Pfizer 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
125742_S1_M5_CRF_c4591001 1231 12315653.pdfJune 1, 20231 MB
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125742_S2_M1_loa dmf 9543 vials.pdfApril 3, 2023609 KB
125742_S2_M1_dca vaed.pdfApril 3, 2023744 KB
125742_S2_M1_diluent labeling proposal.pdfApril 3, 20232 MB
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125742_S1_M5_5351_c4591001 interim mth6 synopsis.pdfApril 3, 20234 MB
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125742_S1_M5_5314_vr mvr 10081.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10080 att 02.pdfApril 3, 20232 MB
FDA CBER 2021 5683 0775805 0776791_125742_S1_M5_C4591001 S D_ae.zipMarch 1, 20232 MB
FDA CBER 2021 5683 0776792_125742_S1_M5_C4591001 S D_dd.zipMarch 1, 20233 KB
FDA CBER 2021 5683 0776793 0777994_125742_S1_M5_C4591001 S D_dm.zipMarch 1, 20231 MB
FDA CBER 2021 5683 0774873 0775804_125742_S1_M5_C4591001 A D_adae.zipMarch 1, 20236 MB
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FDA CBER 2021 5683 0772469 0773670_125742_S1_M5_C4591001 A D_adsl.zipMarch 1, 20237 MB
FDA CBER 2021 5683 0772467 0772468_125742_S1_M5_bnt162 01 S D_ts.zipMarch 1, 20234 KB
FDA CBER 2021 5683 0772182 0772253_125742_S1_M5_bnt162 01 S D_is.zipMarch 1, 202377 KB
FDA CBER 2021 5683 0772254 0772289_125742_S1_M5_bnt162 01 S D_mb.zipMarch 1, 202318 KB
FDA CBER 2021 5683 0772290 0772417_125742_S1_M5_bnt162 01 S D_supplb.xpt.zipMarch 1, 202321 KB
FDA CBER 2021 5683 0772418 0772466_125742_S1_M5_bnt162 01 S D_sv.zipMarch 1, 202319 KB
FDA CBER 2021 5683 0772119_125742_S1_M4_20gr142 D_tx.zipMarch 1, 20231 KB
FDA CBER 2021 5683 0772120 0772124_125742_S1_M4_38166 D_tx.zipMarch 1, 20233 KB
FDA CBER 2021 5683 0772125 0772159_125742_S1_M4_38166 D_vs.zipMarch 1, 202312 KB
FDA CBER 2021 5683 0772160 0772181_125742_S1_M4_20gr142 D_vs.zipMarch 1, 202314 KB
FDA CBER 2021 5683 0772115_125742_S1_M4_20gr142 D_te.zipMarch 1, 2023749 B
FDA CBER 2021 5683 0772116_125742_S1_M4_38166 D_te.zipMarch 1, 2023779 B
FDA CBER 2021 5683 0772117_125742_S1_M4_20gr142 D_ts.zipMarch 1, 20232 KB
FDA CBER 2021 5683 0772118_125742_S1_M4_38166 D_ts.zipMarch 1, 20233 KB
FDA CBER 2021 5683 0772068 0772112_125742_S1_M4_20gr142 D_suppvs.zipMarch 1, 20237 KB
FDA CBER 2021 5683 0772113_125742_S1_M4_20gr142 D_ta.zipMarch 1, 2023827 B
FDA CBER 2021 5683 0772114_125742_S1_M4_38166 D_ta.zipMarch 1, 20231,014 B
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106A_2_BLA_125742-0_08-20-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
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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
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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
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125742_S21_M1_pharmacovigilance-planJanuary 3, 202313 MB
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FDA-CBER-2021-5683-0652443-0652471-125742_S33_M5_5351_c4591001-508-efficacy-tables.doc.zipJanuary 3, 202353 KB
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125742_S27_M1_response-29jul2021January 3, 20231 MB
FDA-CBER-2021-5683-0652504-0652525-125742_S39_M1_lab-1448-0-3-pkg-insert-track.doc.zipJanuary 3, 2023484 KB
125742_S28_M1_response-22jul2021-followup.pdfJanuary 3, 2023767 KB
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125742_S33_M5_5351_c4591001-508-efficacy-tables.pdfJanuary 3, 2023821 KB
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125742_S38_M5_c4591001-508-safety-tables.pdfJanuary 3, 2023928 KB
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125742_S39_M1_5351_c4591001-ve-tables.pdfJanuary 3, 2023695 KB
FDA-CBER-2021-5683-0652693-0652713-125742_S68_M1_lab-1448-0-6-annotated.docxJanuary 3, 2023520 KB
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125742_S46_M1_carton-com25ctkz-kzooJanuary 3, 2023217 KB
FDA-CBER-2021-5683-0652879-0652898-125742_S76_M1_lab-1448-0-9-pkg-insert-clean.docxJanuary 3, 2023515 KB
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125742_S46_M1_carton-com25ctpus-puurs.pdfJanuary 3, 2023241 KB
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125742_S46_M1_carton-com195lkz-kzoo.pdfJanuary 3, 2023140 KB
