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

Documents with a large file size are provided in a .zip file and will need to be uncompressed after download.

File NameDate ProducedFile SizeLink
125742_S112_M1_cover.pdfNovember 1, 20232 MB
125742_S111_M1_letter of authorization.pdfNovember 1, 2023739 KB
125742_S111_M1_cover.pdfNovember 1, 20232 MB
125742_S111_M1_356h.pdfNovember 1, 20234 MB
125742_S80_M1_cover.pdfNovember 1, 2023734 KB
125742_S63_M1_response 18aug2021.pdfNovember 1, 20232 MB
125742_S63_M1_cover.pdfNovember 1, 20232 MB
125742_S61_M1_response 17aug2021.pdfNovember 1, 20232 MB
125742_S61_M1_cover.pdfNovember 1, 2023668 KB
125742_S60_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
STN 124742_Courtesy Copy_Pfizer BioNTech Comirnaty STN 125742 COVID 19 Vaccine Lot Notifications (2021).pdfNovember 1, 2023200 KB
FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdfNovember 1, 202369 KB
125742 0_20219009.P0.pdfNovember 1, 2023889 KB
125742 0_20219008.P0.pdfNovember 1, 2023882 KB
125742 0_20219007.P0.pdfNovember 1, 2023832 KB
125742 0_20219006.PC1.pdfNovember 1, 2023902 KB
125742 0_20219006.P0.pdfNovember 1, 2023902 KB
125742 0_20219005.P0.pdfNovember 1, 2023898 KB
125742 0_20219004.P0.pdfNovember 1, 2023903 KB
125742 0_20219003.PC1.pdfNovember 1, 2023898 KB
125742 0_20219003.P0.pdfNovember 1, 2023897 KB
125742 0_20219002.PC1.pdfNovember 1, 2023905 KB
125742 0_20219002.P0.pdfNovember 1, 2023905 KB
125742 0_20219001.PC1.pdfNovember 1, 2023912 KB
125742 0_20219001.P0.pdfNovember 1, 2023912 KB
125742_S116_M1_lab 1448 1 0.pdfNovember 1, 20231 MB
125742_S112_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
125742_S59_M1_response 17aug2021.pdfNovember 1, 20231 MB
125742_S59_M1_cover.pdfNovember 1, 2023672 KB
125742_S57_M3_32p3_manufacturer diluent.pdfNovember 1, 20232 MB
125742_S57_M1_response 16aug2021.pdfNovember 1, 20232 MB
125742_S57_M1_cover.pdfNovember 1, 20232 MB
125742_S56_M1_response 13aug2021.pdfNovember 1, 20232 MB
125742_S56_M1_cover.pdfNovember 1, 2023672 KB
125742_S55_M3_32p8_stability summary.pdfNovember 1, 20233 MB
125742_S55_M3_32p8_stability data long term.pdfNovember 1, 20233 MB
125742_S55_M2_introduction.pdfNovember 1, 202311 MB
125742_S55_M2_drug product stability.pdfNovember 1, 20233 MB
125742_S55_M2_32p8_stability data accelerated.pdfNovember 1, 20233 MB
125742_S55_M1_cover.pdfNovember 1, 2023767 KB
125742_S53_M1_response 13aug2021.pdfNovember 1, 20231 MB
125742_S53_M1_cover.pdfNovember 1, 2023675 KB
125742_S50_M3_32r_comirnaty lot release template.pdfNovember 1, 20232 MB
125742_S50_M1_response 13aug2021.pdfNovember 1, 20232 MB
125742_S50_M1_cover.pdfNovember 1, 20232 MB
125742_S48_M1_response 06aug2021.pdfNovember 1, 20232 MB
125742_S60_M1_response 17aug2021.pdfNovember 1, 20232 MB
125742_S60_M1_cover.pdfNovember 1, 20232 MB
125742_S47_M1_response 11aug2021.pdfNovember 1, 20232 MB
125742_S47_M1_cover.pdfNovember 1, 20232 MB
125742_S44_M1_response 10aug2021.pdfNovember 1, 20232 MB
125742_S44_M1_cover.pdfNovember 1, 20232 MB
125742_S43_M3_32p3_manufacturers.pdfNovember 1, 20232 MB
125742_S43_M1_response 05aug2021.pdfNovember 1, 20232 MB
125742_S43_M1_cover.pdfNovember 1, 20232 MB
125742_S42_M3_32r_comirnaty lot release template.pdfNovember 1, 2023709 KB
125742_S42_M1_response 04aug2021.pdfNovember 1, 20234 MB
125742_S42_M1_cover.pdfNovember 1, 20232 MB
125742_S40_M1_response 06aug2021.pdfNovember 1, 20232 MB
125742_S40_M1_cover.pdfNovember 1, 20232 MB
125742_S37_M1_response 05aug2021.pdfNovember 1, 20232 MB
125742_S37_M1_cover.pdfNovember 1, 20232 MB
125742_S36_M1_response 02aug2021.pdfNovember 1, 20232 MB
125742_S36_M1_cover.pdfNovember 1, 20232 MB
125742_S35_M1_response 04aug2021.pdfNovember 1, 20231 MB
125742_S35_M1_cover.pdfNovember 1, 20232 MB
125742_S48_M1_cover.pdfNovember 1, 20232 MB
125742_S47_M3_32p3_manufacturer diluent.pdfNovember 1, 20232 MB
125742_S34_M1_response 03aug2021.pdfNovember 1, 20231 MB
125742_S34_M1_cover.pdfNovember 1, 2023668 KB
125742_S30_M1_response 26jul2021.pdfNovember 1, 20231 MB
125742_S30_M1_cover.pdfNovember 1, 2023671 KB
125742_S26_M1_fda bnt cl.pdfNovember 1, 2023996 KB
