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
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
125742_S46_M1_label-comvlabp-puurs.pdfJanuary 3, 202355 KB
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
125742_S64_M1_carton-com25ctpus-puursJanuary 3, 2023242 KB
125742_S64_M1_carton-com195lkz-kzoo.pdfJanuary 3, 2023135 KB
125742_S64_M1_carton-com195lpus-puursJanuary 3, 2023178 KB
125742_S64_M1_label-comvlabkz-kzoo.pdfJanuary 3, 202349 KB
125742_S64_M1_label-comvlabp-puurs.pdfJanuary 3, 2023648 KB
125742_S64_M1_sticker-comdilrm.pdfJanuary 3, 2023180 KB
125742_S68_M1_lab-1448-0-6-annotated.pdfJanuary 3, 20233 MB
125742_S68_M1_lab-1448-0-6-pkg-insert-clean.pdfJanuary 3, 20231 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
FDA-CBER-2021-5683-0650114-0650115-125742_S1_M5_c4591001-S-D-tsDecember 1, 20224 KB
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
FDA-CBER-2021-5683-0623311-0633789-125742_S1_M5_c4591001-S-D-vsDecember 1, 20228 MB
FDA-CBER-2021-5683-0616659-0623310-125742_S1_M5_c4591001-S-D-svDecember 1, 20222 MB
FDA-CBER-2021-5683-0600620-0616658-125742_S1_M5_c4591001-S-D-suppecDecember 1, 20223 MB
FDA-CBER-2021-5683-0595944-0600619-125742_S1_M5_c4591001-S-D-seDecember 1, 20222 MB
FDA-CBER-2021-5683-0595465-0595943-125742_S1_M5_bnt162-01-S-D-vsDecember 1, 2022391 KB
FDA-CBER-2021-5683-0594977-0595464-125742_S1_M5_bnt162-01-S-D-suppvsDecember 1, 202286 KB
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
FDA-CBER-2021-5683-0593327-0593481-125742_S1_M5_bnt162-01-S-D-ce.xpt.zipNovember 1, 202271 KB
FDA-CBER-2021-5683-0593482-0593595-125742_S1_M5_bnt162-01-S-D-pe.xpt.zipNovember 1, 202242 KB
FDA-CBER-2021-5683-0593596-0593620-125742_S1_M5_bnt162-01-S-D-se.xpt.zipNovember 1, 202211 KB
FDA-CBER-2021-5683-0593621-0593664-125742_S1_M5_bnt162-01-S-Supp-D-suppae.xpt.zipNovember 1, 20226 KB
FDA-CBER-2021-5683-0593665-0593743-125742_S1_M5_bnt162-01-S-Supp-D-suppcm.xpt.zipNovember 1, 202219 KB
FDA-CBER-2021-5683-0593744-0593769-125742_S1_M5_bnt162-01-S-Supp-D-suppds.xpt.zipNovember 1, 20225 KB
FDA-CBER-2021-5683-0593770-0593800-125742_S1_M5_bnt162-01-S-Supp-D-suppec.xpt.zipNovember 1, 20227 KB
FDA-CBER-2021-5683-0593801-0593831-125742_S1_M5_bnt162-01-S-Supp-D-suppex.xpt.zipNovember 1, 20226 KB
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
FDA CBER 2021 5683 0537914 0539336 125742_S1_M5_bnt162 01 A D adfacevd.xptOctober 3, 202263 MB
FDA CBER 2021 5683 0484452 0484460 125742_S1_M5_bnt162 01 S D ti.xptOctober 3, 202284 KB
FDA CBER 2021 5683 0484419 0484441 125742_S1_M5_bnt162 01 S D eg.xptOctober 3, 2022300 KB
FDA CBER 2021 5683 0484442 0484451 125742_S1_M5_bnt162 01 S D ex.xptOctober 3, 202277 KB
FDA CBER 2021 5683 0484409 0484418 125742_S1_M5_bnt162 01 S D ec.xptOctober 3, 202281 KB
FDA CBER 2021 5683 0484384 0484408 125742_S1_M5_bnt162 01 S D ds.xptOctober 3, 2022171 KB
FDA CBER 2021 5683 0484379 0484383 125742_S1_M5_bnt162 01 S D dm.xptOctober 3, 202265 KB
FDA CBER 2021 5683 0484356 0484378 125742_S1_M5_bnt162 01 S D xa.xptOctober 3, 2022502 KB
FDA CBER 2021 5683 0484342 0484355 125742_S1_M5_bnt162 01 S D ae.xptOctober 3, 2022423 KB
FDA-CBER-2021-5683-0396255-0484341_125742_S1_M5_c4591001-S-Supp-D-suppface.xptSeptember 1, 2022467 MB
FDA CBER 2021 5683 0396247 0396248_125742_S1_M5_bnt162 01 S D ta.xptSeptember 1, 202218 KB
FDA CBER 2021 5683 0396249 0396254_125742_S1_M5_bnt162 01 S D xb.xptSeptember 1, 202243 KB
FDA CBER 2021 5683 0396239 0396241_125742_S1_M5_bnt162 01 S D suppeg.xptSeptember 1, 202213 KB
FDA CBER 2021 5683 0396242 0396246_125742_S1_M5_bnt162 01 S D suppxa.xptSeptember 1, 202224 KB
