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DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 August 23, 2021 Christopher Nagra BioNTech Manufacturing GmbH 7000 Portage RoadKalamazoo, Michigan 49001 Report on action taken on product submitted: Released COVID-19 Vaccine, mRNA Lot No(s).: FD7220 Sincerely, John A. Eltermann -SDigitally signed by John A. Eltermann -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300049305, cn=John A. Eltermann -S Date: 2021.08.23…
Pfizer Documents (PHMPT/FDA)
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FOIA FDA/CBER #2021 -5683 50,040 pages of Drug Master Files that are being Withheld in Full as exempt from disclosure pursuant to FOIA Exemption 4 Bates Numbers: FDA -CBER -2021 -5683 -1150835 -1200874
Pfizer Documents (PHMPT/FDA)
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Page 1of 12Reason for Submission ܈For Release
For Surveilla nce ܆For Licensing Action* STN: 125742_0
Corrected Protocol Date : 01-Oct-2021 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are reported and…
Pfizer Documents (PHMPT/FDA)
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Page 1of 12Reason for Submission ܈For Release
For Surveilla nce ܆For Licensing Action* STN: 125742_0
Corrected Protocol Date : 01-Oct-2021 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are reported and…
Pfizer Documents (PHMPT/FDA)
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Pfizer Documents (PHMPT/FDA)
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Page 1of 13Reason for Submission
For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0 ܈ Corrected Protocol Date : 19 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are…
Pfizer Documents (PHMPT/FDA)
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Page 1of 13Reason for Submission
For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0
Corrected Protocol Date : 18 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are…
Pfizer Documents (PHMPT/FDA)
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Page 1of 12Reason for Submission
For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0
Corrected Protocol Date : 18 Aug 2021 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are…
Pfizer Documents (PHMPT/FDA)
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Page 1of 13Reason for Submission
For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0
Corrected Protocol Date : 18 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are…
Pfizer Documents (PHMPT/FDA)
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Page 1of 12Reason for Submission
For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0 ܈ Corrected Protocol Date : 18 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are…
Pfizer Documents (PHMPT/FDA)
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Page 1of 12Reason for Submission
For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0
Corrected Protocol Date : 16 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are…
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Page 1of 13Reason for Submission ܆For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0 ܈ Corrected Protocol Date : 18 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are…
Pfizer Documents (PHMPT/FDA)
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Page 1of 13Reason for Submission ܆For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0
Corrected Protocol Date : 16 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are reported and…
Pfizer Documents (PHMPT/FDA)
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Page 1of 13Reason for Submission
For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0 ܈Corrected Protocol Date : 18 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are reported and…
Pfizer Documents (PHMPT/FDA)
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Page 1of 13Reason for Submission
For Release
For Surveilla nce ܈For Licensing Action* STN: 125742_0
Corrected Protocol Date : 16 Aug 21 Subject: Electronic Protocol Signature Page License No.: 2229 Company Name: Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH Pharmacia & Upjohn Company LLC for BioNTech Manufacturing GmbH hereby submits the following lot as an electronic submission by Electronic Submissions Gateway (ESG). All test conducted on this lot are…
Pfizer Documents (PHMPT/FDA)
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1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
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BNT162b2 3.2.S.2.4 Control of Critical Steps and Intermediates Manufacturing Process PFIZER CONFIDENTIAL Page 13.2.S.2.4. MANUFACTURING PROCES S 3.2.S.2.4.1. Introduction This section provides a description of the controls of critical process steps employ ed during manufacture of BNT162b2 drug substance to ensure that product quality is maintained. Process parameters and tests that are used to control the process and drug substance qualit y are provided in this section. Process parameters…
Pfizer Documents (PHMPT/FDA)
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Pfizer Andover Response to the FORM FDA 483 PAI BLA 125742 (COVID -19 mRNA Vaccine) This document contains Confidential Commercial and Trade Information not authorized for public disclosure . Page 1 of 36 Observation 1: There is insufficient data to support product quality prior to the release of BNT162b2 drug substance (DS) batch FA8057 manufactured at Pfizer Andover on was derived from batch , and a devi ation ( was initiated due to the multiple control limit…
Pfizer Documents (PHMPT/FDA)
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Pfizer Inc. 500 Arcola Road Collegeville, PA 1426 Global Product Developm ent 04December2020 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGISTRATION OF PRODUCTS FOR…
Pfizer Documents (PHMPT/FDA)
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Listing 7.7.3 Page 1of 13 BNT162b2 Protocol C4591008 Subjects Excluded from the Analyses PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL Generated from /dcri/ct/hero_together/lists/l_excluded.sas on 24MAY2021 12:45 Page 6of 1689 Subject ID Age/Sex/Race Exclusion Reason C4591008 -1021401152 41/F/AMERICAN INDIAN OR ALASKA Vaccinated more than 60 days prior to enrollment C4591008 -1044886080 54/M/WHITE Vaccinated more than 60 days prior to…