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Pfizer’s Documents
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File Name Date Produced File Size Link FDA CBER 2021 5683 0674998 0678267 125742_S1_M5_c4591001 S Supp D suppmb (xpt) January 3, 2023 444 KB FDA CBER 2021 5683 0671345 0674997 125742_S1_M5_c4591001 S D supplb (xpt) January 3, 2023 522 KB FDA CBER 2021 5683 0663135 0671344 125742_S1_M5_c4591001 A D adsympt (xpt) January 3, 2023 6 MB FDA CBER 2021 5683 0661614 0663134 125742_S1_M5_bnt162 01 S D lb (xpt) January 3, 2023 2 MB FDA CBER 2021 5683 0658060 0661613 125742_S1_M5_bnt162 01 S D face.xpt (xpt) January 3, 2023 2 MB FDA CBER 2021 5683 0654507 0658059 125742_S1_M5_bnt162 01 S Supp D suppface (xpt) January 3, 2023 612 KB FDA CBER 2021 5683 0652981 0654506 125742_S1_M5_bnt162 01 A D adlb (xpt) January 3, 2023 3 MB FDA CBER 2021 5683 0703843 0708840 125742_S1_M5_c4591001 S Supp D suppae (xpt) January 3, 2023 895 KB FDA CBER 2021 5683 0698920 0703842 125742_S1_M5_c4591001 S D suppae (xpt) January 3, 2023 873 KB FDA CBER 2021 5683 0681346 0688437 125742_S1_M5_c4591001 S D ds (xpt) January 3, 2023 3 MB FDA CBER 2021 5683 0678268 0681345 125742_S1_M5_c4591001 A D adds (xpt) January 3, 2023 8 MB FDA CBER 2021 5683 0652414 0652442 125742_S29_M1_lab 1448 0 2 pkg insert track (doc) January 3, 2023 529 KB FDA CBER 2021 5683 0652443 0652471 125742_S33_M5_5351_c4591001 508 efficacy tables (doc) January 3, 2023 53 KB FDA CBER 2021 5683 0652839 0652858 125742_S73_M1_lab 1448 0 8 annotated.docx January 3, 2023 521 KB FDA CBER 2021 5683 0652819 0652838 125742_S73_M1_lab 1448 0 8 pkg insert clean.docx January 3, 2023 515 KB FDA CBER 2021 5683 0652798 0652818 125742_S70_M1_lab 1448 0 7 pkg insert track.docx January 3, 2023 515 KB FDA CBER 2021 5683 0652777 0652797 125742_S70_M1_lab 1448 0 7 pkg insert clean.docx January 3, 2023 522 KB FDA CBER 2021 5683 0652756 0652776 125742_S70_M1_lab 1448 0 7 annotated.docx January 3, 2023 520 KB FDA CBER 2021 5683 0652735 0652755 125742_S68_M1_lab 1448 0 6 pkg insert track.docx January 3, 2023 515 KB FDA CBER 2021 5683 0652714 0652734 125742_S68_M1_lab 1448 0 6 pkg insert clean.docx January 3, 2023 514 KB FDA CBER 2021 5683 0652693 0652713 125742_S68_M1_lab 1448 0 6 annotated.docx January 3, 2023 520 KB FDA CBER 2021 5683 0652673 0652692 125742_S58_M1_lab 1448 0 5 pkg insert clean.docx January 3, 2023 514 KB FDA CBER 2021 5683 0652653 0652672 125742_S58_M1_lab 1448 0 5 pkg insert track.docx January 3, 2023 514 KB FDA CBER 2021 5683 0652633 0652652 125742_S58_M1_lab 1448 0 5 annotated.docx January 3, 2023 523 KB FDA CBER 2021 5683 0652612 0652632 125742_S51_M1_lab 1448 0 4 pkg insert clean.docx