P201DVmRNA-1273-P201-US202-1115US2021115A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14BomRNA-1273-P201DVmRNA-1273-P201-US202-1115US2021115A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1115US2021115A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-08B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1121US2021121AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-11BÀmRNA-1273-P201DVmRNA-1273-P201-US202-1130US2021130AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25B\mRNA-1273-P201DVmRNA-1273-P201-US202-1130US2021130A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1130US2021130A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-08B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1133US2021133AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-14BQmRNA-1273-P201DVmRNA-1273-P201-US202-1133US2021133A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14BomRNA-1273-P201DVmRNA-1273-P201-US202-1133US2021133A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-12BŒmRNA-1273-P201DVmRNA-1273-P201-US202-1133US2021133A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-10B¨mRNA-1273-P201DVmRNA-1273-P201-US202-1135US2021135AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-06A mRNA-1273-P201DVmRNA-1273-P201-US202-1135US2021135A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21B‹mRNA-1273-P201DVmRNA-1273-P201-US202-1135US2021135A0P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-26BìmRNA-1273-P201DVmRNA-1273-P201-US202-1135US2021135A@P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-22CpmRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25BnmRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-23B©mRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BêmRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137A@P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-15B&mRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137APP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-21B,mRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137A`P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-24C`mRNA-1273-P201DVmRNA-1273-P201-US202-1137US2021137ApP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-18BHmRNA-1273-P201DVmRNA-1273-P201-US202-1138US2021138AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BnmRNA-1273-P201DVmRNA-1273-P201-US202-1138US2021138A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-09B€mRNA-1273-P201DVmRNA-1273-P201-US202-1138US2021138A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B§mRNA-1273-P201DVmRNA-1273-P201-US202-1144US2021144AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BnmRNA-1273-P201DVmRNA-1273-P201-US202-1144US2021144A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21B‹mRNA-1273-P201DVmRNA-1273-P201-US202-1144US2021144A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1144US2021144A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BëmRNA-1273-P201DVmRNA-1273-P201-US202-1144US2021144APP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-10BCmRNA-1273-P201DVmRNA-1273-P201-US202-1145US2021145AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-15BhmRNA-1273-P201DVmRNA-1273-P201-US202-1145US2021145A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BnmRNA-1273-P201DVmRNA-1273-P201-US202-1145US2021145A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20B‹mRNA-1273-P201DVmRNA-1273-P201-US202-1145US2021145A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-16B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1145US2021145APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BìmRNA-1273-P201DVmRNA-1273-P201-US202-1145US2021145A`P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-24C mRNA-1273-P201DVmRNA-1273-P201-US202-1147US2021147AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BnmRNA-1273-P201DVmRNA-1273-P201-US202-1147US2021147A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1147US2021147A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1147US2021147A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BëmRNA-1273-P201DVmRNA-1273-P201-US202-1151US2021151AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25BnmRNA-1273-P201DVmRNA-1273-P201-US202-1151US2021151A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-23BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1151US2021151A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-24BªmRNA-1273-P201DVmRNA-1273-P201-US202-1151US2021151A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-29BìmRNA-1273-P201DVmRNA-1273-P201-US202-1154US2021154AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BnmRNA-1273-P201DVmRNA-1273-P201-US202-1154US2021154A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-22BŒmRNA-1273-P201DVmRNA-1273-P201-US202-1154US2021154A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1154US2021154A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BëmRNA-1273-P201DVmRNA-1273-P201-US202-1155US2021155AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-13BbmRNA-1273-P201DVmRNA-1273-P201-US202-1155US2021155A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-27BpmRNA-1273-P201DVmRNA-1273-P201-US202-1155US2021155A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-22B‰mRNA-1273-P201DVmRNA-1273-P201-US202-1155US2021155A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-18BÂmRNA-1273-P201DVmRNA-1273-P201-US202-1161US2021161AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25BnmRNA-1273-P201DVmRNA-1273-P201-US202-1162US2021162AP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-06-16AmRNA-1273-P201DVmRNA-1273-P201-US202-1162US2021162A P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-06-23BmRNA-1273-P201DVmRNA-1273-P201-US202-1162US2021162A0P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-07-13B$mRNA-1273-P201DVmRNA-1273-P201-US202-1164US2021164AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-23BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1164US2021164A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-23B©mRNA-1273-P201DVmRNA-1273-P201-US202-1164US2021164A0P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-07B=mRNA-1273-P201DVmRNA-1273-P201-US202-1166US2021166AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BnmRNA-1273-P201DVmRNA-1273-P201-US202-1166US2021166A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1166US2021166A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1166US2021166A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BëmRNA-1273-P201DVmRNA-1273-P201-US202-1166US2021166APP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-22CpmRNA-1273-P201DVmRNA-1273-P201-US202-1167US2021167AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25BnmRNA-1273-P201DVmRNA-1273-P201-US202-1167US2021167A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-30B°mRNA-1273-P201DVmRNA-1273-P201-US202-1167US2021167A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BêmRNA-1273-P201DVmRNA-1273-P201-US202-1175US2021175AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25BnmRNA-1273-P201DVmRNA-1273-P201-US202-1175US2021175A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-20B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1175US2021175A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BêmRNA-1273-P201DVmRNA-1273-P201-US202-1179US2021179AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-14BcmRNA-1273-P201DVmRNA-1273-P201-US202-1179US2021179A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BrmRNA-1273-P201DVmRNA-1273-P201-US202-1179US2021179A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-23BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1179US2021179A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-20B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1179US2021179APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BêmRNA-1273-P201DVmRNA-1273-P201-US202-1180US2021180AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-29BrmRNA-1273-P201DVmRNA-1273-P201-US202-1180US2021180A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-27BŽmRNA-1273-P201DVmRNA-1273-P201-US202-1180US2021180A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-20B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1180US2021180A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-27BêmRNA-1273-P201DVmRNA-1273-P201-US202-1182US2021182AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-24C`mRNA-1273-P201DVmRNA-1273-P201-US202-1182US2021182A P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÂmRNA-1273-P201DVmRNA-1273-P201-US202-1185US2021185AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-16BqmRNA-1273-P201DVmRNA-1273-P201-US202-1185US2021185A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-12BŒmRNA-1273-P201DVmRNA-1273-P201-US202-1185US2021185A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-08B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1186US2021186AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-17BTmRNA-1273-P201DVmRNA-1273-P201-US202-1186US2021186A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-15BpmRNA-1273-P201DVmRNA-1273-P201-US202-1186US2021186A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-12BŒmRNA-1273-P201DVmRNA-1273-P201-US202-1186US2021186A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-08B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1186US2021186APP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-07B+mRNA-1273-P201DVmRNA-1273-P201-US202-1189US2021189AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-17BTmRNA-1273-P201DVmRNA-1273-P201-US202-1189US2021189A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-15BpmRNA-1273-P201DVmRNA-1273-P201-US202-1189US2021189A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-08B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1190US2021190AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-07BJmRNA-1273-P201DVmRNA-1273-P201-US202-1190US2021190A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BXmRNA-1273-P201DVmRNA-1273-P201-US202-1190US2021190A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20BumRNA-1273-P201DVmRNA-1273-P201-US202-1190US2021190A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-08B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1190US2021190APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-17BímRNA-1273-P201DVmRNA-1273-P201-US202-1192US2021192AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10BŠmRNA-1273-P201DVmRNA-1273-P201-US202-1192US2021192A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-08B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1196US2021196AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BRmRNA-1273-P201DVmRNA-1273-P201-US202-1196US2021196A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BSmRNA-1273-P201DVmRNA-1273-P201-US202-1196US2021196A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B‹mRNA-1273-P201DVmRNA-1273-P201-US202-1196US2021196A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-14B¦mRNA-1273-P201DVmRNA-1273-P201-US202-1198US2021198AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BUmRNA-1273-P201DVmRNA-1273-P201-US202-1198US2021198A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BVmRNA-1273-P201DVmRNA-1273-P201-US202-1198US2021198A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17BŽmRNA-1273-P201DVmRNA-1273-P201-US202-1198US2021198A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-14B©mRNA-1273-P201DVmRNA-1273-P201-US202-1198US2021198APP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-04B%mRNA-1273-P201DVmRNA-1273-P201-US202-1205US2021205AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BXmRNA-1273-P201DVmRNA-1273-P201-US202-1205US2021205A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BYmRNA-1273-P201DVmRNA-1273-P201-US202-1205US2021205A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B‘mRNA-1273-P201DVmRNA-1273-P201-US202-1205US2021205A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-14B¬mRNA-1273-P201DVmRNA-1273-P201-US202-1205US2021205APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-16BìmRNA-1273-P201DVmRNA-1273-P201-US202-1206US2021206AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BRmRNA-1273-P201DVmRNA-1273-P201-US202-1206US2021206A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19BnmRNA-1273-P201DVmRNA-1273-P201-US202-1207US2021207AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-06B*mRNA-1273-P201DVmRNA-1273-P201-US202-1208US2021208AP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-19B2mRNA-1273-P201DVmRNA-1273-P201-US202-1208US2021208A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-05B$mRNA-1273-P201DVmRNA-1273-P201-US202-1230US2021230AP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) Protocol DeviationConcomitant Medication PART A FOLLOW-UP 2021-02-17BãmRNA-1273-P201DVmRNA-1273-P201-US203-1002US2031002AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14B‹mRNA-1273-P201DVmRNA-1273-P201-US203-1002US2031002A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-18BëmRNA-1273-P201DVmRNA-1273-P201-US203-1004US2031004AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-15BŒmRNA-1273-P201DVmRNA-1273-P201-US203-1004US2031004A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-18BëmRNA-1273-P201DVmRNA-1273-P201-US203-1011US2031011AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-13BŠmRNA-1273-P201DVmRNA-1273-P201-US203-1011US2031011A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-18BëmRNA-1273-P201DVmRNA-1273-P201-US203-1014US2031014AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14B‹mRNA-1273-P201DVmRNA-1273-P201-US203-1014US2031014A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10B¦mRNA-1273-P201DVmRNA-1273-P201-US203-1014US2031014A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-18BëmRNA-1273-P201DVmRNA-1273-P201-US203-1016US2031016AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1020US2031020AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14B‹mRNA-1273-P201DVmRNA-1273-P201-US203-1020US2031020A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10B¦mRNA-1273-P201DVmRNA-1273-P201-US203-1020US2031020A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-18BëmRNA-1273-P201DVmRNA-1273-P201-US203-1022US2031022AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14B‹mRNA-1273-P201DVmRNA-1273-P201-US203-1023US2031023AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14B‹mRNA-1273-P201DVmRNA-1273-P201-US203-1023US2031023A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-18BëmRNA-1273-P201DVmRNA-1273-P201-US203-1029US2031029AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BpmRNA-1273-P201DVmRNA-1273-P201-US203-1029US2031029A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19BŒmRNA-1273-P201DVmRNA-1273-P201-US203-1029US2031029A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-16B¨mRNA-1273-P201DVmRNA-1273-P201-US203-1029US2031029A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-21BêmRNA-1273-P201DVmRNA-1273-P201-US203-1030US2031030AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-29BXmRNA-1273-P201DVmRNA-1273-P201-US203-1038US2031038AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-22BêmRNA-1273-P201DVmRNA-1273-P201-US203-1038US2031038A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-19C`mRNA-1273-P201DVmRNA-1273-P201-US203-1040US2031040AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-18BnmRNA-1273-P201DVmRNA-1273-P201-US203-1040US2031040A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-13B¦mRNA-1273-P201DVmRNA-1273-P201-US203-1040US2031040A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BêmRNA-1273-P201DVmRNA-1273-P201-US203-1040US2031040A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-17C`mRNA-1273-P201DVmRNA-1273-P201-US203-1042US2031042AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1043US2031043AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1056US2031056AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-18BnmRNA-1273-P201DVmRNA-1273-P201-US203-1056US2031056A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-16BŠmRNA-1273-P201DVmRNA-1273-P201-US203-1056US2031056A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-13B¦mRNA-1273-P201DVmRNA-1273-P201-US203-1060US2031060AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1062US2031062AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1071US2031071AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1072US2031072AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-23BRmRNA-1273-P201DVmRNA-1273-P201-US203-1072US2031072A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BomRNA-1273-P201DVmRNA-1273-P201-US203-1072US2031072A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19B‹mRNA-1273-P201DVmRNA-1273-P201-US203-1072US2031072A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-16B§mRNA-1273-P201DVmRNA-1273-P201-US203-1072US2031072APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-22BêmRNA-1273-P201DVmRNA-1273-P201-US203-1079US2031079AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1080US2031080AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US203-1081US2031081AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-03B=mRNA-1273-P201DVmRNA-1273-P201-US203-1082US2031082AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments SCREENING 2020-06-04.mRNA-1273-P201DVmRNA-1273-P201-US203-1086US2031086AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14BomRNA-1273-P201DVmRNA-1273-P201-US203-1086US2031086A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10BŠmRNA-1273-P201DVmRNA-1273-P201-US203-1100US2031100AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BSmRNA-1273-P201DVmRNA-1273-P201-US203-1100US2031100A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19BomRNA-1273-P201DVmRNA-1273-P201-US203-1101US2031101AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-20BmRNA-1273-P201DVmRNA-1273-P201-US203-1106US2031106AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-15BRmRNA-1273-P201DVmRNA-1273-P201-US203-1106US2031106A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14BomRNA-1273-P201DVmRNA-1273-P201-US203-1106US2031106A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-10BŠmRNA-1273-P201DVmRNA-1273-P201-US203-1106US2031106A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-08B¦mRNA-1273-P201DVmRNA-1273-P201-US203-1108US2031108AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-08-20B.mRNA-1273-P201DVmRNA-1273-P201-US203-1112US2031112AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-02BEmRNA-1273-P201DVmRNA-1273-P201-US203-1116US2031116AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-08-27B<mRNA-1273-P201DVmRNA-1273-P201-US203-1131US2031131AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19BnmRNA-1273-P201DVmRNA-1273-P201-US204-1003US2041003AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-04-01CmRNA-1273-P201DVmRNA-1273-P201-US204-1003US2041003A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÅmRNA-1273-P201DVmRNA-1273-P201-US204-1005US2041005AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-19C°mRNA-1273-P201DVmRNA-1273-P201-US204-1006US2041006AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-19BnmRNA-1273-P201DVmRNA-1273-P201-US204-1007US2041007AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÆmRNA-1273-P201DVmRNA-1273-P201-US204-1008US2041008AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BêmRNA-1273-P201DVmRNA-1273-P201-US204-1008US2041008A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-11BHmRNA-1273-P201DVmRNA-1273-P201-US204-1010US2041010AP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) Protocol DeviationConcomitant Medication PART A FOLLOW-UP 2021-02-19C°mRNA-1273-P201DVmRNA-1273-P201-US204-1010US2041010A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-12BÆmRNA-1273-P201DVmRNA-1273-P201-US204-1011US2041011AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-20BêmRNA-1273-P201DVmRNA-1273-P201-US204-1011US2041011A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-02-17C`mRNA-1273-P201DVmRNA-1273-P201-US204-1011US2041011A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-16BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1011US2041011A@P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-15AðmRNA-1273-P201DVmRNA-1273-P201-US204-1011US2041011APP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-17BNmRNA-1273-P201DVmRNA-1273-P201-US204-1012US2041012AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-22BmRNA-1273-P201DVmRNA-1273-P201-US204-1012US2041012A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-16B¨mRNA-1273-P201DVmRNA-1273-P201-US204-1013US2041013AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-13BŠmRNA-1273-P201DVmRNA-1273-P201-US204-1013US2041013A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-10BÄmRNA-1273-P201DVmRNA-1273-P201-US204-1014US2041014AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-13BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1014US2041014A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-08B)mRNA-1273-P201DVmRNA-1273-P201-US204-1016US2041016AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20BmRNA-1273-P201DVmRNA-1273-P201-US204-1016US2041016A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-16B¨mRNA-1273-P201DVmRNA-1273-P201-US204-1016US2041016A0P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-06B#mRNA-1273-P201DVmRNA-1273-P201-US204-1019US2041019AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments