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_5314_vr mvr 10080 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10080.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10214 att 03.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10214 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10214 att 02.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10214.pdfApril 3, 20233 MB
125742_S1_M5_5314_vr mqr 10212 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10212.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10211.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mqr 10211 att 01.pdfApril 3, 20232 MB
125742_S14_M1_cover.pdfApril 3, 20232 MB
125742_S7_M5_5351_bnt162 01 interim3 reports.pdfApril 3, 202325 MB
125742_S4_M1_response 18 may 2021 datasets.pdfApril 3, 2023714 KB
125742_S3_M1_proprietary name.pdfApril 3, 20232 MB
125742_S4_M1_cover.pdfApril 3, 2023675 KB
125742_S2_M5_5354_wi255886 protocol.pdfApril 3, 20231 MB
125742_S3_M1_cover.pdfApril 3, 2023705 KB
125742_S2_M5_5354_c4591022 protocol.pdfApril 3, 20233 MB
125742_S2_M5_5354_c4591014 protocol.pdfApril 3, 20233 MB
125742_S2_M5_5354_c4591012 protocol.pdfApril 3, 202315 MB
125742_S2_M5_5354_c4591011 protocol.pdfApril 3, 20235 MB
125742_S2_M5_5354_c4591009 protocol synopsis.pdfApril 3, 20232 MB
125742_S2_M5_5351_c4591015 protocol amend2.pdfApril 3, 202313 MB
125742_S2_M5_5354_c4591008 protocol.pdfApril 3, 20232 MB
125742_S2_M5_5351_c4591007 protocol amend1.pdfApril 3, 202324 MB
125742_S2_M1_pllr waiver request pregnancy registry.pdfApril 3, 20232 MB
125742_S2_M1_pllr lit search summary.pdfApril 3, 20232 MB
125742_S2_M1_pllr waiver request drug utilization.pdfApril 3, 20232 MB
125742_S2_M1_pllr cumulative review.pdfApril 3, 20232 MB
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
125742_S2_M1_cover.pdfApril 3, 2023697 KB
125742_S2_M1_dca anaphylactic reaction.pdfApril 3, 2023724 KB
125742_S1_M5_5351_c4591001 interim mth6 synopsis.pdfApril 3, 20234 MB
125742_S1_M5_5351_c4591001 interim mth6 report body.pdfApril 3, 202318 MB
125742_S1_M5_5351_c4591001 fa interim synopsis.pdfApril 3, 20231 MB
125742_S1_M5_5351_c4591001 fa interim report body.pdfApril 3, 202329 MB
125742_S1_M5_5314_vr tm 10304.pdfApril 3, 20235 MB
125742_S1_M5_5314_vr tm 10298.pdfApril 3, 20233 MB
125742_S1_M5_5314_vr tm 10294.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr sop lc 11120.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr tm 10293.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10083 att04.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10083 att02.pdfApril 3, 20231 MB
125742_S1_M5_5314_vr mvr 10083 att03.pdfApril 3, 20231 MB
125742_S1_M5_5314_vr mvr 10083 att01.pdfApril 3, 20231 MB
125742_S1_M5_5314_vr mvr 10081 att 01.pdfApril 3, 20232 MB
125742_S1_M5_5314_vr mvr 10083.pdfApril 3, 2023998 KB
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
FDA CBER 2021 5683 0773671 0774872_125742_S1_M5_C4591001 A Supp D adsl.zipMarch 1, 20237 MB
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
FDA CBER 2021 5683 0771969_125742_S1_M4_20gr142 D_suppma.zipMarch 1, 20231 KB
