117 2 BLA 125742 0 08 22 2021 Inspection Related Inspect
(b) (4) (b) (4) FDA-CBER-2021-5683-1150343 FDA-CBER-2021-5683-1150344 FDA-CBER-2021-5683-1150345
Pfizer Documents (PHMPT/FDA)
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.
🧠 Ask this record
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.
116 BLA 125742 0 08 21 2021 Inspection Related Establi
Establishment Inspection Report FEI: 1222181 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. EI Start: 07/19 /2021 Andover, MA EI End: 07/23/2021 1 of 86 TABLE OF CONTENTS SUMMARY .............................................................................................................................. 1 ADMINISTRATIVE DATA ....................................................................................................... 2 PERSONS INTERVIEWED …
115 1 BLA 125742 0 08 21 2021 Telecon Labeling via FAX e
From: Gottschalk, Laura Sent: Saturday, August 21, 2021 11:11 AM To: Harkins Tull, Elisa <[email protected]> Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject: STN 125742/0 - Final Draft Labels: Carton and Containers Dear Ms. Harkins, We have reviewed your draft Carton and Container labels submitted in…
111 BLA 125742 0 08 21 2021 Telecon Advice
From: Naik, Ramachandra <[email protected]> Sent: Saturday, August 21, 2021 5:29 PM To: Harkins Tull, Elisa <[email protected]>; Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura <[email protected]> Cc: Boyce, Donna <[email protected]>; Devlin, Carmel M <[email protected]> Subject: RE: [E XTERNAL] BLA 125742/0 Status of any additional requests Dear Elisa, Thank you for sending/submitting responses to our…
110 1 Courtesy Copy BLA 125742 0 Analytical Method Review Memo COMIRNATY
DEPARTMENT OF HEALTH & HUMAN SERVICES Food & Drug Administrat ion Silver Spring, MD 20993 1 DBSQC/OCBQ ANALYTICAL METHOD REVIEW MEMO To: The file: STN 125742/0 From : Reviewer Date finalized Stamp Supervisor Stamp Emnet Yitbarek (Lead reviewer) 8/20/2021 Kori Francis Hsiaoling Wang 8/19/2021 Tao Pan Esmeralda Alvarado- Facundo 8/20/2021 Muhammad Shahabuddin Anil Choudhary 8/20/2021 Karla Garcia 8/20/2021 James Kenney …
109 Courtesy Copy 2 BLA 125742 0 CMC Review Memo August 21 2021 COMIRNATY
i CM C REVIEW M EMORANDUM Date: AUGUST 2 1, 2021 To: The Biologics License Application (BLA) File STN 125742 From: Xiao Wang, OVRR/ DVP, CMC Product Reviewer Through: Anissa Cheung, OVRR/DVP Keith Peden, Lab Chief, OVRR/DVP Robin Levis, Deputy Director, OVRR/DVP Jerry Weir, Director, OVRR/DVP CC: Ramachandra Naik, Chair, OVRR/DVRPA Capt. Michael Smith, RPM, OVRR/DVRPA Laura Gottschalk, RPM, OVRR/DVRPA Applicant : BioNTech Manufacturing GmbH (in partnership with Pfizer …
108 BLA 125742 0 08 21 2021 Inspection Related Inspect
To: F ile STN BL 125742/0 – COVID -19 mRNA Vaccine From : Christian D. Lynch, CSO, CBER/O D/BOS Through: Lori Peters , Branch Chief, CBER/OCBQ/DMPQ /MRBI John Eltermann, Director, CBER/DMPQ Mary A. Malarkey, Director, CBER/OCBQ CC: Ramachandra Naik , Ph.D., RPM , CBER/O VRR/DVRPA/CMC3 Michael Smith, Ph.D., RPM, CBER/OVRR/DVRPA/CMC3 Laura Gottschalk, Ph.D., RPM, CBER/OVRR/DVRPA/CMC3 Kat hleen R. Jones, Ph.D., Biologist, CBER/OCBQ/DMPQ/MRBI Ek aterina Allen,…
107A 1 BLA 125742 0 08 20 2021 Telecon Labeling via FAX e
From: Gottschalk, Laura < [email protected] > Sent: Wednesday, August 18, 2021 5:20 PM To: Harkins Tull, Elisa < [email protected] > Cc: Smith, Michael (CBER) < [email protected] >; Naik, Ramachandra <[email protected] >; Devlin, Carmel M <[email protected] >; Aghajani Memar, Neda < [email protected] > Subject: [EXTERNAL] STN 1 25742/0 – COMIRNATY (COVID -19 Vaccine, mRNA) - Comments regarding inclusion of draft carton…
107 1 BLA 125742 0 08 20 2021 Telecon Labeling via FAX e
From: Gottschalk, Laura Sent: Saturday, August 21, 2021 10:45 AM To: Harkins Tull, Elisa <[email protected]> Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject: RE: [EXTERNAL] RE: STN 125742/0: Comment regar ding vial labels Dear Elisa, We acknowledge that additional information regarding the diluent name…
105 BLA 125742 0 08 20 2021 Telecon Advice Information
From: Naik, Ramachandra Sent: Friday, August 20, 2021 2:08 PM To: Boyce, Donna < [email protected] > Cc: Malarkey, Mary < [email protected] >; Gruber, Marion < [email protected] >; Harkins Tull, Elisa < [email protected] >; Rohlfing, Paul < [email protected] >; Aghajani Memar, Neda <[email protected] >; Smith, Michael (CBER) <[email protected] >; Gottschalk, Laura < [email protected] > Subject: RE: Lot…
103 2 BLA 125742 0 08 20 2021 Memo Test Results
Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Silver Spring, MD 20993 STN 125742/0 Test Memo – H. Wang 1 To: STN 125742/0 From : Hsiaoling Wang , Ph.D., Analyst , CBER/ OCBQ/D BSQC/ LACBRP Through: Tao Pan, Ph.D., Team Lead, CBER/OCBQ/DBSQC/LACBRP Kori Francis, Acting Lab Chief , CBER/OCBQ/DBSQC/LACBRP Maryna Eichelberger, Ph.D., Division Director, CBER/OCBQ/DBSQC Mary A. Malarkey, Office Director , CBER/OCBQ Applicant: …
102 1 BLA 125742 0 08 20 2021 Memo Test Results
DEPARTMENT OF HEALTH AND HUMAN SERV ICES Food and Drug Administration Silver Spring MD 20993 MEMORANDUM FOR RECORD To STN # 125 742/0 August 20, 2021 From Hyesuk Kong, Ph. D. Karla Garcia, M.S. Seth Schult e, M.S. Laboratory of Microbiology, In -vivo Testing & Standards (LMIV TS) Division of Biological Standards and Quality Control (DBSQC) Office of Compliance and Biologics Quality…
101 Courtesy Copy BLA 125742 0 Pharmacovigilance Plan Review Addendum Memo COMIRNATY
1 Department of Health and Human Services Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Epidemiology (OBE) Division of Epidemiology (DE) PHARMACOVIGILANCE PLAN REVIEW: ADDENDUM MEMORANDUM From: Meghna Alimchandani, MD Deputy Director, Division of Epidemiology (DE) Kerry Welsh, MD Medical Officer, Analytic Epidemiology Branch (AEB) To: Ramachandra Naik, PhD Chair, Review…
100A BLA 125742 0 08 20 2021 Memo Other
Center for Biologics Evaluation and Research Laboratory Quality System COMIRNATY (BioNTech Manufacturing GmbH) COVID -19 mRNA Vaccine Document ID: 1 25742 Revision Level: 01 Revision Date: Effective Date: Total Pages: 5 (including this cover page) Document Uncontrolled if Printed Author Approval: _______________ - 1 - WARNING: The information contained in this document is CONFIDENTIAL and should not be released. See FOIA exemption regarding…
100 BLA 125742 0 08 20 2021 Memo Other
Center for Biologics Evaluation and Research Laboratory Quality System COMIRNATY (BioNTech Manufacturing GmbH) COVID -19 mRNA Vaccine Document ID: 1 25742 Revision Level: 01 Revision Date: Aug ust 20, 2021 Effective Date: August 20, 2021 Total Pages: 5 (including this cover page) - 1 - WARNING: The information contained in this document is CONFIDENTIAL and should not be released. See FOIA exemption regarding circumvention. Product Testing Plans document…
99 BLA 125742 0 08 20 2021 Memo Committee Memo Labeli
1 Date: August 20, 2021 From: Daphne D. Stewart, CSO Regulatory Management Support Branch, DVRPA/OVRR Through: Tim D. Nelle, Ph.D. , CAPT U.S. Public Health Service, Branch Chief, RMSB To: BLA STN 125742/0 File Subject Review of BioNTech Manufacturing GmbH – BLS 125742/0 COVID- 19 mRNA Vaccine (nucleoside modified) – COMIRNATY ® Carton and Container Labeling Background This Biologic License Application (BLA) is for COVID- 19 mRNA Vaccine (nucleoside modified)…
95 BLA 125742 0 08 19 2021 Memo Compliance Check Acce
From: DeCiero, Daniel Sent: Thursday, August 19, 2021 12:48 PM To: Zubkova, Iryna Cc: Peters, Lori; Naik, Ramachandra; Smith, Michael (CBER); Gottschalk, Laura; Ertel, Donald; Sausville, Robert; Anderson, Maria (CBER); Mendoza, Melissa; Malarkey, Mary Subject: RE: Request for Compliance Check BLA STN 125742/0 • Applicant Name: BioNTech Manufacturing GmbH • Product Names: 125742/0 - COVID -19 mRNA Vaccine (COMIRNATY) • License Number: 2229 • Address: BioNTech…
94 Courtesy Copy 1 BLA 125742 0 Statistical Review COMIRNATY
Statistical Review STN: 125742/0 Page i Application Type BLA, Original Application STN 125742/0 CBER Received Date May 18, 2021 PDUFA Goal Date January 16, 2022 Division / Office DVRPA /OVRR Committee Chair Ramachandra Naik Clinical Reviewer(s) Ann Schwartz; Susan Wollersheim Project Manager Michael Smith; Laura Gottschalk Priority Review Yes Reviewer Name Ye Yang , Mathematical Statistician, DB/VEB Review Completion Date / Stamped Date Concurrence …
93 Courtesy Copy 2 BLA 125742 0 Statistical Review COMIRNATY
Stati stical Review STN: 125742/0 Page i Application Type BLA, Original Application STN 125742/0 CBER Received Date May 18, 2021 PDUFA Goal Date January 16, 2022 Division / Office DVRPA /OVRR Committee Chair Ramachandra Naik Clinical Reviewer(s) Ann Schwartz; Susan Wollersheim Project Mana ger Mike Smith ; Laura Gottsch alk Priority Review Yes Reviewer Name(s) Lei Huang Review Completion Date / Stamped Date Supervisory Concur rence Tsai-Lien Lin, Bra…
92 BLA 125742 0 08 19 2021 Inspection Related Inspect
Establishment Inspection Report FEI: 1000654629 Pfizer Manufacturing Belgium NV EI Start: 06/24/2021 Puurs, Belgium EI End: 07/02/2021 1 of 79 TABLE OF CONTENTS Summary ............................................................................................................................... 1 Administrative Data ............................................................................................................... 2 Persons Interv iewed …