PART A FOLLOW-UP 2020-08-31B[mRNA-1273-P201DVmRNA-1273-P201-US204-1019US2041019A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-16BÆmRNA-1273-P201DVmRNA-1273-P201-US204-1019US2041019A0P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-28B9mRNA-1273-P201DVmRNA-1273-P201-US204-1022US2041022AP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) Protocol DeviationConcomitant Medication PART A FOLLOW-UP 2021-02-12BýmRNA-1273-P201DVmRNA-1273-P201-US204-1023US2041023AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-15BÆmRNA-1273-P201DVmRNA-1273-P201-US204-1026US2041026AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-12BHmRNA-1273-P201DVmRNA-1273-P201-US204-1026US2041026A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-17BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1027US2041027AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÉmRNA-1273-P201DVmRNA-1273-P201-US204-1029US2041029AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÉmRNA-1273-P201DVmRNA-1273-P201-US204-1030US2041030AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18BÉmRNA-1273-P201DVmRNA-1273-P201-US204-1034US2041034AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-17BÈmRNA-1273-P201DVmRNA-1273-P201-US204-1046US2041046AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-19BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1046US2041046A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-01BZmRNA-1273-P201DVmRNA-1273-P201-US204-1047US2041047AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-16BÆmRNA-1273-P201DVmRNA-1273-P201-US204-1048US2041048AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-17B©mRNA-1273-P201DVmRNA-1273-P201-US204-1048US2041048A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-17BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1049US2041049AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANICH/GCP Deviation Other GCP Deviation PART A FOLLOW-UP 2021-02-17C0mRNA-1273-P201DVmRNA-1273-P201-US204-1049US2041049A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-08B#mRNA-1273-P201DVmRNA-1273-P201-US204-1049US2041049A0P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-11BdmRNA-1273-P201DVmRNA-1273-P201-US204-1051US2041051AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-17BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1055US2041055AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-25BmRNA-1273-P201DVmRNA-1273-P201-US204-1055US2041055A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-07B#mRNA-1273-P201DVmRNA-1273-P201-US204-1056US2041056AP07: SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION (POST VACCINATION) Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-30BmRNA-1273-P201DVmRNA-1273-P201-US204-1058US2041058AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-07B#mRNA-1273-P201DVmRNA-1273-P201-US204-1059US2041059AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-06B#mRNA-1273-P201DVmRNA-1273-P201-US204-1060US2041060AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-09-02B]mRNA-1273-P201DVmRNA-1273-P201-US204-1060US2041060A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-04-13CÀmRNA-1273-P201DVmRNA-1273-P201-US204-1060US2041060A0P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-02B]mRNA-1273-P201DVmRNA-1273-P201-US204-1061US2041061AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-02B]mRNA-1273-P201DVmRNA-1273-P201-US204-1064US2041064AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-13B$mRNA-1273-P201DVmRNA-1273-P201-US204-1064US2041064A P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-09-24BmmRNA-1273-P201DVmRNA-1273-P201-US204-1071US2041071AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-22BmRNA-1273-P201DVmRNA-1273-P201-US204-1071US2041071A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-18BªmRNA-1273-P201DVmRNA-1273-P201-US204-1075US2041075AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-13B*mRNA-1273-P201DVmRNA-1273-P201-US204-1075US2041075A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-21B2mRNA-1273-P201DVmRNA-1273-P201-US204-1076US2041076AP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-02-05BùmRNA-1273-P201DVmRNA-1273-P201-US204-1077US2041077AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-01BmRNA-1273-P201DVmRNA-1273-P201-US204-1078US2041078AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-01BmRNA-1273-P201DVmRNA-1273-P201-US204-1088US2041088AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-29BìmRNA-1273-P201DVmRNA-1273-P201-US204-1089US2041089AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-25BnmRNA-1273-P201DVmRNA-1273-P201-US204-1090US2041090AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-14B%mRNA-1273-P201DVmRNA-1273-P201-US204-1090US2041090A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-12BBmRNA-1273-P201DVmRNA-1273-P201-US204-1090US2041090A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-17BÁmRNA-1273-P201DVmRNA-1273-P201-US204-1091US2041091AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-12B@mRNA-1273-P201DVmRNA-1273-P201-US204-1091US2041091A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-31BìmRNA-1273-P201DVmRNA-1273-P201-US204-1092US2041092AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-28BRmRNA-1273-P201DVmRNA-1273-P201-US204-1092US2041092A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-28BqmRNA-1273-P201DVmRNA-1273-P201-US204-1092US2041092A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-24BªmRNA-1273-P201DVmRNA-1273-P201-US204-1092US2041092A@P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-13B$mRNA-1273-P201DVmRNA-1273-P201-US204-1094US2041094AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B/mRNA-1273-P201DVmRNA-1273-P201-US204-1096US2041096AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-15BŒmRNA-1273-P201DVmRNA-1273-P201-US204-1102US2041102AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-11B©mRNA-1273-P201DVmRNA-1273-P201-US204-1103US2041103AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-10B¨mRNA-1273-P201DVmRNA-1273-P201-US204-1104US2041104AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-18B°mRNA-1273-P201DVmRNA-1273-P201-US204-1104US2041104A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-19BÐmRNA-1273-P201DVmRNA-1273-P201-US204-1107US2041107AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-10B¨mRNA-1273-P201DVmRNA-1273-P201-US204-1107US2041107A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-09AàmRNA-1273-P201DVmRNA-1273-P201-US204-1108US2041108AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14BomRNA-1273-P201DVmRNA-1273-P201-US204-1108US2041108A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-12BŒmRNA-1273-P201DVmRNA-1273-P201-US204-1109US2041109AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-12BŒmRNA-1273-P201DVmRNA-1273-P201-US204-1109US2041109A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-12BªmRNA-1273-P201DVmRNA-1273-P201-US204-1112US2041112AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-11B©mRNA-1273-P201DVmRNA-1273-P201-US204-1112US2041112A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-18B6mRNA-1273-P201DVmRNA-1273-P201-US204-1113US2041113AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-07A€mRNA-1273-P201DVmRNA-1273-P201-US204-1113US2041113A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-28BmRNA-1273-P201DVmRNA-1273-P201-US204-1113US2041113A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-08BemRNA-1273-P201DVmRNA-1273-P201-US204-1114US2041114AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-10B¨mRNA-1273-P201DVmRNA-1273-P201-US204-1114US2041114A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-03B'mRNA-1273-P201DVmRNA-1273-P201-US204-1115US2041115AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BTmRNA-1273-P201DVmRNA-1273-P201-US204-1115US2041115A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20BpmRNA-1273-P201DVmRNA-1273-P201-US204-1115US2041115A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17BŒmRNA-1273-P201DVmRNA-1273-P201-US204-1117US2041117AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-11B©mRNA-1273-P201DVmRNA-1273-P201-US204-1118US2041118AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-15BÉmRNA-1273-P201DVmRNA-1273-P201-US204-1119US2041119AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-11B¾mRNA-1273-P201DVmRNA-1273-P201-US204-1121US2041121AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-10-21BqmRNA-1273-P201DVmRNA-1273-P201-US204-1121US2041121A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-18BmRNA-1273-P201DVmRNA-1273-P201-US204-1121US2041121A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-15BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1123US2041123AP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-10B¨mRNA-1273-P201DVmRNA-1273-P201-US204-1125US2041125AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-10-20BrmRNA-1273-P201DVmRNA-1273-P201-US204-1125US2041125A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-15BÉmRNA-1273-P201DVmRNA-1273-P201-US204-1126US2041126AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-17BTmRNA-1273-P201DVmRNA-1273-P201-US204-1126US2041126A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-15BpmRNA-1273-P201DVmRNA-1273-P201-US204-1126US2041126A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-12BŒmRNA-1273-P201DVmRNA-1273-P201-US204-1126US2041126A@P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-12BªmRNA-1273-P201DVmRNA-1273-P201-US204-1127US2041127AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-10B¨mRNA-