The court-ordered FDA release of Pfizer's COVID-19 vaccine BLA submission (~450K pages across 4 sub-collections), mirrored from PHMPT.org. Searchable with AI explain.
Get an AI answer drawn only from the Pfizer Documents (PHMPT/FDA) documents indexed here — every claim cited back to the filing or proceeding it came from. It will tell you plainly when the record doesn't cover your question, rather than guessing.
Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -4.1-1: Lis ting of subjects´ incl usion in analysis sets - BNT 162b1 Safety set Dose g roup Subj ect number Safety set (SAF) Safety boost set (SAFB) Immu nogenicity set (IMM) Prime + 7 Days com pleters set (CP7) Prime to…
Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fina l 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of col lection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r…
BioNTech RNA Pharmaceuticals GmbH Confidential Interim Clinical Study Report BNT162 -01 Page 1 of 1 Version: NA Date: 02 Sep 2020 16.1.4.1 List of investigators Site number Investigator Site type Site address Site status Deputy investigator (s) at the site 276-01 (Coordinating investigato r & Principal investigator Mannheim) Dr. Dr. med. Armin Schultz Clinical CRO site CRS Clinical Research Services Mann heim GmbH Grenadier Str. 1 68167 Mannheim …
090177e1969715a8\Approved\Approved On: 23-Mar-2021 06:33 (GMT) FDA-CBER-2021-5683-0049331
BioNTech RNA Pharmaceuticals GmbH Confidential Interim Clinical Study Report BNT162 -01 Page 1 of 1 Version: 1.0 Date: 12 Sep 2020 16.1.3 List of independent ethics committees Site number IEC including address and country, registration number, contact details Chairperson 276-01 Medical Board Baden -Württemberg, Ethical Commission Liebknechtstr. 33 70565 Stuttgart Germany Phone: ++49 -711-76989 -0 Fax: ++49 -711-76989 -856 Internet: www.aertzekammer@laek…
Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -4.2-1: Lis ting of subjects excluded from Safety boost set - BNT 162b1 Safety set Dose g roup Subj ect num ber Reaso n for exclusion Date of f irst info rmed consent Date o f scre ening 10 µg You nger 10010 Subj ect did not receive…
Site:CRSMannheim Group:PartA SubjectIdentifier: 276-01-0075 Status:Allocated 1 090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT) FDA-CBER-2021-5683-0057449 Row oo sNo do e Reaso o do e Da e e Hea Ra e (bea s/ )I e p e a o C ca S g f ca ce F d gs, select all that apply 1 [ ]11/05/202 0 11 May 202009:22 65 [x] No a [ ] Ab o a [ ] NCS [ ] CS Please insert new row(s), if you are in visit "Unscheduled Forms" only! Subject Identifier: 276-01-0075 Site: CRS…
Site:CRS Mannheim Group:Part A Subject Identifier: 276-01-0010 Status:Discontinued 1 090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT) FDA-CBER-2021-5683-0057374 Row oo sNo do e Reaso o do e Da e e Hea Ra e (bea s/ )I e p e a o C ca S g f ca ce F d gs, select all that apply 1 [ ]22/04/202 0 22 Ap 202009:35 59 [x] No a [ ] Ab o a [ ] NCS [ ] CS Please insert new row(s), if you are in visit "Unscheduled Forms" only! Subject Identifier: 276-01-0010 Site:…
Site:CRS Berlin Group:Part A Subject Identifier: 276-02-0215 Status:Allocated 1 090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT) FDA-CBER-2021-5683-0057543 Row oo sNo do e Reaso o do e Da e e Hea Ra e (bea s/ )I e p e a o C ca S g f ca ce F d gs, select all that apply 1 [ ]11/08/202 0 11 Aug 202009:33 59 [ ] No a [x] Ab o a [x] NCS [ ] CS 109 Please insert new row(s), if you are in visit "Unscheduled Forms" only! Subject Identifier: 276-02-0215 Site:…
Site: CRS Berlin Group: Part A Subject Identifier: 276-02-0242 Status: Allocated 1 090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT) FDA-CBER-2021-5683-0057721 Row oo sNo do e Reaso o do e Da e e Hea Ra e (bea s/ )I e p e a o C ca S g f ca ce F d gs, select all that apply 1 [ ]28/08/202 0 28 Aug 202009:30 88 [x] No a [ ] Ab o a [ ] NCS [ ] CS Please insert new row(s), if you are in visit "Unscheduled Forms" only! Subject Identifier: 276-02-0242 Site:…
