Pfizer 16+ Documents

Four days after the Pfizer vaccine was approved for ages 16+, PHMPT submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s COVID-19 vaccine biological product file. PHMPT has now sued the FDA for not releasing the data. Click below for court documents and for productions of Pfizer’s documents from the FDA.

TitleDateFile SizeLink
FDA CBER 2021 5683 1053274 1058198_125742_S1_M5_C4591001 S D mh.zip (xpt)September 1, 202311 MB
FDA CBER 2021 5683 1049660 1051265_125742_S1_M5_C4591001 S D ho.zip (xpt)September 1, 2023734 KB
FDA CBER 2021 5683 1051266 1053273_125742_S1_M5_C4591001 S D lb.zip (xpt)September 1, 20232 MB
FDA CBER 2021 5683 1045840 1049564_125742_S1_M5_C4591001 S D co.zip (xpt)September 1, 20231 MB
FDA CBER 2021 5683 1049565 1049659_125742_S1_M5_C4591001 S D faho.zip (xpt)September 1, 202380 KB
FDA CBER 2021 5683 1040915 1045839_125742_S1_M5_C4591001 A D admh.zip (xpt)September 1, 202323 MB
FDA CBER 2021 5683 1071968 1071995_125742_S6_M5_c45941001 S D xb.zip (xpt)September 1, 202325 KB
FDA CBER 2021 5683 1040914_125742_S1_M5_bnt162 01 S D mh.zip (xpt)September 1, 20236 KB
FDA CBER 2021 5683 1067563 1070765_125742_S6_M5_c4591001 S D ex.zip (xpt)September 1, 20232 MB
FDA CBER 2021 5683 1070766 1071967_125742_S6_M5_c45941001 S D dm.zip (xpt)September 1, 20231 MB
FDA CBER 2021 5683 1066333 1067534_125742_S6_M5_c4591001 A D adsl.zip (xpt)September 1, 20237 MB
FDA CBER 2021 5683 1067535 1067562_125742_S6_M5_c4591001 A D adxb.zip (xpt)September 1, 202347 KB
FDA CBER 2021 5683 1058199 1058203_125742_S1_M5_C4591001 S D suppie.zip (xpt)September 1, 20237 KB
FDA CBER 2021 5683 1058209 1060003_28A_2 c4591001 safety fa eff.xlsxSeptember 1, 20233 MB
FDA CBER 2021 5683 1060004 1060071_28B_3 bnt162 01.xlsxSeptember 1, 2023133 KB
FDA CBER 2021 5683 1060085_28E_IND27034 BNT162 01 AEACN is DRUG WITHDRAWN but no ADVERSE EVENT record in DS.xlsxSeptember 1, 202311 KB
FDA CBER 2021 5683 1071996 1072061_125742_S6_M5_define.xmlSeptember 1, 2023283 KB
FDA CBER 2021 5683 1072062 1072080_125742_S6_M5_define 1.xmlSeptember 1, 202374 KB
FDA CBER 2021 5683 1064475 1066330_28K_Part III CoreDF IND27034 c4591001 subset 2021 04 19T10 50.xlsxSeptember 1, 20233 MB
FDA CBER 2021 5683 1060090 1064473_28I_Part II CoreDF IND27034 12 15years.xlsxSeptember 1, 20237 MB
FDA CBER 2021 5683 1064474_28J_Part II IND27034 12 15years AEACN of DRUG WITHDRAWN but no DS ADVERSE EVENT record (1).xlsxSeptember 1, 202316 KB
FDA CBER 2021 5683 1060089_28H_IND27034 c4591001 safety fa eff AEACN is DRUG WITHDRAWN but no ADVERSE EVENT record in DS.xlsxSeptember 1, 202314 KB
FDA CBER 2021 5683 1060086 1060087_28F_IND27034 BNT162 01 Multiple baseline records in LB.xlsxSeptember 1, 202326 KB
FDA CBER 2021 5683 1060088_28G_IND27034 BNT162 01 Multiple baseline records in VS.xlsxSeptember 1, 202316 KB
125742_S1_M5_CRF_c4591001 1095 10951228.pdfSeptember 1, 20233 MB
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125742_S1_M5_CRF_c4591001 1093 10931067.pdfSeptember 1, 20231 MB
125742_S54_M1_vial rl 7302 rocky mount hospira.pdfSeptember 1, 2023695 KB
125742_S79_M1_cover.pdfSeptember 1, 20232 MB
125742_S54_M1_diluent carton fresenius kabi.pdfSeptember 1, 2023730 KB
125742_S54_M1_diluent vial fresenius kabi.pdfSeptember 1, 2023717 KB
125742_S38_M1_response 22jul2021.pdfSeptember 1, 20232 MB
125742_S54_M1_carton ca 7114 rocky mount hospira.pdfSeptember 1, 2023679 KB
125742_S38_M1_cover.pdfSeptember 1, 20232 MB
125742_S6_M5_adrg.pdfSeptember 1, 2023776 KB
125742_S6_M5_csdrg.pdfSeptember 1, 2023814 KB
125742_S1_M5_CRF_c4591001 1095 10951256.pdfSeptember 1, 20231 MB
125742_S6_M5_acrf.pdfSeptember 1, 20233 MB
106_2_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023822 KB