1273-P201DVmRNA-1273-P201-US204-1131US2041131AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-13BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1131US2041131A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-10B+mRNA-1273-P201DVmRNA-1273-P201-US204-1132US2041132AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-08-13B1mRNA-1273-P201DVmRNA-1273-P201-US204-1132US2041132A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-11B©mRNA-1273-P201DVmRNA-1273-P201-US204-1132US2041132A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-10BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1136US2041136AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-15B¨mRNA-1273-P201DVmRNA-1273-P201-US204-1136US2041136A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-21BmRNA-1273-P201DVmRNA-1273-P201-US204-1139US2041139AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-13BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1142US2041142AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-19BmRNA-1273-P201DVmRNA-1273-P201-US204-1144US2041144AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-11B©mRNA-1273-P201DVmRNA-1273-P201-US204-1145US2041145AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-19BmRNA-1273-P201DVmRNA-1273-P201-US204-1145US2041145A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-17B©mRNA-1273-P201DVmRNA-1273-P201-US204-1146US2041146AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-19BmRNA-1273-P201DVmRNA-1273-P201-US204-1146US2041146A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-16BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1149US2041149AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-23BmRNA-1273-P201DVmRNA-1273-P201-US204-1150US2041150AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-24BtmRNA-1273-P201DVmRNA-1273-P201-US204-1150US2041150A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-17BªmRNA-1273-P201DVmRNA-1273-P201-US204-1150US2041150A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-20BmRNA-1273-P201DVmRNA-1273-P201-US204-1151US2041151AP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-23BmRNA-1273-P201DVmRNA-1273-P201-US204-1155US2041155AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-08B_mRNA-1273-P201DVmRNA-1273-P201-US204-1155US2041155A P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-12-02B–mRNA-1273-P201DVmRNA-1273-P201-US204-1155US2041155A0P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-20BÇmRNA-1273-P201DVmRNA-1273-P201-US204-1166US2041166AP08: PROCEDURE COMPLETED BUT NOT REQUIRED PER PROTOCOL (ANY PROCEDURE) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-23BmRNA-1273-P201DVmRNA-1273-P201-US205-1001US2051001AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-26ÁmRNA-1273-P201DVmRNA-1273-P201-US205-1001US2051001A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-22BémRNA-1273-P201DVmRNA-1273-P201-US205-1001US2051001A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-22BémRNA-1273-P201DVmRNA-1273-P201-US205-1002US2051002AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-26ÁpmRNA-1273-P201DVmRNA-1273-P201-US205-1003US2051003AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-26Á0mRNA-1273-P201DVmRNA-1273-P201-US205-1003US2051003A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-11AàmRNA-1273-P201DVmRNA-1273-P201-US205-1003US2051003A0VACCINATION IS NOT ACCORDING TO THE PROTOCOL - DAY 1 VISIT DOSING PROCEDURE WAS NOT PERFORMED ACCORDING TO THE PHARMACY MANUAL AND DOSING WORKSHEET INSTRUCTION. Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US205-1004US2051004AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-26.mRNA-1273-P201DVmRNA-1273-P201-US205-1004US2051004A I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-06-11.mRNA-1273-P201DVmRNA-1273-P201-US205-1005US2051005AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-26.mRNA-1273-P201DVmRNA-1273-P201-US205-1005US2051005A I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-06-11.mRNA-1273-P201DVmRNA-1273-P201-US205-1006US2051006AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-26.mRNA-1273-P201DVmRNA-1273-P201-US205-1006US2051006A I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-06-11.mRNA-1273-P201DVmRNA-1273-P201-US205-1007US2051007AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-26.mRNA-1273-P201DVmRNA-1273-P201-US205-1007US2051007A I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-06-11.mRNA-1273-P201DVmRNA-1273-P201-US205-1008US2051008AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-26Á0mRNA-1273-P201DVmRNA-1273-P201-US205-1008US2051008A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-11AàmRNA-1273-P201DVmRNA-1273-P201-US205-1009US2051009AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing SCREENING 2020-05-27Á`mRNA-1273-P201DVmRNA-1273-P201-US205-1011US2051011AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-17B-mRNA-1273-P201DVmRNA-1273-P201-US205-1011US2051011A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-29B9mRNA-1273-P201DVmRNA-1273-P201-US205-1012US2051012AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US205-1017US2051017AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-04B™mRNA-1273-P201DVmRNA-1273-P201-US205-1020US2051020AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-22BémRNA-1273-P201DVmRNA-1273-P201-US205-1022US2051022AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-03AmRNA-1273-P201DVmRNA-1273-P201-US205-1022US2051022A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-04B›mRNA-1273-P201DVmRNA-1273-P201-US205-1024US2051024AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-04BœmRNA-1273-P201DVmRNA-1273-P201-US205-1025US2051025AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-04B™mRNA-1273-P201DVmRNA-1273-P201-US205-1026US2051026AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US205-1026US2051026A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-25BmRNA-1273-P201DVmRNA-1273-P201-US205-1027US2051027AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-04B–mRNA-1273-P201DVmRNA-1273-P201-US205-1028US2051028AP05.04: SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (2ND VACCINATION NOT GIVEN ) Protocol DeviationStudy Treatment Admin/DispensePART A FOLLOW-UP 2020-09-08BamRNA-1273-P201DVmRNA-1273-P201-US205-1029US2051029AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-04BšmRNA-1273-P201DVmRNA-1273-P201-US205-1030US2051030AP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT PROCESSED AS OUTLINED IN LAB MANUAL) Protocol DeviationMissing Endpoint Assessments PART A FOLLOW-UP 2020-09-24BrmRNA-1273-P201DVmRNA-1273-P201-US205-1032US2051032AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US205-1032US2051032A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-25BmRNA-1273-P201DVmRNA-1273-P201-US205-1032US2051032A0P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-07-27B8mRNA-1273-P201DVmRNA-1273-P201-US205-1033US2051033AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-17B,mRNA-1273-P201DVmRNA-1273-P201-US205-1033US2051033A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-07-28B7mRNA-1273-P201DVmRNA-1273-P201-US205-1035US2051035AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BímRNA-1273-P201DVmRNA-1273-P201-US205-1035US2051035A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-17B,mRNA-1273-P201DVmRNA-1273-P201-US205-1035US2051035A0P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-07-30B9mRNA-1273-P201DVmRNA-1273-P201-US205-1042US2051042AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US205-1042US2051042A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-21BêmRNA-1273-P201DVmRNA-1273-P201-US205-1043US2051043AP07: SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION (POST VACCINATION) Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US205-1044US2051044AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-17B+mRNA-1273-P201DVmRNA-1273-P201-US205-1044US2051044A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-07-28B6mRNA-1273-P201DVmRNA-1273-P201-US205-1059US2051059AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-18B6mRNA-1273-P201DVmRNA-1273-P201-US205-1071US2051071AP09: ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION Protocol DeviationConcomitant Medication PART A FOLLOW-UP 2020-08-25B:mRNA-1273-P201DVmRNA-1273-P201-US205-1072US2051072AP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-09-09BBmRNA-1273-P201DVmRNA-1273-P201-US205-1084US2051084AP09: ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION Protocol DeviationConcomitant Medication BLINDED TREATMENT 2020-08-11B*mRNA-1273-P201DVmRNA-1273-P201-US205-1111US2051111AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-04BzmRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BSmRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BomRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21BŒmRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B§mRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BímRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001A`P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BMmRNA-1273-P201DVmRNA-1273-P201-US206-1001US2061001ApP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-10B%mRNA-1273-P201DVmRNA-1273-P201-US206-1003US2061003AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BSmRNA-1273-P201DVmRNA-1273-P201-US206-1003US2061003A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-22BomRNA-1273-P201DVmRNA-1273-P201-US206-1003US2061003A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1003US2061003A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B§mRNA-1273-P201DVmRNA-1273-P201-US206-1003US2061003APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BímRNA-1273-P201DVmRNA-1273-P201-US206-1006US2061006AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-03BmRNA-1273-P201DVmRNA-1273-P201-US206-1006US2061006A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-10A€mRNA-1273-P201DVmRNA-1273-P201-US206-1008US2061008AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04A