Public Health and Medical Professionals for Transparency Documents
As of November 2023, FDA has represented that the production of the biologic product file for Comirnaty (16 years of age and older) is complete. PHMPT is reviewing the production to determine: (1) whether the search FDA conducted appears adequate (in other words, did FDA produce everything expected from the product file concerning safety and efficacy of Comirnaty); and (2) whether there are any potentially improper withholdings or redactions.
If you believe there are improper redactions or withholdings, or if there are records missing, please fill out the form below.
Pfizer 16+ Documents
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File Name Date Produced File Size Link 125742_S112_M1_cover.pdf November 1, 2023 2 MB 125742_S111_M1_letter of authorization.pdf November 1, 2023 739 KB 125742_S111_M1_cover.pdf November 1, 2023 2 MB 125742_S111_M1_356h.pdf November 1, 2023 4 MB 125742_S80_M1_cover.pdf November 1, 2023 734 KB 125742_S63_M1_response 18aug2021.pdf November 1, 2023 2 MB 125742_S63_M1_cover.pdf November 1, 2023 2 MB 125742_S61_M1_response 17aug2021.pdf November 1, 2023 2 MB 125742_S61_M1_cover.pdf November 1, 2023 668 KB 125742_S60_M3_32s2_control critical steps manuf process.pdf November 1, 2023 2 MB STN 124742_Courtesy Copy_Pfizer BioNTech Comirnaty STN 125742 COVID 19 Vaccine Lot Notifications (2021).pdf November 1, 2023 200 KB FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdf November 1, 2023 69 KB 125742 0_20219009.P0.pdf November 1, 2023 889 KB 125742 0_20219008.P0.pdf November 1, 2023 882 KB 125742 0_20219007.P0.pdf November 1, 2023 832 KB 125742 0_20219006.PC1.pdf November 1, 2023 902 KB 125742 0_20219006.P0.pdf November 1, 2023 902 KB 125742 0_20219005.P0.pdf November 1, 2023 898 KB 125742 0_20219004.P0.pdf November 1, 2023 903 KB 125742 0_20219003.PC1.pdf November 1, 2023 898 KB 125742 0_20219003.P0.pdf November 1, 2023 897 KB 125742 0_20219002.PC1.pdf November 1, 2023 905 KB 125742 0_20219002.P0.pdf November 1, 2023 905 KB 125742 0_20219001.PC1.pdf November 1, 2023 912 KB 125742 0_20219001.P0.pdf November 1, 2023 912 KB 125742_S116_M1_lab 1448 1 0.pdf November 1, 2023 1 MB 125742_S112_S2_M3_32s2_control critical steps manuf process.pdf November 1, 2023 2 MB 125742_S59_M1_response 17aug2021.pdf November 1, 2023 1 MB 125742_S59_M1_cover.pdf November 1, 2023 672 KB 125742_S57_M3_32p3_manufacturer diluent.pdf November 1, 2023 2 MB 125742_S57_M1_response 16aug2021.pdf November 1, 2023 2 MB 125742_S57_M1_cover.pdf November 1, 2023 2 MB 125742_S56_M1_response 13aug2021.pdf November 1, 2023 2 MB 125742_S56_M1_cover.pdf November 1, 2023 672 KB 125742_S55_M3_32p8_stability summary.pdf November 1, 2023 3 MB 125742_S55_M3_32p8_stability data long term.pdf November 1, 2023 3 MB 125742_S55_M2_introduction.pdf November 1, 2023 11 MB 125742_S55_M2_drug product stability.pdf November 1, 2023 3 MB 125742_S55_M2_32p8_stability data accelerated.pdf November 1, 2023 3 MB 125742_S55_M1_cover.pdf November 1, 2023 767 KB 125742_S53_M1_response 13aug2021.pdf November 1, 2023 1 MB 125742_S53_M1_cover.pdf November 1, 2023 675 KB 125742_S50_M3_32r_comirnaty lot release template.pdf November 1, 2023 2 MB 125742_S50_M1_response 13aug2021.pdf November 1, 2023 2 MB 125742_S50_M1_cover.pdf November 1, 2023 2 MB 125742_S48_M1_response 06aug2021.pdf November 1, 2023 2 MB 125742_S60_M1_response 17aug2021.pdf November 1, 2023 2 MB 125742_S60_M1_cover.pdf November 1, 2023 2 MB 125742_S47_M1_response 11aug2021.pdf November 1, 2023 2 MB 125742_S47_M1_cover.pdf November 1, 2023 2 MB 125742_S44_M1_response 10aug2021.pdf November 1, 2023 2 MB 125742_S44_M1_cover.pdf November 1, 2023 2 MB 125742_S43_M3_32p3_manufacturers.pdf November 1, 2023 2 MB 125742_S43_M1_response 05aug2021.pdf November 1, 2023 2 MB 125742_S43_M1_cover.pdf November 1, 2023 2 MB 125742_S42_M3_32r_comirnaty lot release template.pdf November 1, 2023 709 KB 125742_S42_M1_response 04aug2021.pdf November 1, 2023 4 MB 125742_S42_M1_cover.pdf November 