January 3, 2023 513 KB FDA CBER 2021 5683 0652591 0652611 125742_S51_M1_lab 1448 0 4 annotated.docx January 3, 2023 539 KB FDA CBER 2021 5683 0652570 0652590 125742_S51_M1_lab 1448 0 4 pkg insert track.docx January 3, 2023 522 KB FDA CBER 2021 5683 0652472 0652503 125742_S38_M5_c4591001 508 safety tables.docx January 3, 2023 73 KB FDA CBER 2021 5683 0652385 0652413 125742_S29_M1_lab 1448 0 2 pkg insert clean.docx January 3, 2023 535 KB FDA CBER 2021 5683 0652548 0652569 125742_S39_M1_lab 1448 0 3 pkg insert clean.docx January 3, 2023 760 KB FDA CBER 2021 5683 0652526 0652547 125742_S39_M1_lab 1448 0 3 annotated.docx January 3, 2023 1 MB FDA CBER 2021 5683 0652504 0652525 125742_S39_M1_lab 1448 0 3 pkg insert track.docx January 3, 2023 996 KB FDA CBER 2021 5683 0652961 0652980 125742_S80_M1_lab 1448 1 0 pkg insert clean.docx January 3, 2023 515 KB FDA CBER 2021 5683 0652941 0652960 125742_S79_M1_lab 1448 1 0 pkg insert clean.docx January 3, 2023 515 KB FDA CBER 2021 5683 0652920 0652940 125742_S76_M1_lab 1448 0 9 annotated.docx January 3, 2023 519 KB FDA CBER 2021 5683 0652899 0652919 125742_S76_M1_lab 1448 0 9 pkg insert track.docx January 3, 2023 515 KB FDA CBER 2021 5683 0652879 0652898 125742_S76_M1_lab 1448 0 9 pkg insert clean.docx January 3, 2023 515 KB FDA CBER 2021 5683 0652859 0652878 125742_S73_M1_lab 1448 0 8 pkg insert track.docx January 3, 2023 516 KB 125742_S70_M1_lab 1448 0 7 pkg insert track.pdf January 3, 2023 1 MB 125742_S70_M1_lab 1448 0 7 pkg insert clean.pdf January 3, 2023 1 MB 125742_S70_M1_lab 1448 0 7 annotated.pdf January 3, 2023 2 MB 125742_S68_M1_lab 1448 0 6 pkg insert track.pdf January 3, 2023 1 MB 125742_S68_M1_lab 1448 0 6 pkg insert clean.pdf January 3, 2023 1 MB 125742_S68_M1_lab 1448 0 6 annotated.pdf January 3, 2023 3 MB 125742_S80_M1_lab 1448 1 0 pkg insert clean.pdf January 3, 2023 875 KB 125742_S79_M1_lab 1448 1 0 pkg insert clean.pdf January 3, 2023 875 KB 125742_S76_M1_lab 1448 0 9 pkg insert track.pdf January 3, 2023 1 MB 125742_S76_M1_lab 1448 0 9 pkg insert clean.pdf January 3, 2023 1 MB 125742_S76_M1_lab 1448 0 9 annotated.pdf January 3, 2023 1 MB 125742_S73_M1_lab 1448 0 8 pkg insert track.pdf January 3, 2023 1 MB 125742_S73_M1_lab 1448 0 8 pkg insert clean.pdf January 3, 2023 1 MB 125742_S73_M1_lab 1448 0 8 annotated.pdf January 3, 2023 3 MB 125742_S64_M1_carton com195lpus puurs.pdf January 3, 2023 178 KB 125742_S64_M1_carton com195lkz kzoo.pdf January 3, 2023 135 KB 125742_S64_M1_carton com25ctpus puurs.pdf January 3, 2023 242 KB 125742_S64_M1_carton com25ctkz kzoo.pdf January 3, 2023 217 KB 125742_S58_M1_lab 1448 0 5 pkg insert track.pdf January 3, 2023 879 KB 125742_S58_M1_lab 1448 0 5 