mRNA-1273-P201DVmRNA-1273-P201-US206-1008US2061008A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BTmRNA-1273-P201DVmRNA-1273-P201-US206-1008US2061008A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BomRNA-1273-P201DVmRNA-1273-P201-US206-1008US2061008A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1008US2061008APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1008US2061008A`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BîmRNA-1273-P201DVmRNA-1273-P201-US206-1009US2061009AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BTmRNA-1273-P201DVmRNA-1273-P201-US206-1009US2061009A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BomRNA-1273-P201DVmRNA-1273-P201-US206-1009US2061009A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1009US2061009A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1009US2061009APP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BNmRNA-1273-P201DVmRNA-1273-P201-US206-1010US2061010AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BTmRNA-1273-P201DVmRNA-1273-P201-US206-1010US2061010A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BomRNA-1273-P201DVmRNA-1273-P201-US206-1010US2061010A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1010US2061010A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1010US2061010APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BímRNA-1273-P201DVmRNA-1273-P201-US206-1010US2061010A`P10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BNmRNA-1273-P201DVmRNA-1273-P201-US206-1011US2061011AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BTmRNA-1273-P201DVmRNA-1273-P201-US206-1011US2061011A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-21BomRNA-1273-P201DVmRNA-1273-P201-US206-1011US2061011A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1011US2061011A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1011US2061011APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BímRNA-1273-P201DVmRNA-1273-P201-US206-1011US2061011A`P10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BNmRNA-1273-P201DVmRNA-1273-P201-US206-1013US2061013AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BRmRNA-1273-P201DVmRNA-1273-P201-US206-1013US2061013A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-23BomRNA-1273-P201DVmRNA-1273-P201-US206-1013US2061013A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1013US2061013A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-19B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1013US2061013APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BìmRNA-1273-P201DVmRNA-1273-P201-US206-1015US2061015AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BTmRNA-1273-P201DVmRNA-1273-P201-US206-1015US2061015A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-23BqmRNA-1273-P201DVmRNA-1273-P201-US206-1015US2061015A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-19B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1015US2061015A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1015US2061015APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BímRNA-1273-P201DVmRNA-1273-P201-US206-1018US2061018AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-26BSmRNA-1273-P201DVmRNA-1273-P201-US206-1018US2061018A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-23BomRNA-1273-P201DVmRNA-1273-P201-US206-1018US2061018A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1018US2061018A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-19B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1019US2061019AP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BNmRNA-1273-P201DVmRNA-1273-P201-US206-1019US2061019A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-21B1mRNA-1273-P201DVmRNA-1273-P201-US206-1020US2061020AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-14B%mRNA-1273-P201DVmRNA-1273-P201-US206-1021US2061021AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-31BYmRNA-1273-P201DVmRNA-1273-P201-US206-1021US2061021A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-21B0mRNA-1273-P201DVmRNA-1273-P201-US206-1023US2061023AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-26BSmRNA-1273-P201DVmRNA-1273-P201-US206-1023US2061023A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-24BpmRNA-1273-P201DVmRNA-1273-P201-US206-1023US2061023A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1023US2061023A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-19B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1023US2061023APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BìmRNA-1273-P201DVmRNA-1273-P201-US206-1024US2061024AP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BNmRNA-1273-P201DVmRNA-1273-P201-US206-1024US2061024A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-22B2mRNA-1273-P201DVmRNA-1273-P201-US206-1024US2061024A0VACCINATION IS NOT ACCORDING TO THE PROTOCOL - SUBJECT WAS RANDOMIZED TO 100 MCG TREATMENT ARM AT DAY 1 BUT RECEIVED PLACEBO Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-06-03AmRNA-1273-P201DVmRNA-1273-P201-US206-1025US2061025AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-14BÃmRNA-1273-P201DVmRNA-1273-P201-US206-1025US2061025A P10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BNmRNA-1273-P201DVmRNA-1273-P201-US206-1025US2061025A0VACCINATION IS NOT ACCORDING TO THE PROTOCOL - SUBJECT US206-1025 WAS RANDOMIZED TO PLACEBO TREATMENT ARM BUT RECEIVED 100 MCG DOSE AT DAY 1 Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-06-03AmRNA-1273-P201DVmRNA-1273-P201-US206-1026US2061026AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-26BSmRNA-1273-P201DVmRNA-1273-P201-US206-1026US2061026A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-23BomRNA-1273-P201DVmRNA-1273-P201-US206-1026US2061026A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1026US2061026A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-17B¦mRNA-1273-P201DVmRNA-1273-P201-US206-1026US2061026APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BìmRNA-1273-P201DVmRNA-1273-P201-US206-1026US2061026A`P10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BLmRNA-1273-P201DVmRNA-1273-P201-US206-1027US2061027AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-31BXmRNA-1273-P201DVmRNA-1273-P201-US206-1027US2061027A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-23BomRNA-1273-P201DVmRNA-1273-P201-US206-1027US2061027A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1027US2061027A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-19B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1027US2061027APP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-26BìmRNA-1273-P201DVmRNA-1273-P201-US206-1032US2061032AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-23BomRNA-1273-P201DVmRNA-1273-P201-US206-1032US2061032A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-21B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1032US2061032A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-19B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1032US2061032A@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-25BëmRNA-1273-P201DVmRNA-1273-P201-US206-1032US2061032APP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-19BLmRNA-1273-P201DVmRNA-1273-P201-US206-1035US2061035AP05.02: SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (VACCINATION GIVEN OUT OF WINDOW EXCEPT IN THE CASES OF RESTRICTIONS DUE TO COVID-19 PANDEMIC, WHERE 2ND DOSE WILL BE ALLOWED UP TO +21 Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-07-20BmRNA-1273-P201DVmRNA-1273-P201-US206-1036US2061036AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-16BSmRNA-1273-P201DVmRNA-1273-P201-US206-1036US2061036A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-14BomRNA-1273-P201DVmRNA-1273-P201-US206-1037US2061037AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-19BVmRNA-1273-P201DVmRNA-1273-P201-US206-1037US2061037A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-16BqmRNA-1273-P201DVmRNA-1273-P201-US206-1037US2061037A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-11-11B‹mRNA-1273-P201DVmRNA-1273-P201-US206-1051US2061051AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing BLINDED TREATMENT 2020-06-30AmRNA-1273-P201DVmRNA-1273-P201-US206-1063US2061063AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B+mRNA-1273-P201DVmRNA-1273-P201-US206-1064US2061064AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-09-24BWmRNA-1273-P201DVmRNA-1273-P201-US206-1064US2061064A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-10-20BqmRNA-1273-P201DVmRNA-1273-P201-US206-1067US2061067AI06: PROCEDURE OR ASSESSMENT WAS NOT PERFORMED BY A DELEGATED AND/OR TRAINED PERSONNEL OR IMPROPER DELEGATION OF TASKS ICH/GCP Deviation Inv Qualifications/Agreements SCREENING 2020-07-23.mRNA-1273-P201DVmRNA-1273-P201-US206-1068US2061068AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-12-14B¨mRNA-1273-P201DVmRNA-1273-P201-US206-1068US2061068A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B+mRNA-1273-P201DVmRNA-1273-P201-US206-1068US2061068A0P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-25B9mRNA-1273-P201DVmRNA-1273-P201-US207-1001US2071001ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11328 (50 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02APmRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02A mRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-05APmRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002A0P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-16B.mRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002A@P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-07-27B9mRNA-1273-P201DVmRNA-1273-P201-US207-1002US2071002APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02A mRNA-1273-P201DVmRNA-1273-P201-US207-1003US2071003AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02A mRNA-1273-P201DVmRNA-1273-P201-US207-1003US2071003A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02A mRNA-1273-P201DVmRNA-1273-P201-US207-1004US2071004AP03.01: RECONSENT NOT COLLECTED FOR NEW ICF Protocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-20BNmRNA-1273-P201DVmRNA-1273-P201-US207-1005US2071005AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18BmRNA-1273-P201DVmRNA-1273-P201-US207-1005US2071005A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BJmRNA-1273-P201DVmRNA-1273-P201-US207-1005US2071005A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BJmRNA-1273-P201DVmRNA-1273-P201-US207-1005US2071005A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE PLACEBO DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18BmRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006A0I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-12BHmRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006A@P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - DISCREPANCY NOTED IN THE TIMINGS OF DOSE PREPARATION AND DOSE SYRINGE FILLING. ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-12BHmRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006A`SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE BPO DOSE NUMBER WAS NOT ENTERED CORRECTLY BY PI. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1006US2071006ApSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1007US2071007AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1007US2071007A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1012US2071012AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BImRNA-1273-P201DVmRNA-1273-P201-US207-1012US2071012A P03.01: RECONSENT NOT COLLECTED FOR NEW ICF Protocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-20BOmRNA-1273-P201DVmRNA-1273-P201-US207-1012US2071012A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - DISCREPANCY NOTED IN THE TIMINGS OF THE FILLING OF SYRINGE AND ADMINSTRATION OF IP. Protocol DeviationInv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BImRNA-1273-P201DVmRNA-1273-P201-US207-1013US2071013AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1013US2071013A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-09B&mRNA-1273-P201DVmRNA-1273-P201-US207-1013US2071013A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1014US2071014AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BImRNA-1273-P201DVmRNA-1273-P201-US207-1014US2071014A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BImRNA-1273-P201DVmRNA-1273-P201-US207-1016US2071016AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-03B>mRNA-1273-P201DVmRNA-1273-P201-US207-1016US2071016A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-03B>mRNA-1273-P201DVmRNA-1273-P201-US207-1017US2071017AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-30BmRNA-1273-P201DVmRNA-1273-P201-US207-1017US2071017A P03.01: EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED Protocol DeviationExclusion Criteria PART A FOLLOW-UP 2020-08-24BTmRNA-1273-P201DVmRNA-1273-P201-US207-1017US2071017A0P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-18BNmRNA-1273-P201DVmRNA-1273-P201-US207-1022US2071022AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BImRNA-1273-P201DVmRNA-1273-P201-US207-1022US2071022A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT COMPLETED CORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BImRNA-1273-P201DVmRNA-1273-P201-US207-1026US2071026AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-08AmRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-12A€mRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18AàmRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A0P05.01: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-07-10B$mRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A@P07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-10B$mRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029APP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationMissing Endpoint Assessments PART A FOLLOW-UP 2020-08-05B>mRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A`P10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-01BYmRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029ApSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - SITE DID NOT NOTE THE INJECTION SITE INFORMATION ON THE 50UG DOSE PREPARATION AND ADMINSTRATION WORKSHEET. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18AàmRNA-1273-P201DVmRNA-1273-P201-US207-1029US2071029A€SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE INJECTION TIME FOR UNBLINDED SUBJECT WAS NOTED TO BE MISSING ON THE DOSE PREPARATION AND ADMINSITRATION WORKSHEET. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18AàmRNA-1273-P201DVmRNA-1273-P201-US207-1030US2071030AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-07-23B3mRNA-1273-P201DVmRNA-1273-P201-US207-1030US2071030A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-11BFmRNA-1273-P201DVmRNA-1273-P201-US207-1030US2071030A0P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-11BFmRNA-1273-P201DVmRNA-1273-P201-US207-1032US2071032AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1032US2071032A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1033US2071033AP05.01: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-07-09B mRNA-1273-P201DVmRNA-1273-P201-US207-1033US2071033A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-07BmRNA-1273-P201DVmRNA-1273-P201-US207-1037US2071037AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsSCREENING 2020-06-02ÁmRNA-1273-P201DVmRNA-1273-P201-US207-1037US2071037A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - IP ACCOUNTABILITY LOG WAS MISSING ENTRY OF "DATE USED" ICH/GCP Deviation Inv Record Keeping Source DocsSCREENING 2020-06-02ÁmRNA-1273-P201DVmRNA-1273-P201-US207-1038US2071038AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18AðmRNA-1273-P201DVmRNA-1273-P201-US207-1038US2071038A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-13B(mRNA-1273-P201DVmRNA-1273-P201-US207-1038US2071038A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18AðmRNA-1273-P201DVmRNA-1273-P201-US207-1038US2071038A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18AðmRNA-1273-P201DVmRNA-1273-P201-US207-1039US2071039AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18AàmRNA-1273-P201DVmRNA-1273-P201-US207-1039US2071039A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-05AmRNA-1273-P201DVmRNA-1273-P201-US207-1039US2071039A0P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-13B'mRNA-1273-P201DVmRNA-1273-P201-US207-1039US2071039A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18AàmRNA-1273-P201DVmRNA-1273-P201-US207-1041US2071041AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1041US2071041A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1041US2071041A0P07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationMissing Endpoint Assessments PART A FOLLOW-UP 2020-11-06BžmRNA-1273-P201DVmRNA-1273-P201-US207-1041US2071041A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1041US2071041APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US207-1042US2071042AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-21B0mRNA-1273-P201DVmRNA-1273-P201-US207-1042US2071042A P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-21B0mRNA-1273-P201DVmRNA-1273-P201-US207-1049US2071049AP03.01: RECONSENT NOT COLLECTED FOR NEW ICF Protocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-20BNmRNA-1273-P201DVmRNA-1273-P201-US207-1050US2071050AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BGmRNA-1273-P201DVmRNA-1273-P201-US207-1050US2071050A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT COMPLETED CORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BGmRNA-1273-P201DVmRNA-1273-P201-US207-1059US2071059AP05.01: VACCINATION IS NOT ACCORDING TO THE PROTOCOL , (IP (INCLUDING DILUENT AND SALINE) GIVEN THAT WAS NOT APPROPRIATE FOR USE (EXPIRED, TEMPERATURE DEVIATED UNREPORTED / QUARANTINED IP ETC), WRONGProtocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-07-07BmRNA-1273-P201DVmRNA-1273-P201-US207-1064US2071064AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BGmRNA-1273-P201DVmRNA-1273-P201-US207-1064US2071064A P02: SUBJECT DOES NOT MEET ENTRY CRITERIA (INC#) (INCLUSION CRITERIA NOT MET, BUT SUBJECT RANDOMIZED) Protocol DeviationInclusion Criteria PART A FOLLOW-UP 2020-10-14B„mRNA-1273-P201DVmRNA-1273-P201-US207-1064US2071064A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BGmRNA-1273-P201DVmRNA-1273-P201-US207-1066US2071066AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BCmRNA-1273-P201DVmRNA-1273-P201-US207-1066US2071066A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-03B8mRNA-1273-P201DVmRNA-1273-P201-US207-1066US2071066A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT COMPLETED CORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BCmRNA-1273-P201DVmRNA-1273-P201-US207-1067US2071067AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-13BFmRNA-1273-P201DVmRNA-1273-P201-US207-1068US2071068AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1068US2071068A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1069US2071069AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1069US2071069A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1070US2071070AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-15A€mRNA-1273-P201DVmRNA-1273-P201-US207-1071US2071071AP03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria BLINDED TREATMENT 2020-06-05AmRNA-1273-P201DVmRNA-1273-P201-US207-1072US2071072AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BGmRNA-1273-P201DVmRNA-1273-P201-US207-1072US2071072A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT COMPLETED CORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsPART A FOLLOW-UP 2020-08-14BGmRNA-1273-P201DVmRNA-1273-P201-US207-1073US2071073AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1073US2071073A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1074US2071074AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1074US2071074A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1081US2071081AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1081US2071081A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS NOT COMPLETED IN ITS ENTIRETY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-18A°mRNA-1273-P201DVmRNA-1273-P201-US207-1082US2071082AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1082US2071082A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - WORKSHEET "THAWING" SECTION NOT COMPLETED PROPERLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1083US2071083AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1083US2071083A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO CONFIRMED BY INITIALS WERE MISSING IN THE DOSE PREPARATION WORKSHEET. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1083US2071083A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL EXPIRATION DATE NOT ADDED. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1083US2071083A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1084US2071084AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1084US2071084A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO FORM NOT COMPLETELY PROPERLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1086US2071086AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-07-09AàmRNA-1273-P201DVmRNA-1273-P201-US207-1086US2071086A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1086US2071086A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1087US2071087AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1087US2071087A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-06A°mRNA-1273-P201DVmRNA-1273-P201-US207-1087US2071087A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - US2071087/US2071082 - WORKSHEET PAGE 1 NOT COMPLETED PROPERLY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1088US2071088AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1088US2071088A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) , THAT IS THE ONE WE CAN USE Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-27B mRNA-1273-P201DVmRNA-1273-P201-US207-1088US2071088A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1089US2071089AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1089US2071089A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1090US2071090AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B-mRNA-1273-P201DVmRNA-1273-P201-US207-1090US2071090A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B-mRNA-1273-P201DVmRNA-1273-P201-US207-1091US2071091AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1091US2071091A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) , THAT IS THE ONE WE CAN USE Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-10-05BfmRNA-1273-P201DVmRNA-1273-P201-US207-1091US2071091A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B0mRNA-1273-P201DVmRNA-1273-P201-US207-1092US2071092AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1092US2071092A P02: SUBJECT DOES NOT MEET ENTRY CRITERIA (INC#) (INCLUSION CRITERIA NOT MET, BUT SUBJECT RANDOMIZED) Protocol DeviationInclusion Criteria PART A FOLLOW-UP 2020-10-29B~mRNA-1273-P201DVmRNA-1273-P201-US207-1092US2071092A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B2mRNA-1273-P201DVmRNA-1273-P201-US207-1093US2071093AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-29AmRNA-1273-P201DVmRNA-1273-P201-US207-1094US2071094AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-08-04BmRNA-1273-P201DVmRNA-1273-P201-US207-1094US2071094A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-08-04BmRNA-1273-P201DVmRNA-1273-P201-US207-1096US2071096AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-05B#mRNA-1273-P201DVmRNA-1273-P201-US207-1096US2071096A P03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING 2020-06-24Á€mRNA-1273-P201DVmRNA-1273-P201-US207-1098US2071098AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-05B$mRNA-1273-P201DVmRNA-1273-P201-US207-1098US2071098A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B-mRNA-1273-P201DVmRNA-1273-P201-US207-1098US2071098A0P03.01: EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED Protocol DeviationExclusion Criteria BLINDED TREATMENT 2020-08-24B7mRNA-1273-P201DVmRNA-1273-P201-US207-1098US2071098A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO DOCUMENT HAS DOSE 2 NOT MARKED. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-14B-mRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B%mRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099A P03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria BLINDED TREATMENT 2020-07-07AmRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099A0P05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-08-04BmRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099A@P07: SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION (POST VACCINATION) Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-08-11B$mRNA-1273-P201DVmRNA-1273-P201-US207-1099US2071099APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - EXPIRATION DATE MISSING FOR THE NACL ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-08-12B%mRNA-1273-P201DVmRNA-1273-P201-US207-1101US2071101AP03.01: EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED Protocol DeviationExclusion Criteria BLINDED TREATMENT 2020-08-24B9mRNA-1273-P201DVmRNA-1273-P201-US207-1101US2071101A P05.01: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE Protocol DeviationStudy Treatment Admin/DispenseBLINDED TREATMENT 2020-08-31B@mRNA-1273-P201DVmRNA-1273-P201-US207-1101US2071101A0P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-12B-mRNA-1273-P201DVmRNA-1273-P201-US207-1104US2071104AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-07-21BmRNA-1273-P201DVmRNA-1273-P201-US207-1106US2071106AP05.02: SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (VACCINATION GIVEN OUT OF WINDOW EXCEPT IN THE CASES OF RESTRICTIONS DUE TO COVID-19 PANDEMIC, WHERE 2ND DOSE WILL BE ALLOWED UP TO +21 Protocol DeviationStudy Treatment Admin/DispensePART A FOLLOW-UP 2020-09-28BUmRNA-1273-P201DVmRNA-1273-P201-US207-1106US2071106A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-07-15A mRNA-1273-P201DVmRNA-1273-P201-US207-1106US2071106A0P09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) Protocol DeviationConcomitant Medication PART A FOLLOW-UP 2021-03-17BÿmRNA-1273-P201DVmRNA-1273-P201-US207-1106US2071106A@P10.01: SUBJECT DID NOT COMPLY WITH BLOOD DRAW SCHEDULE (VISIT PERFORMED OUF OF WINDOW - SAFETY LABS NOT COLLECTED AT D29, D57) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-10B$mRNA-1273-P201DVmRNA-1273-P201-US207-1106US2071106APP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-07-27BmRNA-1273-P201DVmRNA-1273-P201-US207-1106US2071106A`P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-10B$mRNA-1273-P201DVmRNA-1273-P201-US207-1106US2071106ApP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-17B+mRNA-1273-P201DVmRNA-1273-P201-US208-1001US2081001AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1001US2081001A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02APmRNA-1273-P201DVmRNA-1273-P201-US208-1001US2081001A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11320 AND 11319 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1002US2081002AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1002US2081002A P10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-29B¹mRNA-1273-P201DVmRNA-1273-P201-US208-1002US2081002A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11317 AND 11318 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1003US2081003AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1003US2081003A P05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER Protocol DeviationStudy Treatment Admin/DispensePART A FOLLOW-UP 2020-07-27B<mRNA-1273-P201DVmRNA-1273-P201-US208-1003US2081003A0P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-11AàmRNA-1273-P201DVmRNA-1273-P201-US208-1003US2081003A@P10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-29B¹mRNA-1273-P201DVmRNA-1273-P201-US208-1003US2081003APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11312 (50 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-05-29AmRNA-1273-P201DVmRNA-1273-P201-US208-1005US2081005AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1009US2081009AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1009US2081009A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-15AðmRNA-1273-P201DVmRNA-1273-P201-US208-1009US2081009A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11313 (50 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1014US2081014AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1014US2081014A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-15AðmRNA-1273-P201DVmRNA-1273-P201-US208-1014US2081014A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11316 AND 11322 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1015US2081015AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-01BmRNA-1273-P201DVmRNA-1273-P201-US208-1015US2081015A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1016US2081016AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1016US2081016A P03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING 2020-05-27ÁPmRNA-1273-P201DVmRNA-1273-P201-US208-1016US2081016A0P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-11A°mRNA-1273-P201DVmRNA-1273-P201-US208-1016US2081016A@P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-08-28BYmRNA-1273-P201DVmRNA-1273-P201-US208-1016US2081016APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11314 AND 11315 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1017US2081017AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments SCREENING 2020-05-28ÁPmRNA-1273-P201DVmRNA-1273-P201-US208-1017US2081017A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1019US2081019AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1019US2081019A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1019US2081019A0P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1019US2081019A@SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11329 AND 11330 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1023US2081023AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-11AmRNA-1273-P201DVmRNA-1273-P201-US208-1023US2081023A P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-07B#mRNA-1273-P201DVmRNA-1273-P201-US208-1023US2081023A0P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-08B$mRNA-1273-P201DVmRNA-1273-P201-US208-1023US2081023A@P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-08B$mRNA-1273-P201DVmRNA-1273-P201-US208-1025US2081025AI11: UNREPORTED AE IN CRF ICH/GCP Deviation Inv Safety Reporting (CRF) PART A FOLLOW-UP 2021-01-25BímRNA-1273-P201DVmRNA-1273-P201-US208-1025US2081025A P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-07B#mRNA-1273-P201DVmRNA-1273-P201-US208-1026US2081026AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-07B"mRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028A P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028A0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028A@P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1028US2081028APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11323 