1, 2023 2 MB 125742_S40_M1_response 06aug2021.pdf November 1, 2023 2 MB 125742_S40_M1_cover.pdf November 1, 2023 2 MB 125742_S37_M1_response 05aug2021.pdf November 1, 2023 2 MB 125742_S37_M1_cover.pdf November 1, 2023 2 MB 125742_S36_M1_response 02aug2021.pdf November 1, 2023 2 MB 125742_S36_M1_cover.pdf November 1, 2023 2 MB 125742_S35_M1_response 04aug2021.pdf November 1, 2023 1 MB 125742_S35_M1_cover.pdf November 1, 2023 2 MB 125742_S48_M1_cover.pdf November 1, 2023 2 MB 125742_S47_M3_32p3_manufacturer diluent.pdf November 1, 2023 2 MB 125742_S34_M1_response 03aug2021.pdf November 1, 2023 1 MB 125742_S34_M1_cover.pdf November 1, 2023 668 KB 125742_S30_M1_response 26jul2021.pdf November 1, 2023 1 MB 125742_S30_M1_cover.pdf November 1, 2023 671 KB 125742_S26_M1_fda bnt cl.pdf November 1, 2023 996 KB 125742_S26_M1_cover.pdf November 1, 2023 718 KB 125742_S26_M1_andover 483 response.pdf November 1, 2023 1 MB 125742_S25_M1_response 26jul2021.pdf November 1, 2023 1 MB 125742_S25_M1_cover.pdf November 1, 2023 668 KB 125742_S22_M1_response 16jul2021.pdf November 1, 2023 1 MB 125742_S22_M1_cover.pdf November 1, 2023 678 KB 125742_S19_M1_response 02jul2021.pdf November 1, 2023 2 MB 125742_S19_M1_cover.pdf November 1, 2023 2 MB 125742_S17_M1_reponse 09jul2021.pdf November 1, 2023 2 MB 125742_S17_M1_cover.pdf November 1, 2023 674 KB 125742_S15_M3_32r_comirnaty lot release 16jul2021.pdf November 1, 2023 1 MB 125742_S15_M1_response 16jul2021 lrp samples.pdf November 1, 2023 1 MB 125742_S34_M3_32a3_excipient information nomenclature alc 0315.pdf November 1, 2023 2 MB 125742_S11_M3_32r_fd0809 coa.pdf November 1, 2023 836 KB 125742_S11_M3_32r_fc3184 coa.pdf November 1, 2023 836 KB 125742_S11_M3_32r_fc3181 coa.pdf November 1, 2023 840 KB 125742_S11_M3_32r_677365 1g a 010 coa.pdf November 1, 2023 636 KB 125742_S11_M3_32r_677315o 1g a 010 coa.pdf November 1, 2023 635 KB 125742_S11_M3_32r_677159p 1g a 010 coa.pdf November 1, 2023 636 KB 125742_S11_M3_32r_677100p 1g a 010 coa.pdf November 1, 2023 636 KB 125742_S11_M3_32r_21y513c2501 coa.pdf November 1, 2023 636 KB 125742_S11_M3_32r_21y513c2401 coa.pdf November 1, 2023 1 MB 125742_S11_M3_32r_21y513c2301 coa.pdf November 1, 2023 1 MB 125742_S11_M1_response 25jun2021 cmc.pdf November 1, 2023 2 MB 125742_S11_M1_cover.pdf November 1, 2023 2 MB 125742_S5_M1_response 20 may 2021 facilities.pdf November 1, 2023 1 MB 125742_S5_M1_cover.pdf November 1, 2023 725 KB 125742_S15_M1_cover.pdf November 1, 2023 675 KB 125742_S11_M3_32r_pf 07302048 dp rm coa.pdf November 1, 2023 634 KB 125742_S2_M3_32s4_analytical procedure overview.pdf November 1, 2023 2 MB 125742_S2_M3_32s2_manufacturer.pdf November 1, 2023 2 MB 125742_S2_M3_32s2_control critical steps manuf process.pdf November 1, 2023 2 MB 125742_S2_M3_32r_reg info manufacturing schedules.pdf November 1, 2023 2 MB 125742_S2_M3_32r_reg info lot release documentation package.pdf November 1, 2023 4 MB 125742_S2_M3_32p53_validation analytical procedures overview.pdf November 1, 2023 2 MB 125742_S2_M3_32p53_validation analytical procedure rt pcr.pdf November 1, 2023 2 MB 125742_S2_M3_32p53_validation analytical procedure cap gel electro.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure subvis particulate matter.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure rt pcr.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure overview.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure osmometry.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure endotoxin.pdf November 1, 2023 2 MB 125742_S2_M3_32p52_analytical procedure cap gel electro.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_stability summary.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_stability data thermal stress cycling.pdf November 1, 2023 3 MB 125742_S2_M3_32p8_stability data photostability.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_stability data long term.