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125742_S46_M1_carton-com195lpus-puurs.pdfJanuary 3, 2023179 KB
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FDA-CBER-2021-5683-0703843-0708840-125742_S1_M5_c4591001-S-Supp-D-suppae.xpt.zipJanuary 3, 2023845 KB
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125742_S64_M1_carton-com25ctpus-puursJanuary 3, 2023242 KB
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4_BLA_125742-0_06-03-2021_First_Committee_Meeting_Summary.pdfJanuary 3, 2023772 KB
7_BLA_125742-0_06-17-2021_Memo_Other.pdfJanuary 3, 2023682 KB
10_BLA_125742-0_06-29-2021_Filing_Meeting_Summary.pdfJanuary 3, 2023713 KB
125742_S68_M1_lab-1448-0-6-pkg-insert-track.pdfJanuary 3, 20231 MB
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13_BLA_125742-0_07-02-2021_Committee Memo_APLB.pdfJanuary 3, 2023848 KB
125742_S70_M1_lab-1448-0-7-pkg-insert-track.pdfJanuary 3, 20231 MB
36A_BLA_125742-0_07-28-2021_Telecon_Labeling Target ClJanuary 3, 20231 MB
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72A_BLA_125742-0_08-13-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
77_BLA_125742-0_08-17-2021_Memo_Lot Release Clearance.pdfJanuary 3, 2023805 KB
78_BLA_125742-0_08-17-2021_Memo_Other.pdfJanuary 3, 2023814 KB
82A_BLA_125742-0_08-17-2021_Telecon_Labeling via FAX_eJanuary 3, 20231 MB
125742_S73_M1_lab-1448-0-8-pkg-insert-track.pdfJanuary 3, 20231 MB
91A_2_BLA_125742-0_08-18-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
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98A_BLA_125742-0_08-19-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
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125742_S1_M4_20256434.pdf.zipNovember 1, 202220 MB
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FDA CBER 2021 5683 0484461 0537913 125742_S1_M5_c4591001 S D face.zip (xpt)October 3, 202252 MB
FDA CBER 2021 5683 0539337 0539815 125742_S1_M5_bnt162 01 A D advs.xptOctober 3, 202216 MB
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FDA-CBER-2021-5683-0396255-0484341_125742_S1_M5_c4591001-S-Supp-D-suppface.xptSeptember 1, 2022467 MB
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FDA-CBER-2021-5683-0396199_125742_S1_M5_bnt162-01-S-D-tv.zipAugust 1, 20221 KB
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FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.xptAugust 1, 2022467 MB
125742_S2_M5_54_ezeanolue e 2019.pdfAugust 1, 202240 MB
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125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdfJuly 1, 20225 MB
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FDA CBER 2021 5683 0058615 to 0058652_125742_S1_M5_c4591001 S Supp define.xmlMay 2, 2022300 KB
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FDA CBER 2021 5683 0058479 to 0058594_125742_S1_M5_c4591001 S define.xmlMay 2, 2022904 KB
FDA CBER 2021 5683 0058459 to 0058478_125742_S1_M5_c4591001 A Supp define 2 0 0.xslMay 2, 2022183 KB
FDA CBER 2021 5683 0058316 to 0058458_125742_S1_M5_c4591001 A Supp define.xmlMay 2, 2022692 KB
FDA CBER 2021 5683 0065774 to 0066700_125742_S1_M5_c4591001 A D addv.xptMay 2, 202244 MB
FDA-CBER-2021-5683-0066701-to-0123167_125742_S1_M5_c4591001-A-D-adfacevd.zip (.xpt)May 2, 202279 MB
FDA-CBER-2021-5683-0123168-to-0126026_125742_S1_M5_c4591001-A-D-adva.zip (.xpt)May 2, 20226 MB
reissue_5.3.6 postmarketing experience.pdfApril 1, 2022958 KB
125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdfApril 1, 202228 MB
125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdfApril 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdfApril 1, 20225 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdfApril 1, 202259 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization.pdfApril 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-publications.pdfApril 1, 202210 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdfApril 1, 2022677 KB
125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdfApril 1, 20228 MB
125742_S1_M5_5351_c4591001-fa-interim-demographics.pdfApril 1, 202228 MB
125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdfApril 1, 2022869 KB