FDA CBER 2021 5683 0771970_125742_S1_M4_38166 D_suppma.zipMarch 1, 20231 KB
FDA CBER 2021 5683 0771971 0772060_125742_S1_M4_38166 D_suppmi.zipMarch 1, 202319 KB
FDA CBER 2021 5683 0772061 0772067_125742_S1_M4_20gr142 D_suppmi.zipMarch 1, 20233 KB
FDA CBER 2021 5683 0777995 0779196_125742_S1_M5_C4591001 S Supp_dm.zipMarch 1, 20231 MB
FDA CBER 2021 5683 0779197 0779201_125742_S1_M5_bnt162 01 A D_adsl.zipMarch 1, 202326 KB
FDA CBER 2021 5683 0779202 0779206_125742_S1_M5_bnt162 01 S Supp D_suppdm.zipMarch 1, 20232 KB
FDA CBER 2021 5683 0770969 0770973_125742_S1_M4_20gr142 D_se.zipMarch 1, 20232 KB
FDA CBER 2021 5683 0770974 0771048_125742_S1_M4_20gr142 D_suppbg.zipMarch 1, 202312 KB
FDA CBER 2021 5683 0771049 0771094_125742_S1_M4_20gr142 D_suppbw.zipMarch 1, 20238 KB
FDA CBER 2021 5683 0771095 0771515_125742_S1_M4_20gr142 D_suppcl.zipMarch 1, 202364 KB
FDA CBER 2021 5683 0771516 0771519_125742_S1_M4_20gr142 D_suppds.zipMarch 1, 20232 KB
FDA CBER 2021 5683 0770914 0770952_125742_S1_M4_38166 D_relrec.zipMarch 1, 20235 KB
FDA CBER 2021 5683 0770953 0770954_125742_S1_M4_20gr142 D_relrec.zipMarch 1, 20231 KB
FDA CBER 2021 5683 0770955 0770968_125742_S1_M4_38166 D_se.zipMarch 1, 20233 KB
FDA CBER 2021 5683 0770591 0770668_125742_S1_M4_20gr142 D_mi.zipMarch 1, 202344 KB
FDA CBER 2021 5683 0770669 0770851_125742_S1_M4_38166 D_om.zipMarch 1, 2023120 KB
FDA CBER 2021 5683 0770852 0770911_125742_S1_M4_20gr142 D_om.zipMarch 1, 202348 KB
FDA CBER 2021 5683 0770912 0770913_125742_S1_M4_20gr142 D_pooldef.zipMarch 1, 20231 KB
FDA CBER 2021 5683 0769635 0769835_125742_S1_M4_20gr142 D_lb.zipMarch 1, 2023212 KB
FDA CBER 2021 5683 0769836 0770088_125742_S1_M4_38166 D_ma.zipMarch 1, 202368 KB
FDA CBER 2021 5683 0770089 0770195_125742_S1_M4_20gr142 D_ma.zipMarch 1, 202350 KB
FDA CBER 2021 5683 0770196 0770590_125742_S1_M4_38166 D_mi.zipMarch 1, 2023214 KB
FDA CBER 2021 5683 0769055 0769067_125742_S1_M4_20gr142 D_fw.zipMarch 1, 202313 KB
FDA CBER 2021 5683 0769068 0769634_125742_S1_M4_38166 D_lb.zipMarch 1, 2023696 KB
FDA CBER 2021 5683 0769020 0769021_125742_S1_M4_20gr142 D_ds.zipMarch 1, 20232 KB
FDA CBER 2021 5683 0769022 0769033_125742_S1_M4_38166 D_ex.zipMarch 1, 20237 KB
FDA CBER 2021 5683 0769034 0769039_125742_S1_M4_20gr142 D_ex.zipMarch 1, 20234 KB
FDA CBER 2021 5683 0769040 0769054_125742_S1_M4_38166 D_fw.zipMarch 1, 202313 KB
FDA CBER 2021 5683 0769005_125742_S1_M4_20gr142 D_co.zipMarch 1, 20232 KB
FDA CBER 2021 5683 0769006 0769011_125742_S1_M4_38166 D_dm.zipMarch 1, 20232 KB
FDA CBER 2021 5683 0769012 0769013_125742_S1_M4_20gr142 D_dm.zipMarch 1, 20233 KB
FDA CBER 2021 5683 0769014 0769019_125742_S1_M4_38166 D_ds.zipMarch 1, 20232 KB
FDA CBER 2021 5683 0768301 0768323_125742_S1_M4_20gr142 D_bw.zipMarch 1, 202320 KB
FDA CBER 2021 5683 0768324 0768792_125742_S1_M4_38166 D_cl.zipMarch 1, 2023129 KB
FDA CBER 2021 5683 0768793 0769002_125742_S1_M4_20gr142 D_cl.zipMarch 1, 2023151 KB
FDA CBER 2021 5683 0769003 0769004_125742_S1_M4_38166 D_co.zipMarch 1, 20231 KB
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
FDA CBER 2021 5683 0768227 0768244_125742_S1_M4_20gr142 D_bg.zipMarch 1, 202317 KB