pkg insert clean.pdf January 3, 2023 878 KB 125742_S58_M1_lab 1448 0 5 annotated.pdf January 3, 2023 3 MB 125742_S54_M1_carton com195lpus puurs.pdf January 3, 2023 179 KB 125742_S54_M1_carton com195lkz kzoo.pdf January 3, 2023 135 KB 125742_S54_M1_carton com25ctpus puurs.pdf January 3, 2023 691 KB 125742_S54_M1_carton com25ctkz kzoo.pdf January 3, 2023 218 KB 125742_S51_M5_5351_c4591001 followup table.pdf January 3, 2023 606 KB 125742_S51_M1_lab 1448 0 4 pkg insert track.pdf January 3, 2023 1 MB 125742_S51_M1_lab 1448 0 4 pkg insert clean.pdf January 3, 2023 1 MB 125742_S51_M1_lab 1448 0 4 annotated.pdf January 3, 2023 4 MB 125742_S64_M1_sticker comdilrm.pdf January 3, 2023 180 KB 125742_S64_M1_label comvlabp puurs.pdf January 3, 2023 648 KB 125742_S64_M1_label comvlabkz kzoo.pdf January 3, 2023 49 KB 125742_S46_M1_carton com195lkz kzoo.pdf January 3, 2023 140 KB 125742_S46_M1_carton com25ctpus puurs.pdf January 3, 2023 241 KB 125742_S46_M1_carton com25ctkz kzoo.pdf January 3, 2023 217 KB 125742_S41_M1_c4591001 ve tables.pdf January 3, 2023 695 KB 125742_S39_M1_lab 1448 0 3 pkg insert track.pdf January 3, 2023 5 MB 125742_S39_M1_lab 1448 0 3 pkg insert clean.pdf January 3, 2023 5 MB 125742_S39_M1_lab 1448 0 3 annotated.pdf January 3, 2023 6 MB 125742_S39_M1_5351_c4591001 ve tables.pdf January 3, 2023 695 KB 125742_S38_M5_c4591001 508 safety tables.pdf January 3, 2023 928 KB 125742_S33_M5_5351_c4591001 508 efficacy tables.pdf January 3, 2023 821 KB 125742_S29_M1_lab 1448 0 2 pkg insert track.pdf January 3, 2023 1 MB 125742_S29_M1_lab 1448 0 2 pkg insert clean.pdf January 3, 2023 1 MB 125742_S29_M1_lab 1448 0 2 annotated.pdf January 3, 2023 3 MB 125742_S46_M1_sticker comdilrm.pdf January 3, 2023 56 KB 125742_S46_M1_label comvlabp puurs.pdf January 3, 2023 55 KB 125742_S46_M1_label comvlabkz kzoo.pdf January 3, 2023 49 KB 125742_S46_M1_carton com195lpus puurs.pdf January 3, 2023 179 KB 125742_S27_M1_response 29jul2021.pdf January 3, 2023 1 MB 125742_S21_M1_pvp track.pdf January 3, 2023 8 MB 125742_S21_M1_pharmacovigilance plan.pdf January 3, 2023 13 MB 125742_S16_M1_psp track.pdf January 3, 2023 922 KB 125742_S16_M1_ped studies deferral track change.pdf January 3, 2023 664 KB 125742_S13_M5_5351_c4591001 narrative 1226 12262255.pdf January 3, 2023 626 KB 125742_S13_M5_5351_c4591001 adae hiv listing.pdf January 3, 2023 683 KB 125742_S12_M1_waiver req preservative.pdf January 3, 2023 710 KB 125742_S12_M1_13jul2021 response.pdf January 3, 2023 1 MB 125742_S7_M1_response 08jun2021.pdf January 3, 2023 1 MB 125742_S6_M5_5351_c4591001 sequencing listings.pdf January 3, 2023 4 MB 125742_S1_M5_5351_c4591001 interim mth6 iec irb consent form.pdf