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_stability data accelerated.pdf November 1, 2023 2 MB 125742_S2_M3_32p8_postapproval stability.pdf November 1, 2023 2 MB 125742_S2_M3_32p5_specifications.pdf November 1, 2023 2 MB 125742_S2_M3_32p5_batch analyses.pdf November 1, 2023 3 MB 125742_S2_M3_32p4_novel excipients.pdf November 1, 2023 2 MB 125742_S2_M3_32p4_excipients human animal.pdf November 1, 2023 2 MB 125742_S2_M3_32p3_manufacturers.pdf November 1, 2023 2 MB 125742_S2_M3_32s4_validation analyt procedure overview.pdf November 1, 2023 2 MB 125742_S2_M3_32s4_specification.pdf November 1, 2023 2 MB 125742_S2_M3_32p3_control critical steps in process mon control overview.pdf November 1, 2023 2 MB 125742_S2_M3_32p2_pharmaceutical development introduction.pdf November 1, 2023 2 MB 125742_S2_M3_32p1_description and composition.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information structure alc 0315.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information structure alc 0159.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information nomenclature alc 0315.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information nomenclature alc 0159.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information excipients alc 0315.pdf November 1, 2023 2 MB 125742_S2_M3_32a3_excipient information excipients alc 0159.pdf November 1, 2023 2 MB 125742_S2_M3_32a2_adventitious agents puurs.pdf November 1, 2023 2 MB 125742_S2_M3_32a2_adventitious agents kalamazoo.pdf November 1, 2023 2 MB 125742_S2_M3_32a2_adventitious agents andover.pdf November 1, 2023 2 MB 125742_S2_M2_introduction.pdf November 1, 2023 2 MB 125742_S2_M2_drug product stability.pdf November 1, 2023 2 MB 125742_S2_M2_drug product reference stand or materials.pdf November 1, 2023 2 MB 125742_S2_M2_drug product description composition drug prod.pdf November 1, 2023 2 MB 125742_S2_M2_appendices adv agen safe val.pdf November 1, 2023 2 MB 125742_S1_M1_financial cert summary.pdf November 1, 2023 715 KB 125742_S1_M1_financial cert 3455.pdf November 1, 2023 2 MB 125742_S1_M1_1.9.4_ipsp agreed.pdf November 1, 2023 2 MB 125742_S1_M1_1.9.2_ped studies deferral req.pdf November 1, 2023 11 MB 138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdf November 1, 2023 1 MB 137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdf November 1, 2023 813 KB 136_BLA_125742_RNAcontent_InSupportTesting.pdf November 1, 2023 739 KB 135_Courtesy Copy_BLA 125742 0_November 8, 2021_Summary Basis for Regulatory Action COMIRNATY.pdf November 1, 2023 540 KB 134_Courtesy Copy_BLA 125742 0_Toxicology Review COMIRNATY.pdf November 1, 2023 4 MB 133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdf November 1, 2023 3 MB 132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdf November 1, 2023 1 MB 131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdf November 1, 2023 1 MB 125742_S2_M3_32p3_batch formula.pdf November 1, 2023 2 MB 127_Courtesy Copy_BLA 125742 0_CBER Sentinel Program Sufficiency Memo COMIRNATY.pdf November 1, 2023 164 KB 125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdf November 1, 2023 4 MB 124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.pdf November 1, 2023 1 MB 123_Courtesy Copy_BLA 125742 0_August 23, 2021 Approval Letter Comirnaty.pdf November 1, 2023 157 KB 122_BLA 125742 0_08 22 2021_Telecon_Labeling via FAX_e.pdf November 1, 2023 775 KB 121_Courtesy Copy_BLA 125742 0_Employee Officer List Memo, August 22, 2021 COMIRNATY.pdf November 1, 2023 25 KB 120_Courtesy Copy_BLA 125742 0_CBER CMC BLA Review Memo COMIRNATY.pdf November 1, 2023 1 MB 119_Courtesy Copy_BLA 125742 0_Real World Evidence BLA Memo COMIRNATY.pdf November 1, 2023 63 KB 118_1_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdf November 1, 2023 659 KB 117_2_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdf November 1, 2023 1 MB 116_BLA 125742 0_08 21 2021_Inspection Related_Establi.pdf November 1, 2023 2 MB 115_1_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdf November 1, 2023 789 KB 111_BLA 125742 0_08 21 2021_Telecon_Advice.pdf November 1, 2023 660 KB 110_1_Courtesy Copy_BLA 125742 0_Analytical Method Review Memo COMIRNATY.pdf