FDA CBER 2021 5683 0768245 0768300_125742_S1_M4_38166 D_bw.zipMarch 1, 202342 KB
FDA CBER 2021 5683 0771560 0771968_125742_S1_M4_20gr142 D_supplb.zipMarch 1, 202353 KB
FDA CBER 2021 5683 0767981 0768062_125742_S1_M4_20gr142_define.zipMarch 1, 202321 KB
FDA CBER 2021 5683 0768063 0768092_125742_S1_M4_20gr142_define2 0 0.zipMarch 1, 202314 KB
FDA CBER 2021 5683 0768093 0768158_125742_S1_M4_38166_define.zipMarch 1, 202328 KB
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
FDA CBER 2021 5683 0763794 0764725 125742_S1_M5_c4591001 A Supp D adae supp.zipFebruary 1, 20236 MB
FDA CBER 2021 5683 0764726 125742_S1_M5_c4591001 S D di.zipFebruary 1, 20232 KB
FDA CBER 2021 5683 0710069 0763793 125742_S1_M5_c4591001 A D adc19ef.zipFebruary 1, 202333 MB
FDA CBER 2021 5683 0710059 0710068 125742_S1_M5_bnt162 01 S D co.zipFebruary 1, 202313 KB
125742_S1_M4_4.2.2.4 01049 20010.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.4 01049 20009.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.1 vr vtr 10671.pdfFebruary 1, 20235 MB
125742_S1_M4_4.2.2.4 01049 20008.pdfFebruary 1, 20231 MB
125742_S1_M4_4.2.2 072424.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.1 vr vtr 10741.pdfFebruary 1, 20233 MB
125742_S1_M4_4.2.1 r 20 0211.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.1 r 20 0112.pdfFebruary 1, 20235 MB
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
125742_S1_M2_2.6.7.1toxicology tabulated summary.pdfFebruary 1, 2023960 KB
125742_S1_M2_2.6.3.1 pharmacol tabulated summaryFebruary 1, 20232 MB
125742_S1_M2_2.6.2 pharmacol written summary.pdfFebruary 1, 20237 MB
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
125742_S1_M4_4.2.2.4 01049 20021.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.4 01049 20022.pdfFebruary 1, 20232 MB
125742_S1_M4_4.2.2.4 01049 20020.pdfFebruary 1, 20232 MB
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
125742_S70_M1_lab-1448-0-7-annotated.pdfJanuary 3, 20232 MB
125742_S70_M1_lab-1448-0-7-pkg-insert-clean.pdfJanuary 3, 20231 MB
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
125742_S73_M1_lab-1448-0-8-annotated.pdfJanuary 3, 20233 MB
125742_S73_M1_lab-1448-0-8-pkg-insert-clean.pdfJanuary 3, 20231 MB
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
125742_S76_M1_lab-1448-0-9-annotated.pdfJanuary 3, 20231 MB
125742_S76_M1_lab-1448-0-9-pkg-insert-clean.pdfJanuary 3, 20231 MB
98A_BLA_125742-0_08-19-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S76_M1_lab-1448-0-9-pkg-insert-track.pdfJanuary 3, 20231 MB
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
125742_S12_M1_waiver-req-preservative.pdfJanuary 3, 2023710 KB
125742_S13_M5_5351_c4591001-adae-hiv-listing.pdfJanuary 3, 2023683 KB
125742_S13_M5_5351_c4591001-narrative-1226-12262255January 3, 2023626 KB
125742_S16_M1_ped-studies-deferral-track-change.pdfJanuary 3, 2023664 KB
125742_S16_M1_psp-track.pdfJanuary 3, 2023922 KB
125742_S21_M1_pharmacovigilance-planJanuary 3, 202313 MB
125742_S21_M1_pvp-track.pdfJanuary 3, 20238 MB
FDA-CBER-2021-5683-0652443-0652471-125742_S33_M5_5351_c4591001-508-efficacy-tables.doc.zipJanuary 3, 202353 KB