January 3, 2023 10 MB 125742_S28_M1_response 22jul2021 followup.pdf January 3, 2023 767 KB 126_BLA 125742 0_08 23 2021_Memo_Other.pdf January 3, 2023 649 KB 114A_2_BLA_125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdf January 3, 2023 1 MB 106A_2_BLA_125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf January 3, 2023 1 MB 98A_BLA_125742 0_08 19 2021_Telecon_Labeling via FAX_e.pdf January 3, 2023 1 MB 91A_2_BLA_125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdf January 3, 2023 1 MB 82A_BLA_125742 0_08 17 2021_Telecon_Labeling via FAX_e.pdf January 3, 2023 1 MB 78_BLA_125742 0_08 17 2021_Memo_Other.pdf January 3, 2023 814 KB 77_BLA_125742 0_08 17 2021_Memo_Lot Release Clearance.pdf January 3, 2023 805 KB 72A_BLA_125742 0_08 13 2021_Telecon_Labeling via FAX_e.pdf January 3, 2023 1 MB 36A_BLA_125742 0_07 28 2021_Telecon_Labeling Target Cl.pdf January 3, 2023 1 MB 13_BLA_125742 0_07 02 2021_Committee Memo_APLB.pdf January 3, 2023 848 KB 10_BLA_125742 0_06 29 2021_Filing_Meeting_Summary.pdf January 3, 2023 713 KB 7_BLA_125742 0_06 17 2021_Memo_Other.pdf January 3, 2023 682 KB 4_BLA_125742 0_06 03 2021_First_Committee_Meeting_Summary.pdf January 3, 2023 772 KB 130_BLA _125742 0_09 01 2021_Committee Memo_Labeling.pdf January 3, 2023 771 KB FDA CBER 2021 5683 0688438 0698919 125742_S1_M5_c4591001 S D vs (xpt) January 3, 2023 8 MB FDA-CBER-2021-5683-0650114-0650115-125742_S1_M5_c4591001-S-D-ts.zip (xpt) December 1, 2022 4 KB FDA-CBER-2021-5683-0634075-0650113-125742_S1_M5_c4591001-S-D-suppex.zip (xpt) December 1, 2022 3 MB FDA-CBER-2021-5683-0633945-0634074-125742_S1_M5_bnt162-01-S-D-adva.zip (xpt) December 1, 2022 169 KB FDA-CBER-2021-5683-0633790-0633944-125742_S1_M5_bnt162-01-S-D-adcevd.zip (xpt) December 1, 2022 133 KB FDA-CBER-2021-5683-0623311-0633789-125742_S1_M5_c4591001-S-D-vs.zip (xpt) December 1, 2022 8.2 MB FDA-CBER-2021-5683-0616659-0623310-125742_S1_M5_c4591001-S-D-sv.zip (xpt) December 1, 2022 2.5 MB FDA-CBER-2021-5683-0600620-0616658-125742_S1_M5_c4591001-S-D-suppec.zip (xpt) December 1, 2022 3 MB FDA-CBER-2021-5683-0595944-0600619-125742_S1_M5_c4591001-S-D-se.zip (xpt) December 1, 2022 2 MB FDA-CBER-2021-5683-0595465-0595943-125742_S1_M5_bnt162-01-S-D-vs.zip (xpt) December 1, 2022 391 KB FDA-CBER-2021-5683-0594977-0595464-125742_S1_M5_bnt162-01-S-D-suppvs.zip (xpt) December 1, 2022 86 KB FDA-CBER-2021-5683-0593801-0593831-125742_S1_M5_bnt162-01-S-Supp-D-suppex.zip (xpt) November 1, 2022 7 KB FDA-CBER-2021-5683-0593770-0593800-125742_S1_M5_bnt162-01-S-Supp-D-suppec.zip (xpt) November 1, 2022 7 KB FDA-CBER-2021-5683-0593744-0593769-125742_S1_M5_bnt162-01-S-Supp-D-suppds.zip (xpt) November 1, 2022 5 KB