104A_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdfSeptember 1, 2023675 KB
104B_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdfSeptember 1, 2023675 KB
97_1_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdfSeptember 1, 2023785 KB
98_BLA 125742 0_08 19 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023784 KB
104_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdfSeptember 1, 2023747 KB
91_2_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023754 KB
96_2_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdfSeptember 1, 2023756 KB
88_2_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfSeptember 1, 2023746 KB
90_1_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023810 KB
76_BLA 125742 0_08 16 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023793 KB
80_2_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfSeptember 1, 2023782 KB
82_BLA 125742 0_08 17 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023731 KB
71_6_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfSeptember 1, 2023790 KB
72_BLA 125742 0_08 13 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023753 KB
69_1_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfSeptember 1, 2023802 KB
70_2_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfSeptember 1, 2023792 KB
125742_S1_M5_5351_c4591001 interim mth6 narrative sensitive.pdfSeptember 1, 202322 MB
67_3_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfSeptember 1, 2023866 KB
125742_S1_M5_5351_c4591001 interim mth6 compliance.pdfSeptember 1, 202394 MB
114_2_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023784 KB
112A_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdfSeptember 1, 2023766 KB
113_2_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdfSeptember 1, 2023874 KB
112_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdfSeptember 1, 2023747 KB
59_1_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdfSeptember 1, 2023759 KB
50_BLA 125742 0_08 06 2021_Memo_Committee Memo_APLB.pdfSeptember 1, 2023771 KB
56_BLA 125742 0_08 09 2021_Telecon_Information Reques.pdfSeptember 1, 2023755 KB
57_BLA 125742 0_08 09 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023789 KB
48A_BLA 125742 0_08 05 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 20233 MB
43_2_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfSeptember 1, 20231 MB
48_BLA 125742 0_08 05 2021_Telecon_Labeling via FAX_e.pdfSeptember 1, 2023750 KB
37_BLA 125742 0_07 29 2021_Telecon_Information Reques.pdfSeptember 1, 2023804 KB
38_1_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdfSeptember 1, 2023785 KB
41_1_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdfSeptember 1, 2023757 KB
35_BLA 125742 0_07 28 2021_Telecon_Information Reques.pdfSeptember 1, 2023776 KB
36_BLA 125742 0_07 28 2021_Telecon_Labeling Target Cl.pdfSeptember 1, 2023746 KB
31_2_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdfSeptember 1, 2023810 KB
34_2_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdfSeptember 1, 2023742 KB
29_BLA 125742 0_07 20 2021_Telecon_Information Reques.pdfSeptember 1, 2023748 KB
30_BLA 125742 0_07 22 2021_Telecon_Information Reques.pdfSeptember 1, 2023787 KB
30A_BLA 125742 0_07 22 2021_Telecon_Information Reques.pdfSeptember 1, 2023946 KB
28D_BLA 125742 0_07 20 2021_Memo_Review.pdfSeptember 1, 2023864 KB
28L_BLA 125742 0_07 20 2021_Memo_Review.pdfSeptember 1, 2023744 KB
28_BLA 125742 0_07 20 2021_Memo_Review.pdfSeptember 1, 2023697 KB
28C_BLA 125742 0_07 20 2021_Memo_Review.pdfSeptember 1, 2023783 KB
23_1_BLA 125742 0_07 15 2021_Telecon_Information Reques.pdfSeptember 1, 2023739 KB