125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB
125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB
FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsxMarch 1, 202217 KB
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsxMarch 1, 202235 KB
FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsxMarch 1, 202284 KB
FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsxMarch 1, 202223 KB
FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsxMarch 1, 202218 KB
FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsxMarch 1, 202219 KB
FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsxMarch 1, 202222 KB
FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsxMarch 1, 202213 KB
FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsxMarch 1, 202229 KB
FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsxMarch 1, 202211 KB
FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsxMarch 1, 202224 KB
FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsxMarch 1, 202221 KB
FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsxMarch 1, 202212 KB
FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsxMarch 1, 202214 KB
FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xslMarch 1, 2022183 KB
FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xmlMarch 1, 20221 MB
FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txtMarch 1, 2022197 KB
FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txtMarch 1, 202229 KB
FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txtMarch 1, 202224 KB
FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txtMarch 1, 202275 KB
FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txtMarch 1, 202211 KB
FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txtMarch 1, 202249 KB
FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txtMarch 1, 202243 KB
FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txtMarch 1, 202245 KB
FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txtMarch 1, 202212 KB
FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txtMarch 1, 202272 KB
FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txtMarch 1, 202220 KB
FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txtMarch 1, 202219 KB
FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txtMarch 1, 202218 KB
FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txtMarch 1, 202281 KB
FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txtMarch 1, 202215 KB
FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txtMarch 1, 202215 KB
FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txtMarch 1, 202235 KB
FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txtMarch 1, 202214 KB
FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txtMarch 1, 202215 KB
FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txtMarch 1, 202232 KB
FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txtMarch 1, 2022156 KB
FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txtMarch 1, 202227 KB
FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txtMarch 1, 2022193 KB
125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-A-report-cci-rheumatic.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-report-cci-renal.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-report-cci-pulmonary.pdfMarch 1, 2022630 KB
125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdfMarch 1, 2022632 KB
125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdfMarch 1, 2022625 KB
125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdfMarch 1, 2022626 KB
125742_S1_M5_CRF_c4591001-1085-10851246.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851216.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851129.pdfMarch 1, 20222 MB
125742_S1_M5_CRF_c4591001-1085-10851116.pdfMarch 1, 20221 MB
125742_S1_M5_CRF_c4591001-1085-10851018.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdfMarch 1, 202217 MB
125742_S1_M5_c4591001-T-S-suppl-arg.pdfMarch 1, 2022738 KB
125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdfMarch 1, 2022667 KB
125742_S1_M5_c4591001-T-S-roadmap.pdfMarch 1, 2022703 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdfMarch 1, 2022627 KB