May 13, 2022 Please Note, A review of PRB records indicates that there are no pending lots or issues that would affect the approval of the stated STN. 125742/45 Biologist, Product Release Branch CBER/OCBQ/DMPQWO, Building 71, Room 6062 240-402-9165 (main)/ 240-402-5839 (office) [email protected] Lot Release Information _________________________________________________ From: Gottschalk, Laura <[email protected]> Sent: Wednesday, May 11, 2022 7:52 PM To:CBER Lot Clearance…
From: Gottschalk, Laura Sent: Wednesday, May 11, 2022 7:52 PM To: CBER Lot Clearance <cbe [email protected]> Cc: Naik, Ramachandra <[email protected]>; MaguireThon, Meghan <[email protected]>; Smith, Michael (CBER) <[email protected]> Subject: OVRR: Lot Clearance Request for STN 125742/45 Please confirm that there are no pending lot release issues that would prevent approval of this efficacy supplement. x Applicant Name: BioNTech…
www.fda.gov___________________________________________________________________________ Memorandum DATE: May 11, 2022 TO: Ramachandra Naik, OMPT/CBER/OVRR/DVRPA Laura Gottschalk, OMPT/CBER/OVRR/DVRPA Michael Smith, OMPT/CBER/OVRR/DVRPASusan Wollersheim, Medical Officer, OMPT/CBER/OVRR/DVRPA FROM : Oluchi Elekwachi, Regulatory Reviewer OCBQ/DCM/APLB THROUGH: Lisa Stockbridge, Branch Chief OCBQ/DCM/APLB SUBJECT: COMIRNATY (COVID-19 vaccine, mRNA) Suspension for intramuscular injectionBLA…
From: Smith, Michael (CBER) Sent: Tuesday, May 10, 2022 11:53 AM To:'Collins, Kathleen Mary Catherine' Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; 'MaguireThon, Meghan' <[email protected]>; 'Mineo, Gosia' ; 'Harkins Tull, Elisa' <Elisa. [email protected]>; 'Devlin, Carmel M' <[email protected]>Subject: STN 125742/45: Revised PI labeling Kate, We have reviewed the Package Insert that was submitted to STN…
Department of Health and Human Services Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Pharmacovigilance (OBPV) Division of Pharmacovigilance (DPV) PHARMACOVIGILANCE PLAN REVIEW MEMORANDUM From: Deborah L. Thompson, MD, MSPH Medical Officer, Pharmacovigilance Branch 3 (PB3) DPV, OBPV, CBER, FDA To: Ramachandra Naik, PhD Chair, Review Committee Office of Vaccines Research and Review (OVRR), CBER,…
1 MAY MONTHLY MEETING SUMMARY Application number: BLA STN 125742/45 Product name: COVID-19 Vaccine, mRNA (COMIRNATY) Proposed Indication: Active immunization to prevent coronavirus disease 19 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older Applicant: BioNTech Manufacturing GmbH Meeting date & time: May 6, 2022; 12:30 - 1:30 PM EST Committee Chair: Ramachandra Naik, Ph.D. Meeting Recorders: …
From: Smith, Michael (CBER) Sent: Wednesday, May 4, 2022 10:25 AM To:Collins, Kathleen Mary Catherin e Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; MaguireThon, Meghan <[email protected]>; Mineo, Gosia ; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]>Subject: STN 125742/45: IR RE placebo recipient information contained in the PI Kate, The review team has the below…
CMC REVIEW MEMORANDUM Date: May 2, 2022 To: The Biologics License Application (BLA) File STN 125742 From: Xiao Wang, CMC Reviewer, OVRR/DVP Through: Anissa Cheung, OVRR/DVP Keith Peden, Lab Chief, OVRR/DVP Jerry Weir, Director, OVRR/DVP CC: Robin Levis, Deputy Director, OVRR/DVP Ramachandra Naik, Chair, OVRR/DVRPA Capt. Michael Smith, RPM, OVRR/DVRPA Laura Gottschalk, RPM, OVRR/DVRPA Applicant: BioNTech Manufacturing GmbH (in partnership with…
From: Mineo, Gosia Sent: Tuesday, April 26, 2022 4:14 PM To: Smith, Michael (CBER) <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; MaguireThon, Meghan <[email protected]>; Harkins Tull, Elisa <Elisa.HarkinsT [email protected]>; Devlin, Carmel M <[email protected]>; Collins, Kathleen Mary Catherin e Subject: RE: [EXTERNAL] RE: STN 125742/45 & IND 19736: IR RE request for a revised…
From: Smith, Michael (CBER) Sent: Friday, April 22, 2022 2:52 PM To:Collins, Kathleen Mary Catherine ; Mineo, Gosia Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; MaguireThon, Meghan <[email protected]>; Harkins Tull, Elisa <Elisa.Harkin [email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742/45 & IND 19736: IR RE request for a revised study protocol for Study C4591022 - pregnancy registry study…