125742_S26_M1_cover.pdfNovember 1, 2023718 KB
125742_S26_M1_andover 483 response.pdfNovember 1, 20231 MB
125742_S25_M1_response 26jul2021.pdfNovember 1, 20231 MB
125742_S25_M1_cover.pdfNovember 1, 2023668 KB
125742_S22_M1_response 16jul2021.pdfNovember 1, 20231 MB
125742_S22_M1_cover.pdfNovember 1, 2023678 KB
125742_S19_M1_response 02jul2021.pdfNovember 1, 20232 MB
125742_S19_M1_cover.pdfNovember 1, 20232 MB
125742_S17_M1_reponse 09jul2021.pdfNovember 1, 20232 MB
125742_S17_M1_cover.pdfNovember 1, 2023674 KB
125742_S15_M3_32r_comirnaty lot release 16jul2021.pdfNovember 1, 20231 MB
125742_S15_M1_response 16jul2021 lrp samples.pdfNovember 1, 20231 MB
125742_S34_M3_32a3_excipient information nomenclature alc 0315.pdfNovember 1, 20232 MB
125742_S11_M3_32r_fd0809 coa.pdfNovember 1, 2023836 KB
125742_S11_M3_32r_fc3184 coa.pdfNovember 1, 2023836 KB
125742_S11_M3_32r_fc3181 coa.pdfNovember 1, 2023840 KB
125742_S11_M3_32r_677365 1g a 010 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_677315o 1g a 010 coa.pdfNovember 1, 2023635 KB
125742_S11_M3_32r_677159p 1g a 010 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_677100p 1g a 010 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_21y513c2501 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_21y513c2401 coa.pdfNovember 1, 20231 MB
125742_S11_M3_32r_21y513c2301 coa.pdfNovember 1, 20231 MB
125742_S11_M1_response 25jun2021 cmc.pdfNovember 1, 20232 MB
125742_S11_M1_cover.pdfNovember 1, 20232 MB
125742_S5_M1_response 20 may 2021 facilities.pdfNovember 1, 20231 MB
125742_S5_M1_cover.pdfNovember 1, 2023725 KB
125742_S15_M1_cover.pdfNovember 1, 2023675 KB
125742_S11_M3_32r_pf 07302048 dp rm coa.pdfNovember 1, 2023634 KB
125742_S2_M3_32s4_analytical procedure overview.pdfNovember 1, 20232 MB
125742_S2_M3_32s2_manufacturer.pdfNovember 1, 20232 MB
125742_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
125742_S2_M3_32r_reg info manufacturing schedules.pdfNovember 1, 20232 MB
125742_S2_M3_32r_reg info lot release documentation package.pdfNovember 1, 20234 MB
125742_S2_M3_32p53_validation analytical procedures overview.pdfNovember 1, 20232 MB
125742_S2_M3_32p53_validation analytical procedure rt pcr.pdfNovember 1, 20232 MB
125742_S2_M3_32p53_validation analytical procedure cap gel electro.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure subvis particulate matter.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure rt pcr.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure overview.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure osmometry.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure endotoxin.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure cap gel electro.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability summary.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability data thermal stress cycling.pdfNovember 1, 20233 MB
125742_S2_M3_32p8_stability data photostability.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability data long term.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability data accelerated.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_postapproval stability.pdfNovember 1, 20232 MB
125742_S2_M3_32p5_specifications.pdfNovember 1, 20232 MB
125742_S2_M3_32p5_batch analyses.pdfNovember 1, 20233 MB
125742_S2_M3_32p4_novel excipients.pdfNovember 1, 20232 MB
125742_S2_M3_32p4_excipients human animal.pdfNovember 1, 20232 MB
125742_S2_M3_32p3_manufacturers.pdfNovember 1, 20232 MB
125742_S2_M3_32s4_validation analyt procedure overview.pdfNovember 1, 20232 MB
125742_S2_M3_32s4_specification.pdfNovember 1, 20232 MB
125742_S2_M3_32p3_control critical steps in process mon control overview.pdfNovember 1, 20232 MB
125742_S2_M3_32p2_pharmaceutical development introduction.pdfNovember 1, 20232 MB
125742_S2_M3_32p1_description and composition.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information structure alc 0315.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information structure alc 0159.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information nomenclature alc 0315.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information nomenclature alc 0159.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information excipients alc 0315.pdfNovember 1, 20232 MB