FDA-CBER-2021-5683-0652472-0652503-125742_S38_M5_c4591001-508-safety-tables.doc.docxJanuary 3, 202373 KB
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
125742_S29_M1_lab-1448-0-2-annotated.pdfJanuary 3, 20233 MB
FDA-CBER-2021-5683-0652526-0652547-125742_S39_M1_lab-1448-0-3-annotated.doc.zipJanuary 3, 2023494 KB
FDA-CBER-2021-5683-0652548-0652569-125742_S39_M1_lab-1448-0-3-pkg-insert-clean.doc.zipJanuary 3, 2023458 KB
125742_S29_M1_lab-1448-0-2-pkg-insert-clean.pdfJanuary 3, 20231 MB
FDA-CBER-2021-5683-0652570-0652590-125742_S51_M1_lab-1448-0-4-pkg-insert-track.docxJanuary 3, 2023522 KB
FDA-CBER-2021-5683-0652591-0652611-125742_S51_M1_lab-1448-0-4-annotated.docxJanuary 3, 2023539 KB
125742_S29_M1_lab-1448-0-2-pkg-insert-trackJanuary 3, 20231 MB
FDA-CBER-2021-5683-0652612-0652632-125742_S51_M1_lab-1448-0-4-pkg-insert-clean.docxJanuary 3, 2023513 KB
125742_S33_M5_5351_c4591001-508-efficacy-tables.pdfJanuary 3, 2023821 KB
FDA-CBER-2021-5683-0652633-0652652-125742_S58_M1_lab-1448-0-5-annotated.docxJanuary 3, 2023523 KB
FDA-CBER-2021-5683-0652653-0652672-125742_S58_M1_lab-1448-0-5-pkg-insert-track.docxJanuary 3, 2023514 KB
125742_S38_M5_c4591001-508-safety-tables.pdfJanuary 3, 2023928 KB
FDA-CBER-2021-5683-0652673-0652692-125742_S58_M1_lab-1448-0-5-pkg-insert-clean.docxJanuary 3, 2023514 KB
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
125742_S39_M1_lab-1448-0-3-annotated.pdfJanuary 3, 20236 MB
FDA-CBER-2021-5683-0652714-0652734-125742_S68_M1_lab-1448-0-6-pkg-insert-clean.docxJanuary 3, 2023514 KB
FDA-CBER-2021-5683-0652735-0652755-125742_S68_M1_lab-1448-0-6-pkg-insert-track.docxJanuary 3, 2023515 KB
125742_S39_M1_lab-1448-0-3-pkg-insert-cleanJanuary 3, 20235 MB
FDA-CBER-2021-5683-0652756-0652776-125742_S70_M1_lab-1448-0-7-annotated.docxJanuary 3, 2023520 KB
FDA-CBER-2021-5683-0652777-0652797-125742_S70_M1_lab-1448-0-7-pkg-insert-clean.docxJanuary 3, 2023522 KB
125742_S39_M1_lab-1448-0-3-pkg-insert-track.pdfJanuary 3, 20235 MB
FDA-CBER-2021-5683-0652798-0652818-125742_S70_M1_lab-1448-0-7-pkg-insert-track.docxJanuary 3, 2023515 KB
FDA-CBER-2021-5683-0652819-0652838-125742_S73_M1_lab-1448-0-8-pkg-insert-clean.docxJanuary 3, 2023515 KB
125742_S41_M1_c4591001-ve-tables.pdfJanuary 3, 2023695 KB
FDA-CBER-2021-5683-0652839-0652858-125742_S73_M1_lab-1448-0-8-annotated.docxJanuary 3, 2023521 KB
FDA-CBER-2021-5683-0652859-0652878-125742_S73_M1_lab-1448-0-8-pkg-insert-track.docxJanuary 3, 2023516 KB
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
FDA-CBER-2021-5683-0652899-0652919-125742_S76_M1_lab-1448-0-9-pkg-insert-track.docxJanuary 3, 2023515 KB
125742_S46_M1_carton-com25ctpus-puurs.pdfJanuary 3, 2023241 KB
FDA-CBER-2021-5683-0652920-0652940-125742_S76_M1_lab-1448-0-9-annotated.docxJanuary 3, 2023519 KB
125742_S46_M1_carton-com195lkz-kzoo.pdfJanuary 3, 2023140 KB
FDA-CBER-2021-5683-0652941-0652960-125742_S79_M1_lab-1448-1-0-pkg-insert-clean.docxJanuary 3, 2023515 KB
FDA-CBER-2021-5683-0652961-0652980-125742_S80_M1_lab-1448-1-0-pkg-insert-clean.docxJanuary 3, 2023515 KB
125742_S46_M1_carton-com195lpus-puurs.pdfJanuary 3, 2023179 KB
FDA-CBER-2021-5683-0652981-0654506-125742_S1_M5_bnt162-01-A-D-adlb.xpt.zipJanuary 3, 20233 MB