125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-dementia.pdfMarch 1, 2022626 KB
125742_S1_M5_c4591001-A-report-cci-chf.pdfMarch 1, 2022628 KB
125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdfMarch 1, 2022632 KB
125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdfMarch 1, 2022670 KB
125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdfMarch 1, 2022629 KB
125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdfMarch 1, 2022846 KB
125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdfMarch 1, 2022607 KB
125742_S1_M5_c4591001-A-comorbidity-categories.pdfMarch 1, 2022637 KB
125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdfMarch 1, 2022620 KB
125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdfMarch 1, 2022634 KB
125742_S1_M5_c4591001-A-report-cci-mild-liver.pdfMarch 1, 2022628 KB
125742_S1_M5_c4591001-A-report-cci-mi.pdfMarch 1, 2022624 KB
125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdfMarch 1, 2022636 KB
125742_S1_M5_c4591001-A-report-cci-lymphoma.pdfMarch 1, 2022640 KB
125742_S1_M5_c4591001-A-report-cci-leukemia.pdfMarch 1, 2022631 KB
125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdfMarch 1, 2022626 KB
125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdfMarch 1, 202237 MB
125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdfMarch 1, 202213 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol.pdfMarch 1, 202231 MB
125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdfMarch 1, 20225 MB
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdfMarch 1, 202212 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdfMarch 1, 202216 MB
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-errata.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdfMarch 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-compliance.pdfMarch 1, 20222 MB
125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdfMarch 1, 2022889 KB
125742_S1_M5_c4591001-A-bmi-12-15-scale.pdfMarch 1, 2022627 KB
125742_S1_M5_c4591001-A-adrg.pdfMarch 1, 20222 MB
125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdfMarch 1, 2022602 KB
125742_S1_M1_us-agent-authorization.pdfMarch 1, 20221 MB
125742_S1_M1_trans-of-oblig.pdfMarch 1, 2022717 KB
125742_S1_M1_ipsp-agreed-letter.pdfMarch 1, 2022658 KB
125742_S1_M1_financial-cert-bias.pdfMarch 1, 2022696 KB
125742_S1_M1_financial-cert-3454.pdfMarch 1, 20223 MB
125742_S1_M1_fast-track-designation.pdfMarch 1, 2022649 KB
125742_S1_M1_exclusivity-claim.pdfMarch 1, 2022616 KB
125742_S1_M1_debarment.pdfMarch 1, 2022656 KB
125742_S1_M1_cover.pdfMarch 1, 20221 MB
125742_S1_M1_3674.pdfMarch 1, 20225 MB
125742_S1_M1_356h.pdfMarch 1, 2022714 KB
125742_S1_M4_4223_R-20-0072.pdfMarch 1, 20225 MB
125742_S1_M4_4223_185350.pdfMarch 1, 20221 MB
125742_S1_M2_27_synopses-indiv-studies.pdfMarch 1, 20222 MB
125742_S1_M2_27_literature-references.pdfMarch 1, 20222 MB
125742_S1_M2_26_pharmkin-written-summary.pdfMarch 1, 20221 MB
125742_S1_M2_26_pharmkin-tabulated-summary.pdfMarch 1, 20221 MB
125742_S1_M2_24_nonclinical-overview.pdfMarch 1, 20222 MB
125742_S1_M2_22_introduction.pdfMarch 1, 2022670 KB
125742_S1_M1_waiver-req-designated-suffix.pdfMarch 1, 20223 MB
125742_S1_M1_userfee.pdfMarch 1, 2022628 KB
CRFs-for-site-1128.pdfJanuary 31, 202214 MB
CRFs-for-site-1096.pdfJanuary 18, 202211 MB
CRFs-for-site-1081.pdfDecember 30, 202113 MB
Supplemental-Index-12-22-21.pdfDecember 22, 20212 MB
STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdfDecember 13, 20216 MB
STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdfDecember 13, 20213 MB
STN-125742_0_0-Section-2.5-Clinical-Overview.pdfDecember 13, 20214 MB
signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdfDecember 13, 2021207 KB
CRFs-for-site-1055.pdfDecember 13, 20216 MB
BATES-FDA-CBER-2021-5683-0002379_te.xptDecember 13, 20213 KB
BATES-FDA-CBER-2021-5683-0002380_ti.xptDecember 13, 202137 KB
BATES-FDA-CBER-2021-5683-0002377_supppr.xptDecember 13, 202172 KB
BATES-FDA-CBER-2021-5683-0002378_ta.xptDecember 13, 20218 KB
BATES-FDA-CBER-2021-5683-0002376_relrec.xptDecember 13, 2021567 KB
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txtDecember 13, 20215 KB
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdfDecember 1, 202114 MB