125742_S2_M3_32a3_excipient information excipients alc 0159.pdfNovember 1, 20232 MB
125742_S2_M3_32a2_adventitious agents puurs.pdfNovember 1, 20232 MB
125742_S2_M3_32a2_adventitious agents kalamazoo.pdfNovember 1, 20232 MB
125742_S2_M3_32a2_adventitious agents andover.pdfNovember 1, 20232 MB
125742_S2_M2_introduction.pdfNovember 1, 20232 MB
125742_S2_M2_drug product stability.pdfNovember 1, 20232 MB
125742_S2_M2_drug product reference stand or materials.pdfNovember 1, 20232 MB
125742_S2_M2_drug product description composition drug prod.pdfNovember 1, 20232 MB
125742_S2_M2_appendices adv agen safe val.pdfNovember 1, 20232 MB
125742_S1_M1_financial cert summary.pdfNovember 1, 2023715 KB
125742_S1_M1_financial cert 3455.pdfNovember 1, 20232 MB
125742_S1_M1_1.9.4_ipsp agreed.pdfNovember 1, 20232 MB
125742_S1_M1_1.9.2_ped studies deferral req.pdfNovember 1, 202311 MB
138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdfNovember 1, 20231 MB
137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdfNovember 1, 2023813 KB
136_BLA_125742_RNAcontent_InSupportTesting.pdfNovember 1, 2023739 KB
135_Courtesy Copy_BLA 125742 0_November 8, 2021_Summary Basis for Regulatory Action COMIRNATY.pdfNovember 1, 2023540 KB
134_Courtesy Copy_BLA 125742 0_Toxicology Review COMIRNATY.pdfNovember 1, 20234 MB
133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdfNovember 1, 20233 MB
132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdfNovember 1, 20231 MB
131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdfNovember 1, 20231 MB
125742_S2_M3_32p3_batch formula.pdfNovember 1, 20232 MB
127_Courtesy Copy_BLA 125742 0_CBER Sentinel Program Sufficiency Memo COMIRNATY.pdfNovember 1, 2023164 KB
125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdfNovember 1, 20234 MB
124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.pdfNovember 1, 20231 MB
123_Courtesy Copy_BLA 125742 0_August 23, 2021 Approval Letter Comirnaty.pdfNovember 1, 2023157 KB
122_BLA 125742 0_08 22 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023775 KB
121_Courtesy Copy_BLA 125742 0_Employee Officer List Memo, August 22, 2021 COMIRNATY.pdfNovember 1, 202325 KB
120_Courtesy Copy_BLA 125742 0_CBER CMC BLA Review Memo COMIRNATY.pdfNovember 1, 20231 MB
119_Courtesy Copy_BLA 125742 0_Real World Evidence BLA Memo COMIRNATY.pdfNovember 1, 202363 KB
118_1_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdfNovember 1, 2023659 KB
117_2_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
116_BLA 125742 0_08 21 2021_Inspection Related_Establi.pdfNovember 1, 20232 MB
115_1_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023789 KB
111_BLA 125742 0_08 21 2021_Telecon_Advice.pdfNovember 1, 2023660 KB
110_1_Courtesy Copy_BLA 125742 0_Analytical Method Review Memo COMIRNATY.pdfNovember 1, 2023308 KB
109_Courtesy Copy_2_BLA 125742 0_CMC Review Memo, August 21, 2021 COMIRNATY.pdfNovember 1, 2023839 KB
108_BLA 125742 0_08 21 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
107A_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023815 KB
107_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023806 KB
105_BLA 125742 0_08 20 2021_Telecon_Advice_Information.pdfNovember 1, 2023761 KB
103_2_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
101_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Addendum Memo COMIRNATY.pdfNovember 1, 2023145 KB
100A_BLA 125742 0_08 20 2021_Memo_Other.pdfNovember 1, 20231 MB
100_BLA 125742 0_08 20 2021_Memo_Other.pdfNovember 1, 20231 MB
99_BLA 125742 0_08 20 2021_Memo_Committee Memo_Labeli.pdfNovember 1, 20232 MB
95_BLA 125742 0_08 19 2021_Memo_Compliance Check Acce.pdfNovember 1, 20232 MB
94_Courtesy Copy_1_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023261 KB
93_Courtesy Copy_2_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023301 KB
92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdfNovember 1, 20232 MB