FDA-CBER-2021-5683-0593665-0593743-125742_S1_M5_bnt162-01-S-Supp-D-suppcm.zip (xpt) November 1, 2022 21 KB FDA-CBER-2021-5683-0593621-0593664-125742_S1_M5_bnt162-01-S-Supp-D-suppae.zip (xpt) November 1, 2022 6 KB FDA-CBER-2021-5683-0593596-0593620-125742_S1_M5_bnt162-01-S-D-se.zip (xpt) November 1, 2022 12 KB FDA-CBER-2021-5683-0593482-0593595-125742_S1_M5_bnt162-01-S-D-pe.zip (xpt) November 1, 2022 45 KB FDA-CBER-2021-5683-0593327-0593481-125742_S1_M5_bnt162-01-S-D-ce.zip (xpt) November 1, 2022 106 KB FDA-CBER-2021-5683-0539816-0593326-125742_S1_M5_c4591001-01-S-Supp-D-face.zip (xpt) November 1, 2022 51 MB 125742_S1_M4_20256434.pdf November 1, 2022 22 MB FDA-CBER-2021-5683-0539337-0539815-125742_S1_M5_bnt162-01-A-D-advs.zip (xpt) October 3, 2022 862 KB FDA-CBER-2021-5683-0537914-0539336-125742_S1_M5_bnt162-01-A-D-adfacevd.zip (xpt) October 3, 2022 2 MB FDA-CBER-2021-5683-0484461-0537913-125742_S1_M5_c4591001-S-D-face.zip (xpt) October 3, 2022 52 MB FDA-CBER-2021-5683-0484452-0484460-125742_S1_M5_bnt162-01-S-D-ti.zip (xpt) October 3, 2022 5 KB FDA-CBER-2021-5683-0484442-0484451-125742_S1_M5_bnt162-01-S-D-ex.zip (xpt) October 3, 2022 7 KB FDA-CBER-2021-5683-0484419-0484441-125742_S1_M5_bnt162-01-S-D-eg.zip (xpt) October 3, 2022 16 KB FDA-CBER-2021-5683-0484409-0484418-125742_S1_M5_bnt162-01-S-D-ec.zip (xpt) October 3, 2022 6 KB FDA-CBER-2021-5683-0484384-0484408-125742_S1_M5_bnt162-01-S-D-ds.zip (xpt) October 3, 2022 10 KB FDA-CBER-2021-5683-0484379-0484383-125742_S1_M5_bnt162-01-S-D-dm.zip (xpt) October 3, 2022 7 KB FDA-CBER-2021-5683-0484356-0484378-125742_S1_M5_bnt162-01-S-D-xa.zip (xpt) October 3, 2022 18 KB FDA-CBER-2021-5683-0484342-0484355-125742_S1_M5_bnt162-01-S-D-ae.zip (xpt) October 3, 2022 33 KB FDA-CBER-2021-5683-0396200-0396213_125742_S1_M5_bnt162-01-A-D-adae.zip (xpt) September 1, 2022 64 KB FDA-CBER-2021-5683-0396214-0396222_125742_S1_M5_bnt162-01-S-D-cm.zip (xpt) September 1, 2022 15 KB FDA-CBER-2021-5683-0396223-0396227_125742_S1_M5_bnt162-01-S-D-dv.zip (xpt) September 1, 2022 6 KB FDA-CBER-2021-5683-0396228-0396233_125742_S1_M5_bnt162-01-S-D-rp.zip (xpt) September 1, 2022 4 KB FDA-CBER-2021-5683-0396234-0396238_125742_S1_M5_bnt162-01-S-D-suppdv.zip (xpt) September 1, 2022 3 KB FDA-CBER-2021-5683-0396239-0396241_125742_S1_M5_bnt162-01-S-D-suppeg.zip (xpt) September 1, 2022 1 KB 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-0396192_125742_S1_M5_c4591001-S-D-suppmo.zip (xpt) August 1, 2022 8.6 KB FDA-CBER-2021-5683-0396187_125742_S1_M5_c4591001-S-D-pr.zip (xpt) August 1, 2022 2.7 KB FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.zip (xpt) August 1, 2022 11 MB 125742_S2_M5_54_ezeanolue-e-2019.pdf August 1, 2022 40 MB