125742_S46_M1_label-comvlabkz-kzoo.pdfJanuary 3, 202349 KB
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125742_S46_M1_sticker-comdilrm.pdfJanuary 3, 202356 KB
125742_S51_M1_lab-1448-0-4-annotatedJanuary 3, 20234 MB
125742_S51_M1_lab-1448-0-4-pkg-insert-clean.pdfJanuary 3, 20231 MB
FDA-CBER-2021-5683-0654507-0658059-125742_S1_M5_bnt162-01-S-Supp-D-suppface.xpt.zipJanuary 3, 2023612 KB
125742_S51_M1_lab-1448-0-4-pkg-insert-track.pdfJanuary 3, 20231 MB
FDA-CBER-2021-5683-0658060-0661613-125742_S1_M5_bnt162-01-S-D-face.xpt.xpt.zipJanuary 3, 20232 MB
125742_S51_M5_5351_c4591001-followup-table.pdfJanuary 3, 2023606 KB
FDA-CBER-2021-5683-0661614-0663134-125742_S1_M5_bnt162-01-S-D-lb.xpt.zipJanuary 3, 20231 MB
125742_S54_M1_carton-com25ctkz-kzoo.pdfJanuary 3, 2023218 KB
FDA-CBER-2021-5683-0663135-0671344-125742_S1_M5_c4591001-A-D-adsympt.xpt.zipJanuary 3, 20234 MB
125742_S54_M1_carton-com25ctpus-puurs.pdfJanuary 3, 2023691 KB
FDA-CBER-2021-5683-0671345-0674997-125742_S1_M5_c4591001-S-D-supplb.xpt.zipJanuary 3, 2023504 KB
FDA-CBER-2021-5683-0674998-0678267-125742_S1_M5_c4591001-S-Supp-D-suppmb.xpt.zipJanuary 3, 2023438 KB
FDA-CBER-2021-5683-0678268-0681345-125742_S1_M5_c4591001-A-D-adds.xpt.zipJanuary 3, 20237 MB
125742_S54_M1_carton-com195lkz-kzooJanuary 3, 2023135 KB
125742_S54_M1_carton-com195lpus-puurs.pdfJanuary 3, 2023179 KB
FDA-CBER-2021-5683-0681346-0688437-125742_S1_M5_c4591001-S-D-ds.xpt.zipJanuary 3, 20232 MB
125742_S58_M1_lab-1448-0-5-annotated.pdfJanuary 3, 20233 MB
FDA-CBER-2021-5683-0688438-0698919-125742_S1_M5_c4591001-S-D-vs.xpt.zipJanuary 3, 20237 MB
125742_S58_M1_lab-1448-0-5-pkg-insert-clean.pdfJanuary 3, 2023878 KB
FDA-CBER-2021-5683-0698920-0703842-125742_S1_M5_c4591001-S-D-suppae.xpt.zipJanuary 3, 2023825 KB
125742_S58_M1_lab-1448-0-5-pkg-insert-track.pdfJanuary 3, 2023879 KB
FDA-CBER-2021-5683-0703843-0708840-125742_S1_M5_c4591001-S-Supp-D-suppae.xpt.zipJanuary 3, 2023845 KB
125742_S64_M1_carton-com25ctkz-kzoo.pdfJanuary 3, 2023217 KB
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125742_S64_M1_sticker-comdilrm.pdfJanuary 3, 2023180 KB
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125742_S68_M1_lab-1448-0-6-pkg-insert-clean.pdfJanuary 3, 20231 MB
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FDA-CBER-2021-5683-0634075-0650113-125742_S1_M5_c4591001-S-D-suppexDecember 1, 20223 MB
FDA-CBER-2021-5683-0633945-0634074-125742_S1_M5_bnt162-01-S-D-advaDecember 1, 2022169 KB
FDA-CBER-2021-5683-0633790-0633944-125742_S1_M5_bnt162-01-S-D-adcevdDecember 1, 2022133 KB
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FDA-CBER-2021-5683-0600620-0616658-125742_S1_M5_c4591001-S-D-suppecDecember 1, 20223 MB
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125742_S1_M4_20256434.pdf.zipNovember 1, 202220 MB
FDA-CBER-2021-5683-0539816-0593326-125742_S1_M5_c4591001-01-S-Supp-D-face.xpt.zipNovember 1, 202242 MB
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FDA-CBER-2021-5683-0308157 to -0396186_125742_S1_M5_c4591001-S-D-suppface.xptAugust 1, 2022467 MB
