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COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions PFIZER CONFIDENTIAL Page 1QUERY 1 Please submit an updated manufacturing schedule for June 1 through October 31, 2021, that details upstream and downstream operations for BNT162b2 drug substance manufacturing in both and at Wy eth BioPharma Division of WyethPharmaceuticals LLC facility(FEI: 1222181) in Andover, MA in support of BLA 125742/0. RESPONSE 1…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 24May2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 20July2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
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Pharmaceutical Sciences Reference Standard CertificateW orldwide Research & Development ST ANDARD INFORMATION Compound Reference Standard Lot Reevaluation / Expiration Date Occupational Exposure Band OEB 505-AUG-2021PF-07302048-DP-RMPF-07302048 Long T erm Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 01-Feb-2021Rebekah WardPrimary Contact TESTS AND RESULTS Fluorescence assay mg/mL RNA Content FOOTNOTES Parent drug product lot C for up to days if sampled…
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BNT162b2 3.2.S.4.2 Analytical Procedures Overvie w PFIZER CONF IDEN TIAL Page 13.2.S.4.2. OVERVIEW Analy tical procedures for the control of BNT162b2 drug substance , are presented in this section ,as listed in Table 3.2.S.4.2-1 andTable 3.2.S.4.2-2. As requested b y FDA, the anal ytical standa rd operating procedures are presented in Section 3.2.R Standard Operating Procedure s, Method Validation and Transfer Repo rts. 090177e197030c1b\Approved\Approved On: 12-May-2021 06:05 (GMT) …
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______________________________________________________________________ _________________________________________________________________ _____ Summary Basis for Regulatory Action Date: 11/8/2021 From: Ramachandra Naik, PhD, Review Committee Chair , DVRPA/OVRR BLA STN: 125742/0 Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer , Inc.) Submission Receipt Date: May 18, 2021 PDUFA Action Due Date: January 1 6, 2022 Proper Name: COVID -19 Vaccine, mRNA Proprietary Name…
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Individuals using assistive technology may not be able to fully access the information contained in this file. For assistance, please call 800- 835-4709 or 240 -402-8010, extension 1. CBER Consumer Affairs Branch or send an e- mail to: [email protected] and include 508 Accommodation and the title of the document in the subject line of your e-mail. BLA 125742 Toxicology Review of COVID -19 Vaccine (BNT162, PF -07302048) (Final Report) From: Nabil, Al Humadi Through: Martin…
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Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research MEMO RANDUM Date: September 13, 2021 To: Ramachandra Naik From: Hong Yang, Ph.D., Patrick Funk, Ph.D. , and Osman N. Yogurtcu , Ph.D. Analytics and Benefit -Risk Assessment Team OBE Through: Richard Forshee, Ph.D. Acting Deputy Office Director OBE Re: STN 125742/0: review memo for benefit -risk assessment Page 2 – Hong Yang – 125742/0 …
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STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo 4/14/2022 1 BLA 125 742/0 COMIRNATY : Documentation Review Memo Product Information: COMIRNATY Indication and Use: Active immunization to prevent coronavirus disease 2019 ( COVID -19) caused by severe acute respiratory syndrome coronavirus 2 ( SARS -CoV-2) in individuals 16 years of age and older. Communications (IRs) from CBER: IR # Request Date CBER Rep(s) Request CBER …
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Clinical Reviewers: Susan Wollersheim, MD and Ann Schwartz, MD STN:125742 i BLA Clinical Review Memorandum * Application Type Biologics Licen se Application (BLA) STN 125742 /0 CBER Received Date May 18, 2021 PDUFA Goal Date January 16, 2022 Division / Office DVRPA / OVRR Priority Review (Yes/No) Yes Reviewer Name(s) Susan Wollersheim, MD Ann Schwartz, MD Review Completion Date / Stamped Date August 23, 2021 Supervisory Concurrence Lucia…