November 1, 2023 308 KB 109_Courtesy Copy_2_BLA 125742 0_CMC Review Memo, August 21, 2021 COMIRNATY.pdf November 1, 2023 839 KB 108_BLA 125742 0_08 21 2021_Inspection Related_Inspect.pdf November 1, 2023 1 MB 107A_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf November 1, 2023 815 KB 107_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf November 1, 2023 806 KB 105_BLA 125742 0_08 20 2021_Telecon_Advice_Information.pdf November 1, 2023 761 KB 103_2_BLA 125742 0_08 20 2021_Memo_Test Results.pdf November 1, 2023 1 MB 102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdf November 1, 2023 1 MB 101_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Addendum Memo COMIRNATY.pdf November 1, 2023 145 KB 100A_BLA 125742 0_08 20 2021_Memo_Other.pdf November 1, 2023 1 MB 100_BLA 125742 0_08 20 2021_Memo_Other.pdf November 1, 2023 1 MB 99_BLA 125742 0_08 20 2021_Memo_Committee Memo_Labeli.pdf November 1, 2023 2 MB 95_BLA 125742 0_08 19 2021_Memo_Compliance Check Acce.pdf November 1, 2023 2 MB 94_Courtesy Copy_1_BLA 125742 0_Statistical Review COMIRNATY.pdf November 1, 2023 261 KB 93_Courtesy Copy_2_BLA 125742 0_Statistical Review COMIRNATY.pdf November 1, 2023 301 KB 92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdf November 1, 2023 2 MB 89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf November 1, 2023 743 KB 87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf November 1, 2023 1 MB 129_BLA 125742 0_08 30 2021_Telecon_Other.pdf November 1, 2023 638 KB 128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdf November 1, 2023 637 KB 49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdf November 1, 2023 766 KB 47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdf November 1, 2023 755 KB 46_2_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdf November 1, 2023 789 KB 45_BLA 125742 0_08 05 2021_Telecon_Advice.pdf November 1, 2023 801 KB 44_3_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf November 1, 2023 767 KB 43A_STN 125742.0 4AUG21 LRP FU IR 2.pdf November 1, 2023 2 MB 42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf November 1, 2023 773 KB 40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdf November 1, 2023 772 KB 39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdf November 1, 2023 784 KB 33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdf November 1, 2023 734 KB 32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdf November 1, 2023 890 KB 27_BLA 125742 0_07 19 2021_Telecon_Advice.pdf November 1, 2023 746 KB 26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdf November 1, 2023 789 KB 25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdf November 1, 2023 794 KB 21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdf November 1, 2023 722 KB 18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdf November 1, 2023 765 KB 15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdf November 1, 2023 819 KB 10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdf November 1, 2023 757 KB 9_IND_19736_491_29 Sep 2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdf November 1, 2023 716 KB 8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdf November 1, 2023 717 KB 8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdf November 1, 2023 1 MB 7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdf November 1, 2023 718 KB 6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdf November 1, 2023 717 KB 5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdf November 1, 2023 716 KB 4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdf November 1, 2023 717 KB 3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdf November 1, 2023 696 KB 3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdf November 1, 2023 747 KB 2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdf November 1, 2023 698 KB 1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdf November 1, 2023 697 KB 1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdf November 1, 2023 713 KB 86_BLA 125742 0_08 18 