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125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdfJuly 1, 20225 MB
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125742_S1_M5_5351_c4591001 interim mth6 adverse events.zip (pdf)July 1, 202228 MB
FDA CBER 2021 5683 0208521 to 0216666_125742_S1_M5_c4591001 S Supp D suppvs.zip (xpt)June 1, 2022917 KB
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125742_S1_M5_5351_c4591001 interim mth6 patient batches.pdfJune 1, 20221 MB
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125742_S1_M5_5351_bnt162 01 interim3 lab measurements.pdfMay 2, 202291 MB
125742_S1_M5_5351_bnt162 01 interim3 report body.pdfMay 2, 202242 MB
125742_S1_M5_5351_bnt162 01 interim3 protocol deviations.pdfMay 2, 20221 MB
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125742_S1_M5_5351_bnt162 01 interim3 patient batches.pdfMay 2, 20223 MB
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125742_S1_M5_5351_c4591001 interim mth6 sponsor signature.pdfMay 2, 202212 MB
125742_S1_M5_5351_c4591001 interim mth6 sample crf.pdfMay 2, 20225 MB
125742_S1_M5_5351_c4591001 interim mth6 randomization sensitive.pdfMay 2, 202265 MB
125742_S1_M5_5351_bnt162 01 interim3 synopsis.pdfMay 2, 20224 MB
125742_S1_M5_5351_bnt162 01 interim3 sponsor signature.pdfMay 2, 20222 MB
125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdfMay 2, 20222 MB
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125742_S1_M5_5351_bnt162 01 interim3 sample crf.pdfMay 2, 20229 MB
125742_S1_M5_c4591001 S Supp acrf.pdfMay 2, 20223 MB
125742_S1_M5_c4591001 S csdrg.pdfMay 2, 20221 MB
125742_S1_M5_c4591001 S acrf.pdfMay 2, 20223 MB
125742_S1_M5_bnt162 01 S csdrg.pdfMay 2, 20221 MB
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FDA CBER 2021 5683 0058955 to 0058999_125742_S1_M5_bnt162 01 S define 2 0 0.xslMay 2, 2022183 KB
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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
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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
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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
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FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsxMarch 1, 202211 KB
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FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsxMarch 1, 202221 KB
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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
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FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txtMarch 1, 202249 KB
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FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txtMarch 1, 202212 KB
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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 040323.zipApril 3, 2023196 MB
pd production 030123.zipMarch 1, 202345 MB
pd-production-020123.zipFebruary 1, 2023126 MB
pd-production-010323-2.zipJanuary 3, 202330 MB
pd-production-010323-1.zipJanuary 3, 2023124 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