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BNT162b2 3.2.P.3.2 Batch Formula PFIZER CONFIDENTIAL Page 13.2.P.3.2. BATCH FORMULA The target drug product batch size Table 3.2.P.3.2 -1presents the unit formula for one liter of formulated bulk drug product soluti on, as well as batch formula s for representative batch size s of Table 3.2.P.3.2 -1. Batch Formula for BNT162b2 Bulk Drug Product Nam e of Ingredients Reference to StandardUnit Formula per 1 L (g) BNT162b2 d rug substance In-house specification0.5 ALC -0315 In-house …
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CBER Sentinel Program Sufficiency Memo: BNT162b2 (COVID- 19 Vaccine) /STN 125742 Last Updated on January 29 , 2019 1 De partment of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research CBER S ENTINEL PROGRAM SUFFICIENCY MEMORANDUM From: Joyce Obidi Health Scientist, CBER Surve illance Program Office of…
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BLA 125742 Toxicology Review of COVID -19 Vaccine (BNT162, PF -07302048) (Final Report) From: Nabil, Al Humadi Through: Martin Green To: Kirk Prutzman, Ramachandra Naik, Michael Smith File: BLA 125742, original submission Product: COVID-19 Vaccine (BNT162, PF -07302048) Reviewer: Nabil Al-Humadi BLA sections reviewed: 4.2.3.2 Repeated dose toxicity studies 4.2.3.5. Reproductive and Developmental Toxicity Type and date of…
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Summary Basis for Regulatory Action Date: 08/23/2021 From: Ramachandra Naik, PhD, Review Committee Chair , DVRPA/OVRR BLA STN: 125742/0 Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer , Inc.) Submission Receipt Date: May 18, 2021 PDUFA Action Due Date: January 1 6, 2022 Proper Name: COVID -19 Vaccine, mRNA Proprietary Name : COMIRNATY Indication: Active immunization to prevent coronavirus disease 2019 (COVID -19) caused by severe acute…
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U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 2099 3 w ww.fda.gov Our STN: BL 125742/0 BLA APPROVAL BioNTech Manufacturing GmbH August 23, 2021 Attention: Amit Patel Pfizer Inc. 235 East 42nd Street New York, NY 10017 Dear M r. Patel : Please refer to your Biologics License Application (BLA) submitted and received on May 18, 2021, under section 351(a) of the Publ ic Health Service Act (PHS Act) for COVID- 19…
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From: Gottschalk, Laura Sent: Sunday, August 22, 2021 10:28 AM To: Harkins Tull, Elisa <[email protected]> Cc: Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject: STN 125742/0 - Final Draft Label: Package Inse rt Dear Ms. Harkins, We have reviewed your draft Package Insert (PI) label submitted in Amendment 74…
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1 EMPLOYEE/OFFICER LIST MEMO To: The File Date: August 22, 2021 BLA: STN 1257 42/0 Sponsor: BioNTech Manufacturing G mbH Product: COVID- 19 Vaccine, mRNA (COMIRNATY) From: Laura Gottschalk , PhD (RPM) Through: Ramachandra Naik, PhD (Chair) The following officers or employees of FDA participated in the decision to approve this application and consented to be identified on this list. • Maria Allende, MD • Esmeralda Alvarado, PhD • Dennis Cato •…
Pfizer Documents (PHMPT/FDA)
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CBER CMC BLA Review Memo, STN 125742, COVID -19 mRNA Vaccine (nucleoside modified) CBE R CMC BLA Review Memorandum BL A STN 125742 CO VID-19 mRNA Vaccine (nucleoside modified) [ COMIRNATYTM] CDR Do nald Ertel, Regulatory Officer , OCBQ/DMPQ/MR B1 Laura Fontan, Consumer Safety Officer , OCBQ/DMPQ/MR B1 Alifiya Ghadiali, C onsumer Safety Officer , OCBQ/DMPQ/MRBII Kathleen R. Jones, Biologist , OCBQ/DMPQ/MR B1 Nicole Li, Microbiologist , OCBQ/DMPQ/ MRB1 Gregory Price, Biologist ,…
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1 Depar tment of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Epidemiology (OBE) REAL WORLD EVIDENCE BLA MEMORANDUM From : Yun Lu, PhD Mathematical Statistician Analytic s and Benefit -Risk Assessment Team ( ABRA) Office of Biostatistics and Epidemiology (OBE) CBER, FDA To: Ramachandra Naik, PhD Chair of the Review Committee …
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