89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 2023743 KB
87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
129_BLA 125742 0_08 30 2021_Telecon_Other.pdfNovember 1, 2023638 KB
128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdfNovember 1, 2023637 KB
49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdfNovember 1, 2023766 KB
47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
46_2_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
45_BLA 125742 0_08 05 2021_Telecon_Advice.pdfNovember 1, 2023801 KB
44_3_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023767 KB
43A_STN 125742.0 4AUG21 LRP FU IR 2.pdfNovember 1, 20232 MB
42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023773 KB
40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdfNovember 1, 2023772 KB
39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdfNovember 1, 2023784 KB
33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdfNovember 1, 2023734 KB
32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdfNovember 1, 2023890 KB
27_BLA 125742 0_07 19 2021_Telecon_Advice.pdfNovember 1, 2023746 KB
26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdfNovember 1, 2023722 KB
18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdfNovember 1, 2023819 KB
10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdfNovember 1, 2023757 KB
9_IND_19736_491_29 Sep 2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdfNovember 1, 2023716 KB
8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023718 KB
6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023716 KB
4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023717 KB
3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023696 KB
3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdfNovember 1, 2023747 KB
2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023698 KB
1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023697 KB
1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdfNovember 1, 2023713 KB
86_BLA 125742 0_08 18 2021_Telecon_Advice.pdfNovember 1, 2023984 KB
85_Courtesy Copy_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023127 KB
84_BLA 125742 0_08 18 2021_Memo_Committee Memo_Review.pdfNovember 1, 2023706 KB
83_BLA 125742 0_08 17 2021_Telecon_Other.pdfNovember 1, 2023770 KB
81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023760 KB
79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023717 KB
74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023746 KB
73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023690 KB
68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023710 KB
68_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
65_BLA 125742 0_08 13 2021_Memo_Request For Complianc.pdfNovember 1, 2023864 KB
64_Courtesy Copy_BLA 125742 0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 COMIRNATY.pdfNovember 1, 202381 KB
62_BLA 125742 0_08 12 2021_Memo_Committee Memo_Requir.pdfNovember 1, 20231 MB
61_BLA 125742 0_08 11 2021_Telecon_Other.pdfNovember 1, 2023719 KB
60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdfNovember 1, 2023764 KB
58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
55_BLA 125742 0_08 09 2021_Telecon_Advice.pdfNovember 1, 20232 MB
54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdfNovember 1, 2023279 KB
19736_S0214_M1_cover.pdfOctober 1, 2023716 KB
3_PM_S89_BLA 125742 5_09 21 2021_Telecon_Other.pdfOctober 1, 2023724 KB
019736_S387_M5_c4591008 interim protocol deviations.pdfOctober 1, 2023633 KB
125742_S5_M3_requirements travel belgium.pdfOctober 1, 2023635 KB
125742_S5_M3_guidelines travel red zone belgium.pdfOctober 1, 2023643 KB
019736_S70_M5_vr mqr 10211 10212 dlq.pdfOctober 1, 2023663 KB
019736_S387_M5_c4591012 interim sponsor signature.pdfOctober 1, 2023664 KB
019736_S157_M1_cover.pdfOctober 1, 2023668 KB
019736_S387_M5_c4591008 interim excluded subjects.pdfOctober 1, 2023684 KB
19736_S0289_M1_cover.pdfOctober 1, 2023687 KB
19736_S0185_M1_cover.pdfOctober 1, 2023687 KB
019736_S70_M1_cover.pdfOctober 1, 2023689 KB
19736_S0369_M1_cover.pdfOctober 1, 2023704 KB
019736_S70_M5_vr mqr 10211 10212 pq.pdfOctober 1, 2023708 KB