FDA CBER 2021 5683 0396223 0396227_125742_S1_M5_bnt162 01 S D dv.xptSeptember 1, 202267 KB
FDA CBER 2021 5683 0396228 0396233_125742_S1_M5_bnt162 01 S D rp.xptSeptember 1, 202262 KB
FDA CBER 2021 5683 0396234 0396238_125742_S1_M5_bnt162 01 S D suppdv.xptSeptember 1, 202256 KB
FDA CBER 2021 5683 0396214 0396222_125742_S1_M5_bnt162 01 S D cm.xptSeptember 1, 2022200 KB
FDA CBER 2021 5683 0396200 0396213_125742_S1_M5_bnt162 01 A D adae.xptSeptember 1, 2022804 KB
FDA-CBER-2021-5683-0396199_125742_S1_M5_bnt162-01-S-D-tv.zipAugust 1, 20221 KB
FDA CBER 2021 5683 0396197_125742_S1_M5_bnt162 01 S D supprp.xptAugust 1, 20223 KB
FDA CBER 2021 5683 0396198_125742_S1_M5_bnt162 01 S D te.xptAugust 1, 20227 KB
FDA CBER 2021 5683 0396193 to 0396194_125742_S1_M5_c4591001 S D supppe.xptAugust 1, 202212 KB
FDA CBER 2021 5683 0396195_125742_S1_M5_bnt162 01 S D relrec.xptAugust 1, 20222 KB
FDA CBER 2021 5683 0396196_125742_S1_M5_bnt162 01 S D supppe.xptAugust 1, 20226 KB
FDA CBER 2021 5683 0396187_125742_S1_M5_c4591001 S D pr.xptAugust 1, 202219 KB
FDA CBER 2021 5683 0396188 to 0396192_125742_S1_M5_c4591001 S D suppmo.xptAugust 1, 202265 KB
FDA CBER 2021 5683 0396199_125742_S1_M5_bnt162 01 S D tv.xptAugust 1, 20224 KB
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
FDA CBER 2021 5683 0285652 to 0286071_125742_S1_M5_c4591001 S D pe.zip (xpt)July 1, 2022170 KB
FDA CBER 2021 5683 0282366 to 0285643_125742_S1_M5_c4591001 S D mb.zip (xpt)July 1, 20222 MB
FDA CBER 2021 5683 0285644 to 0285651_125742_S1_M5_c4591001 S D mo.zip (xpt)July 1, 20226 KB
FDA CBER 2021 5683 0282329 to 0282365_125742_S1_M5_c4591001 S D ie.zip (xpt)July 1, 202219 KB
FDA CBER 2021 5683 0282130 to 0282328_125742_S1_M5_c4591001 S D cm.zip (xpt)July 1, 2022151 KB
FDA CBER 2021 5683 0225598 to 0282129_125742_S1_M5_c4591001 A Supp D adfacevd.zip (xpt)July 1, 202284 MB
FDA CBER 2021 5683 0225100 to 0225597_125742_S1_M5_c4591001 A D adcm.zip (xpt)July 1, 20221 MB
FDA CBER 2021 5683 0296904 to 0307543_125742_S1_M5_c4591001 S D suppce.zip (xpt)July 1, 20221 MB
FDA CBER 2021 5683 0286267 to 0296903_125742_S1_M5_c4591001 S Supp D suppce.zip (xpt)July 1, 20221 MB
FDA CBER 2021 5683 0286072 to 0286266_125742_S1_M5_c4591001 S Supp D relrec.zip (xpt)July 1, 202254 KB
125742_S1_M5_5351_c4591001 interim mth6 lab measurements sensitive.pdfJuly 1, 20225 MB
125742_S1_M5_5351_c4591001 interim mth6 interlab standard.pdfJuly 1, 202211 MB
125742_S1_M5_5351_c4591001 interim mth6 excluded patients sensitive.pdfJuly 1, 20223 MB
125742_S1_M5_5351_c4591001 interim mth6 excluded patients.pdfJuly 1, 20221 MB
125742_S1_M5_5351_c4591001 interim mth6 errata.pdfJuly 1, 20222 MB
125742_S1_M5_5351_c4591001 interim mth6 efficacy response.pdfJuly 1, 20221 MB
125742_S1_M5_5351_c4591001 interim mth6 discontinued patients.pdfJuly 1, 20224 MB
125742_S1_M5_5351_c4591001 interim mth6 compliance sensitive.pdfJuly 1, 20221 MB
125742_S2_M5_5354_wi235284 protocol.pdfJuly 1, 202215 MB
125742_S2_M1_right of reference.pdfJuly 1, 20222 MB
125742_S2_M1_loa dmf 031786 vials.pdfJuly 1, 20222 MB
125742_S2_M1_loa dmf 012683 vials.pdfJuly 1, 2022631 KB
125742_S2_M1_loa dmf 011820 vials.pdfJuly 1, 2022616 KB
125742_S2_M1_loa dmf 011793 vials.pdfJuly 1, 2022701 KB
125742_S2_M1_loa dmf 011321 vials.pdfJuly 1, 20221,019 KB
125742_S2_M1_loa dmf 10953 stopper.pdfJuly 1, 2022861 KB
125742_S2_M1_hospira diluent label.pdfJuly 1, 2022776 KB
125742_S2_M1_hospira diluent carton.pdfJuly 1, 2022987 KB
125742_S2_M1_fk diluent stamp.pdfJuly 1, 2022598 KB
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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-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