2021_Telecon_Advice.pdf November 1, 2023 984 KB 85_Courtesy Copy_BLA 125742 0_Statistical Review COMIRNATY.pdf November 1, 2023 127 KB 84_BLA 125742 0_08 18 2021_Memo_Committee Memo_Review.pdf November 1, 2023 706 KB 83_BLA 125742 0_08 17 2021_Telecon_Other.pdf November 1, 2023 770 KB 81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf November 1, 2023 760 KB 79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf November 1, 2023 753 KB 75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf November 1, 2023 717 KB 74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf November 1, 2023 746 KB 73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf November 1, 2023 1 MB 68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf November 1, 2023 690 KB 68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf November 1, 2023 710 KB 68_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf November 1, 2023 753 KB 66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf November 1, 2023 794 KB 65_BLA 125742 0_08 13 2021_Memo_Request For Complianc.pdf November 1, 2023 864 KB 64_Courtesy Copy_BLA 125742 0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 COMIRNATY.pdf November 1, 2023 81 KB 62_BLA 125742 0_08 12 2021_Memo_Committee Memo_Requir.pdf November 1, 2023 1 MB 61_BLA 125742 0_08 11 2021_Telecon_Other.pdf November 1, 2023 719 KB 60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdf November 1, 2023 764 KB 58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdf November 1, 2023 755 KB 55_BLA 125742 0_08 09 2021_Telecon_Advice.pdf November 1, 2023 2 MB 54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdf November 1, 2023 1 MB 53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdf November 1, 2023 765 KB 52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdf November 1, 2023 1 MB 51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdf November 1, 2023 279 KB 19736_S0214_M1_cover.pdf October 1, 2023 716 KB 3_PM_S89_BLA 125742 5_09 21 2021_Telecon_Other.pdf October 1, 2023 724 KB 019736_S387_M5_c4591008 interim protocol deviations.pdf October 1, 2023 633 KB 125742_S5_M3_requirements travel belgium.pdf October 1, 2023 635 KB 125742_S5_M3_guidelines travel red zone belgium.pdf October 1, 2023 643 KB 019736_S70_M5_vr mqr 10211 10212 dlq.pdf October 1, 2023 663 KB 019736_S387_M5_c4591012 interim sponsor signature.pdf October 1, 2023 664 KB 019736_S157_M1_cover.pdf October 1, 2023 668 KB 019736_S387_M5_c4591008 interim excluded subjects.pdf October 1, 2023 684 KB 19736_S0289_M1_cover.pdf October 1, 2023 687 KB 19736_S0185_M1_cover.pdf October 1, 2023 687 KB 019736_S70_M1_cover.pdf October 1, 2023 689 KB 19736_S0369_M1_cover.pdf October 1, 2023 704 KB 019736_S70_M5_vr mqr 10211 10212 pq.pdf October 1, 2023 708 KB 19736_S0335_M1_cover.pdf October 1, 2023 735 KB 19736_S0408_M1_cover.pdf October 1, 2023 736 KB 19736_S0366_M1_cover.pdf October 1, 2023 736 KB 19736_S0453_M1_cover.pdf October 1, 2023 739 KB 125742_2_BLA 125742 0_05 18 2021_Telecon_Information Reques.pdf October 1, 2023 742 KB 19736_S0491_M1_cover.pdf October 1, 2023 742 KB 125742_S2_M5_5.4_who 2005.pdf October 1, 2023 747 KB 125742_S2_M5_5.4_who 2019.pdf October 1, 2023 747 KB 019736_S414_M1_cover.pdf October 1, 2023 753 KB 019736_S222_M1_cover.pdf October 1, 2023 754 KB 019736_S488_M1_cover.pdf October 1, 2023 756 KB 019736_S196_M1_cover.pdf October 1, 2023 759 KB 019736_S444_M5_c4591007 p2 3 older child assent lower dose eval.pdf October 1, 2023 773 KB 5_PM_S102_1_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdf October 1, 2023 782 KB 6_PM_S102_2_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdf October 1, 2023 783 KB 019736_S444_M5_c4591007 p1 older children assent lower dose eval icd.pdf October 1, 2023 786 KB 19736_S0243_M1_cover.pdf October 1, 2023 733 KB 019736_S387_M5_c4591008 interim sponsor signature.pdf October 1, 2023 824 KB 19736_S0185_M1_1571.pdf October 1, 2023 827 KB 7_PM_S102_BLA 125742 8_09 29 2021_Letter_Waiver 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