FDA-CBER-2021-5683-0296904 to -0307543_125742_S1_M5_c4591001-S-D-suppce.zip (xpt) July 1, 2022 1 MB FDA-CBER-2021-5683-0286267 to -0296903_125742_S1_M5_c4591001-S-Supp-D-suppce.zip (xpt) July 1, 2022 2 MB FDA-CBER-2021-5683-0286072 to -0286266_125742_S1_M5_c4591001-S-Supp-D-relrec.zip (xpt) July 1, 2022 54 KB FDA-CBER-2021-5683-0285652 to -0286071_125742_S1_M5_c4591001-S-D-pe.zip (xpt) July 1, 2022 170 KB FDA-CBER-2021-5683-0285644 to -0285651_125742_S1_M5_c4591001-S-D-mo.zip (xpt) July 1, 2022 8 KB FDA-CBER-2021-5683-0282366 to -0285643_125742_S1_M5_c4591001-S-D-mb.zip (xpt) July 1, 2022 2 MB FDA-CBER-2021-5683-0282329 to -0282365_125742_S1_M5_c4591001-S-D-ie.zip (xpt) July 1, 2022 19 KB FDA-CBER-2021-5683-0282130 to -0282328_125742_S1_M5_c4591001-S-D-cm.zip (xpt) July 1, 2022 152 KB FDA-CBER-2021-5683-0225598 to -0282129_125742_S1_M5_c4591001-A-Supp-D-adfacevd.zip (xpt) July 1, 2022 84 MB FDA-CBER-2021-5683-0225100 to -0225597_125742_S1_M5_c4591001-A-D-adcm.zip (xpt) July 1, 2022 1 MB 125742_S2_M1_comvlabp vial puurs.pdf July 1, 2022 648 KB 125742_S2_M1_com195lpus carton puurs.pdf July 1, 2022 691 KB 125742_S2_M1_comvlabkz vial kzoo.pdf July 1, 2022 863 KB 125742_S2_M1_com25ctpus carton puurs.pdf July 1, 2022 672 KB 125742_S2_M1_com195lkz carton kzoo.pdf July 1, 2022 1,024 KB 125742_S2_M1_com25ctkz carton kzoo.pdf July 1, 2022 632 KB 125742_S1_M5_5351_c4591001 interim mth6 sap.pdf July 1, 2022 5 MB 125742_S1_M5_5351_c4591001 interim mth6 protocol deviations.pdf July 1, 2022 2 MB 125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdf July 1, 2022 5 MB 125742_S1_M5_5351_c4591001 interim mth6 excluded patients sensitive.pdf July 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125742_0_0 Section 2.7.4 summary-clin-safety.pdf December 13, 2021 6 MB STN 125742_0_0 Section 2.7.3 Summary of Clinical Efficacy.pdf December 13, 2021 3 MB STN 125742_0_0 Section 2.5 Clinical Overview.pdf December 13, 2021 4 MB CRFs for site 1055.pdf December 13, 2021 6 MB BATES-FDA-CBER-2021-5683-0002376_relrec.xpt December 13, 2021 567 KB BATES-FDA-CBER-2021-5683-0002380_ti.xpt December 13, 2021 37 KB BATES-FDA-CBER-2021-5683-0002379_te.xpt December 13, 2021 3 KB BATES-FDA-CBER-2021-5683-0002378_ta.xpt December 13, 2021 8 KB signed F21-5683 CBER Dec 13 2021 Response Letter.pdf December 13, 2021 207 KB BATES-FDA-CBER-2021-5683-0002377_supppr.xpt December 13, 2021 72 KB BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt December 13, 2021 5 KB BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt December 13, 2021 9 KB BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt December 13, 2021 9 KB 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