24_2_BLA 125742 0_07 15 2021_Telecon_Information Reques.pdfSeptember 1, 2023733 KB
20_1_BLA 125742 0_07 13 2021_Telecon_Information Reques.pdfSeptember 1, 2023734 KB
22_BLA 125742 0_07 15 2021_Meeting Summary_Committee.pdfSeptember 1, 20231 MB
16_BLA 125742 0_07 06 2021_Telecon_Information Reques.pdfSeptember 1, 2023735 KB
17_BLA 125742 0_07 06 2021_Telecon_Advice_PNR Accepta.pdfSeptember 1, 2023728 KB
19_2_BLA 125742 0_07 13 2021_Telecon_Information Reques.pdfSeptember 1, 2023748 KB
12_BLA 125742 0_07 01 2021_Memo_Filing Checklist_RPM.pdfSeptember 1, 20231 MB
14_BLA 125742 0_07 02 2021_Telecon_Advice.pdfSeptember 1, 2023770 KB
9_2_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdfSeptember 1, 2023812 KB
11_BLA 125742 0_06 29 2021_Telecon_Information Reques.pdfSeptember 1, 2023701 KB
5_BLA 125742 0_06 08 2021_Telecon_Information Reques.pdfSeptember 1, 2023766 KB
6_BLA 125742 0_06 09 2021_Telecon_Information Reques.pdfSeptember 1, 2023732 KB
63_BLA 125742 0_08 12 2021_Telecon_Other.pdfSeptember 1, 2023691 KB
FDA CBER 2021 5683 1072126 1072170_125742_S6_M5_define2 0 0 2.zip (xsl)September 1, 202327 KB
FDA CBER 2021 5683 1072081 1072125_125742_S6_M5_define2 0 0.zip (xsl)September 1, 202327 KB
FDA-CBER-2021-5683-1007285-1007313_125742_S2_M1_lab-1448-0-1-pkg-insert-clean.docAugust 1, 2023533KB
125742_S1_M5_CRF_c4591001 1089 10891182.pdfAugust 1, 20234 MB
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FDA CBER 2021 5683 0768159 0768188_125742_S1_M4_38166_define2 0 0.zipMarch 1, 202314 KB
FDA CBER 2021 5683 0768189 0768226_125742_S1_M4_38166 D_bg.zipMarch 1, 202321 KB
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FDA CBER 2021 5683 0771520 0771559_125742_S1_M4_20gr142 D_suppfw.zipMarch 1, 20237 KB
125742_S1_M4_20gr142_nsdrg.pdfMarch 1, 2023818 KB
125742_S1_M4_4.2.3.2 38166.pdfMarch 1, 202321 MB
125742_S1_M4_38166_nsdrg.pdfMarch 1, 2023856 KB
FDA CBER 2021 5683 0764727 0765714 125742_S1_M5_c4591001 S Supp D ae supp.zipFebruary 1, 20232 MB
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125742_S1_M4_4.2.2 072424.pdfFebruary 1, 20232 MB
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125742_S1_M4_4.2.1 r 20 0211.pdfFebruary 1, 20232 MB
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125742_S1_M4_4.2.1 r 20 0085.pdfFebruary 1, 202323 MB
125742_S1_M2_2.6.6 toxicology written summary.pdfFebruary 1, 20232 MB
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125742_S1_M2_2.6.3.1 pharmacol tabulated summaryFebruary 1, 20232 MB
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125742_S1_M2_2.6.1 introduction.pdfFebruary 1, 20232 MB
125742_S1_M4_4.3 munster jv 2020.pdfFebruary 1, 20233 MB
125742_S1_M4_4.2.3.2 20gr142.pdfFebruary 1, 202318 MB
125742_S1_M4_4.2.2.4 043725.pdfFebruary 1, 202312 MB
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106A_2_BLA_125742-0_08-20-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S79_M1_lab-1448-1-0-pkg-insert-clean.pdfJanuary 3, 2023875 KB
114A_2_BLA_125742-0_08-21-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S80_M1_lab-1448-1-0-pkg-insert-clean.pdfJanuary 3, 2023875 KB
126_BLA 125742-0_08-23-2021_Memo_OtherJanuary 3, 2023649 KB
FDA-CBER-2021-5683-0652385-0652413-125742_S29_M1_lab-1448-0-2-pkg-insert-clean.docxJanuary 3, 2023535 KB
130_BLA _125742-0_09-01-2021_Committee Memo_Labeling.pdfJanuary 3, 2023771 KB
FDA-CBER-2021-5683-0652414-0652442-125742_S29_M1_lab-1448-0-2-pkg-insert-track.doc.zipJanuary 3, 2023529 KB
125742_S1_M5_5351_c4591001-interim-mth6-iec-irb-consent-form.pdfJanuary 3, 202310 MB
125742_S6_M5_5351_c4591001-sequencing-listings.pdfJanuary 3, 20234 MB
125742_S7_M1_response-08jun2021January 3, 20231 MB
125742_S12_M1_13jul2021-response.pdfJanuary 3, 20231 MB