19736_S0335_M1_cover.pdfOctober 1, 2023735 KB
19736_S0408_M1_cover.pdfOctober 1, 2023736 KB
19736_S0366_M1_cover.pdfOctober 1, 2023736 KB
19736_S0453_M1_cover.pdfOctober 1, 2023739 KB
125742_2_BLA 125742 0_05 18 2021_Telecon_Information Reques.pdfOctober 1, 2023742 KB
19736_S0491_M1_cover.pdfOctober 1, 2023742 KB
125742_S2_M5_5.4_who 2005.pdfOctober 1, 2023747 KB
125742_S2_M5_5.4_who 2019.pdfOctober 1, 2023747 KB
019736_S414_M1_cover.pdfOctober 1, 2023753 KB
019736_S222_M1_cover.pdfOctober 1, 2023754 KB
019736_S488_M1_cover.pdfOctober 1, 2023756 KB
019736_S196_M1_cover.pdfOctober 1, 2023759 KB
019736_S444_M5_c4591007 p2 3 older child assent lower dose eval.pdfOctober 1, 2023773 KB
5_PM_S102_1_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdfOctober 1, 2023782 KB
6_PM_S102_2_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdfOctober 1, 2023783 KB
019736_S444_M5_c4591007 p1 older children assent lower dose eval icd.pdfOctober 1, 2023786 KB
19736_S0243_M1_cover.pdfOctober 1, 2023733 KB
019736_S387_M5_c4591008 interim sponsor signature.pdfOctober 1, 2023824 KB
19736_S0185_M1_1571.pdfOctober 1, 2023827 KB
7_PM_S102_BLA 125742 8_09 29 2021_Letter_Waiver Request.pdfOctober 1, 2023830 KB
11_PM_S136_BLA 125742 31_10 30 2021_Memo_Final Review Memo.pdfOctober 1, 2023835 KB
019736_S488_M5_c4591007 p2 3 older children assent troponin icd.pdfOctober 1, 2023837 KB
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019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdfOctober 1, 2023880 KB
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019736_S444_M5_c4591007 p2 3 adult participant icd lower dose eval.pdfOctober 1, 2023966 KB
019736_S444_M5_c4591007 p1 adult participant icd lower dose eval.pdfOctober 1, 2023974 KB
4_PM_S89_BLA 125742 5_09 22 2021_Telecon_Advice.pdfOctober 1, 2023983 KB
019736_S444_M5_c4591007 p2 3 parent icd lower dose eval.pdfOctober 1, 2023988 KB
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125742_S2_M1_356h.pdfOctober 1, 2023813 KB
1_PM_S85_BLA 125742 4_09 30 2021_Telecon_Advice.pdfOctober 1, 20231,014 KB
8_PM_S102_BLA 125742 8_09 29 2021_Telecon_Other.pdfOctober 1, 20231,016 KB
019736_S70_M5_vr sop lc 11120.pdfOctober 1, 20231,020 KB
019736_S488_M5_c4591007 p2 3 parent troponin icd.pdfOctober 1, 20231 MB
019736_S444_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdfOctober 1, 20231 MB
2_PM_S89_BLA 12572 5_09 10 2021_Telecon_Advice.pdfOctober 1, 20231 MB
019736_S222_M5_c4591020 protocol.pdfOctober 1, 20231 MB
019736_S268_M5_wi255886 protocol.pdfOctober 1, 20231 MB
019736_S268_M5_wi255886 sap.pdfOctober 1, 20231 MB
019736_S387_M5_c4591008 interim unplanned hospitalization.pdfOctober 1, 20231 MB
019736_S387_M5_c4591008 interim withdrawn subjects.pdfOctober 1, 20231 MB
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019736_S387_M5_c4591008 interim sample icd.pdfOctober 1, 20231 MB
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125742_S1_M5_5351_c4591001 fa interim investigators.pdfOctober 1, 20232 MB
125742_S1_M5_5351_c4591001 interim mth6 investigators.pdfOctober 1, 20232 MB
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019736_S488_M5_c4591007 p2 3 younger children assent troponin icd.pdfOctober 1, 20231,013 KB
019736_S444_M5_c4591007 p1 younger children assent lower dose eval icd.pdfOctober 1, 20232 MB
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019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose track.pdfOctober 1, 20232 MB
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019736_S70_M5_vr mqr 10212.pdfOctober 1, 20232 MB
019736_S470_M5_c4591009 protocol.pdfOctober 1, 20232 MB
019736_S31_M5_vr mqr 10214 att01 shi sop 10011.pdfOctober 1, 20232 MB
019736_S488_M5_c4591007 p2 3 parent addendum icd pbo cont selected dose.pdfOctober 1, 20232 MB
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125742_S75_M1_356h.pdfOctober 1, 20232 MB
019736_S70_M5_vr tm 10294.pdfOctober 1, 20232 MB
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019736_S387_M5_c4591012 interim abstract.pdfOctober 1, 20233 MB
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