AND 11324 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033AI11: UNREPORTED AE IN CRF ICH/GCP Deviation Inv Safety Reporting (CRF) PART A FOLLOW-UP 2021-01-05BÚmRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-14B+mRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033A0P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-07B$mRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033A@P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments SCREENING 2020-05-29Á@mRNA-1273-P201DVmRNA-1273-P201-US208-1033US2081033APP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1035US2081035AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1035US2081035A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1035US2081035A0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11332 AND 11331 (100 MCG). ICH/GCP Deviation Inv Record Keeping Source DocsBLINDED TREATMENT 2020-06-02AmRNA-1273-P201DVmRNA-1273-P201-US208-1036US2081036AI11: UNREPORTED AE IN CRF ICH/GCP Deviation Inv Safety Reporting (CRF) PART A FOLLOW-UP 2020-11-20BªmRNA-1273-P201DVmRNA-1273-P201-US208-1036US2081036A I11: UNREPORTED AE IN CRF ICH/GCP Deviation Inv Safety Reporting (CRF) PART A FOLLOW-UP 2020-12-15BÃmRNA-1273-P201DVmRNA-1273-P201-US208-1036US2081036A0P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-15B*mRNA-1273-P201DVmRNA-1273-P201-US208-1036US2081036A@P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-11-05B›mRNA-1273-P201DVmRNA-1273-P201-US208-1038US2081038AP05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER Protocol DeviationStudy Treatment Admin/DispensePART A FOLLOW-UP 2020-08-10B@mRNA-1273-P201DVmRNA-1273-P201-US208-1039US2081039AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-09-04BYmRNA-1273-P201DVmRNA-1273-P201-US208-1039US2081039A P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-08BmRNA-1273-P201DVmRNA-1273-P201-US208-1039US2081039A0P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-06-26BmRNA-1273-P201DVmRNA-1273-P201-US208-1041US2081041AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-07B"mRNA-1273-P201DVmRNA-1273-P201-US208-1041US2081041A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-04AmRNA-1273-P201DVmRNA-1273-P201-US208-1042US2081042AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-08BmRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045AP03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING 2020-06-01Á0mRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-06-11A€mRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045A0P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING Protocol DeviationMissing Endpoint Assessments BLINDED TREATMENT 2020-07-14B)mRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045A@P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-07B"mRNA-1273-P201DVmRNA-1273-P201-US208-1045US2081045APP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2021-01-07BÚmRNA-1273-P201DVmRNA-1273-P201-US208-1046US2081046AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-09-30BsmRNA-1273-P201DVmRNA-1273-P201-US208-1049US2081049AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-08BmRNA-1273-P201DVmRNA-1273-P201-US208-1051US2081051AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-08B"mRNA-1273-P201DVmRNA-1273-P201-US208-1051US2081051A P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-08B"mRNA-1273-P201DVmRNA-1273-P201-US208-1051US2081051A0P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-14B(mRNA-1273-P201DVmRNA-1273-P201-US208-1052US2081052AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-10-27B‘mRNA-1273-P201DVmRNA-1273-P201-US208-1054US2081054AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-06-22BmRNA-1273-P201DVmRNA-1273-P201-US208-1054US2081054A P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-08B"mRNA-1273-P201DVmRNA-1273-P201-US208-1058US2081058AP05.04: SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (2ND VACCINATION NOT GIVEN ) Protocol DeviationStudy Treatment Admin/DispensePART A FOLLOW-UP 2020-07-06BmRNA-1273-P201DVmRNA-1273-P201-US208-1058US2081058A P07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationMissing Endpoint Assessments PART A FOLLOW-UP 2020-06-22AðmRNA-1273-P201DVmRNA-1273-P201-US208-1058US2081058A0P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-07-14B%mRNA-1273-P201DVmRNA-1273-P201-US208-1058US2081058A@P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-06-22AðmRNA-1273-P201DVmRNA-1273-P201-US208-1063US2081063AI11: UNREPORTED AE IN CRF ICH/GCP Deviation Inv Safety Reporting (CRF) PART A FOLLOW-UP 2020-10-12BmRNA-1273-P201DVmRNA-1273-P201-US208-1063US2081063A P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-08BmRNA-1273-P201DVmRNA-1273-P201-US208-1064US2081064AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments PART A FOLLOW-UP 2020-08-25BOmRNA-1273-P201DVmRNA-1273-P201-US208-1065US2081065AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-08-24B<mRNA-1273-P201DVmRNA-1273-P201-US208-1066US2081066AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-08-25B=mRNA-1273-P201DVmRNA-1273-P201-US208-1066US2081066A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B/mRNA-1273-P201DVmRNA-1273-P201-US208-1069US2081069AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-24BmRNA-1273-P201DVmRNA-1273-P201-US208-1070US2081070AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) Protocol DeviationStudy Procedures/Assessments SCREENING 2020-06-12ÁàmRNA-1273-P201DVmRNA-1273-P201-US208-1076US2081076AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2021-01-27BÓmRNA-1273-P201DVmRNA-1273-P201-US208-1076US2081076A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-01AmRNA-1273-P201DVmRNA-1273-P201-US208-1077US2081077AP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-10-21BrmRNA-1273-P201DVmRNA-1273-P201-US208-1080US2081080AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-28B;mRNA-1273-P201DVmRNA-1273-P201-US208-1081US2081081AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-08-27B<mRNA-1273-P201DVmRNA-1273-P201-US208-1081US2081081A I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2021-01-27BÕmRNA-1273-P201DVmRNA-1273-P201-US208-1085US2081085AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing BLINDED TREATMENT 2020-08-26B7mRNA-1273-P201DVmRNA-1273-P201-US208-1085US2081085A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B(mRNA-1273-P201DVmRNA-1273-P201-US208-1088US2081088AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-31B=mRNA-1273-P201DVmRNA-1273-P201-US208-1092US2081092AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-28B:mRNA-1273-P201DVmRNA-1273-P201-US208-1092US2081092A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-06B$mRNA-1273-P201DVmRNA-1273-P201-US208-1097US2081097AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-28B;mRNA-1273-P201DVmRNA-1273-P201-US208-1097US2081097A P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-24BVmRNA-1273-P201DVmRNA-1273-P201-US208-1099US2081099AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-08-26B>mRNA-1273-P201DVmRNA-1273-P201-US208-1100US2081100AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2020-09-10BGmRNA-1273-P201DVmRNA-1273-P201-US208-1103US2081103AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1104US2081104AP03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING 2020-06-23ÁmRNA-1273-P201DVmRNA-1273-P201-US208-1104US2081104A P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1108US2081108AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-28B9mRNA-1273-P201DVmRNA-1273-P201-US208-1108US2081108A P03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) Protocol DeviationExclusion Criteria SCREENING 2020-06-23Á mRNA-1273-P201DVmRNA-1273-P201-US208-1108US2081108A0P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-09ApmRNA-1273-P201DVmRNA-1273-P201-US208-1110US2081110AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-28B9mRNA-1273-P201DVmRNA-1273-P201-US208-1112US2081112AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing BLINDED TREATMENT 2020-08-26B7mRNA-1273-P201DVmRNA-1273-P201-US208-1112US2081112A I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2021-01-27BÑmRNA-1273-P201DVmRNA-1273-P201-US208-1112US2081112A0P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B(mRNA-1273-P201DVmRNA-1273-P201-US208-1113US2081113AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent PART A FOLLOW-UP 2020-09-08B?mRNA-1273-P201DVmRNA-1273-P201-US208-1116US2081116AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) Protocol DeviationStudy Procedures/Assessments BLINDED TREATMENT 2020-07-07AmRNA-1273-P201DVmRNA-1273-P201-US208-1117US2081117AP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B%mRNA-1273-P201DVmRNA-1273-P201-US208-1118US2081118AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent PART A FOLLOW-UP 2020-08-28B;mRNA-1273-P201DVmRNA-1273-P201-US208-1119US2081119AP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) Protocol DeviationVisit Scheduling PART A FOLLOW-UP 2021-01-29BÐmRNA-1273-P201DVmRNA-1273-P201-US208-1119US2081119A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B%mRNA-1273-P201DVmRNA-1273-P201-US208-1120US2081120AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-08-26B9mRNA-1273-P201DVmRNA-1273-P201-US208-1121US2081121AP01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANProtocol DeviationInformed Consent BLINDED TREATMENT 2020-08-24B2mRNA-1273-P201DVmRNA-1273-P201-US208-1123US2081123AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2020-08-25B9mRNA-1273-P201DVmRNA-1273-P201-US208-1123US2081123A P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-11B+mRNA-1273-P201DVmRNA-1273-P201-US208-1129US2081129AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONICH/GCP Deviation ICF Process/Timing PART A FOLLOW-UP 2021-01-28BÓmRNA-1273-P201DVmRNA-1273-P201-US208-1129US2081129A P05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER Protocol DeviationStudy Treatment Admin/DispensePART A FOLLOW-UP 2020-08-31B=mRNA-1273-P201DVmRNA-1273-P201-US208-1129US2081129A0P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-07-08ApmRNA-1273-P201DVmRNA-1273-P201-US208-1129US2081129A@P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) Protocol DeviationVisit Scheduling BLINDED TREATMENT 2020-08-24B6