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdfDecember 1, 202112 MB
BATES-93_tv.xptNovember 17, 202116 KB
5.2-tabular-listing.pdfNovember 17, 20212 MB
5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdfNovember 17, 20218 MB
BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txtNovember 17, 20219 KB
5.3.6-postmarketing-experience.pdfNovember 17, 2021984 KB
TitleDateFile SizeLink
034 – Transcript of Scheduling Conference (December 14, 2021).pdfMarch 17, 2022141 KB
Order-February-7-2022.pdfFebruary 7, 2022151 KB
056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdfFebruary 2, 2022124 KB
047-PLAINTIFFS-RESPONSE-TO-PFIZER-INC.S-MOTION-FOR-LEAVE-TO-INTERVENE-FOR-A-LIMITED-PURPOSE.pdfJanuary 25, 2022293 KB
046-RESPONSE-filed-by-Food-and-Drug-Administration-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdfJanuary 25, 2022128 KB
044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-THE-SCHEDULING-ORDER-OF-THE-COURT.pdfJanuary 24, 2022420 KB
041-Memorandum-in-Support-filed-by-Pfizer-Inc.-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdfJanuary 21, 20221,014 KB
038-Appendix-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order.pdfJanuary 18, 20221 MB
037-Brief-Memorandum-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order-1.pdfJanuary 18, 2022247 KB
ORDER_2022_01_06.pdfJanuary 6, 2022169 KB
032-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-31-Reply.pdfDecember 13, 202124 MB
031-REPLY-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-22-Brief-Memorandum-in-Support-of-Motion.pdfDecember 13, 2021175 KB
030-FDAs-Appendix-in-Support-of-Brief.pdfDecember 13, 20211 MB
029-FDAs-Reply-re-Brief-in-Support-of-Motion.pdfDecember 13, 2021280 KB
027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdfDecember 7, 202116 MB
026-Brief-Memorandum-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-21-Order-Setting-DeadlineHearing.pdfDecember 7, 2021239 KB
023-FDA-Appendix-in-Support-1.pdfDecember 6, 20219 MB
022-FDA-Brief-in-Advance-of-Scheduling-Conference.pdfDecember 6, 2021273 KB
111521-Second-Joint-Status-Report.pdfNovember 15, 2021382 KB
091621-Complaint.pdfSeptember 16, 20211 MB

Pfizer’s Documents – Full Productions

TitleDateFile SizeLink
pd production 060123 1.zipJune 1, 2023110 MB
pd production 060123 2.zipJune 1, 2023110 MB
pd production 060123 3.zipJune 1, 202397 MB
pd-production-050123-1.zipMay 1, 2023183 MB
pd-production-050123-2.zipMay 1, 2023165 MB
pd production 040323.zipApril 3, 2023196 MB
pd production 030123.zipMarch 1, 202345 MB
pd-production-020123.zipFebruary 1, 2023126 MB
pd-production-010323-1.zipJanuary 3, 2023124 MB
pd-production-010323-2.zipJanuary 3, 202330 MB
pd-production-120122.zipDecember 1, 202220 MB
pd-production-110122.zipNovember 1, 202271 MB
pd-production-100322.zipOctober 3, 202255 MB
pd-production-090122.zipSeptember 1, 202211 MB
pd-production-080122.zipAugust 1, 202248 MB
pd-production-070122.zipJuly 1, 2022199 MB
pd-production-060122.zipJune 1, 2022157 MB
pd-production-050222.zipMay 2, 2022396 MB
pd-production-040122.zipApril 1, 2022128 MB
pd-production-032422.zipMarch 24, 20222 MB
pd-production-030122.zipMarch 1, 2022195 MB
pd-production-013122.zipJanuary 31, 202214 MB
pd-production-011822.zipJanuary 18, 202211 MB
pd-production-123021.zipDecember 30, 202113 MB
pd-production-122221.zipDecember 22, 20212 MB
pd-production-121321.zipDecember 13, 202121 MB
pd-production-120121.zipDecember 1, 202126 MB
pd-production-111721.zipNovember 17, 202111 MB

Court Documents – Full Productions

TitleDateFile SizeLink
cd-production-031622.zipMarch 17, 2022101 KB
cd-production-020722.zipFebruary 7, 2022151 KB
cd-production-020222.zipFebruary 2, 2022125 KB
cd-production-012522.zipJanuary 25, 2022422 KB
cd-production-012422.zipJanuary 24, 2022420 KB
cd-production-012122.zipJanuary 21, 20221,014 KB
cd-production-011822.zipJanuary 18, 20221 MB
cd-production-010622.zipJanuary 6, 2022170 KB
cd-production-121321.zipDecember 13, 202126 MB
cd-production-120721.zipDecember 7, 202117 MB
cd-production-120621.zipDecember 6, 20219 MB
cd-production-111521.zipNovember 15, 2021382 KB
cd-production-091621.zipSeptember 16, 20211 MB