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.

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2373 documents

125742 S112 M1 cover

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 17September 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics Evaluation and Research Document Control 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…

125742 S111 M1 letter of authorization

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Page 1 of 2 BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz Germany Tel.: +49 (0) 6131 -90 84 0 Fax: +49 (0) 6131 -90 84 390 [email protected] Managing Director : Dr. Sierk Poetting Dr. Oliver Hennig Martin Lang Jan Kürschner Commercial Register District court Mainz HRB 47548 VAT: DE 313150544 Tax ref. no: DE263241058695198 Deutsche Bank IBAN: DE94 5507 0040 0070 1441 00 SWIFT: DEUTDE5MXXX Date: …

125742 S111 M1 cover

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 17September 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics Evaluation and Research Document Control 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…

125742 S59 M1 cover

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 18August202 1 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…

125742 S57 M3 32p3 manufacturer diluent

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 1 page

BNT162b2 3.2.P.3.1. Manufacturer(s) –[DILUENT] PFIZER CONFIDENTIAL Page 13.2.P.3.1. MANUFACTURER(S) Table 3.2.P.3.1-1 lists the sites that have responsibilities in the production of 0.9% sodium chloride, USP diluent and their specified functions. Table 3.2.P.3.1 -1.Sites and Responsibili ties for Diluent (0.9% Sodium Chloride, USP) Manufacture Site FEI / DUNS Numbers Responsibility Fresenius -Kabi USA, LLC Manufacture, testing and release (of 2 mL size diluent vials) Hospira, Inc…

125742 S57 M1 response 16aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742 .0 Response to 16Aug 2021 FDA IR–STN 125742.0 IR RE Diluent Suppliers PFIZER CONFIDENTIAL Page 1The review team has the below information request for y ou regarding y our diluent suppliers . QUERY 1 Due to the Warning Letter (reference WL 320 -20-31 issued 03/25/2020) and Official Action Indicated status of Pfizer Healthcare India Pvt. L td. (FEI# 3008316085), the Agency will not approve the diluent supplied from that manufacturer as part…

125742 S57 M1 cover

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 17August 2021 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…

125742 S56 M1 response 13aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 1 page

COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 13Aug 2021 FDA Commitment to Implement an Endotoxin Method on DP PFIZER CONFIDENTIAL Page 1As follow up from the teleconference with CBER on 16 August 2021 and recognizing CBER’s previous request of 06 August 2021 to: identify a for testing DP within the , and to provide a date b y which results from the test using samples can be included of DP lot release. Commitment to Implement Endotoxin Test Method Pfizer commits…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 17 August 2021 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…

125742 S55 M3 32p8 stability summary

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 30 pages

BNT162b2 3.2.P.8.1. Stability Summary and Conclusion PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 3.2.P.8.1. STABILITY SUMMARY AND CONCLUS ION ................................ .................... 4 3.2.P.8.1.1. Drug Product Shelf Life at Recommended Storage Temperature ................ 4 3.2.P.8.1.1.1. In-use Period of Drug Product…

125742 S55 M3 32p8 stability data long term

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 60 pages

BNT162b2 3.2.P.8.3 Stability Data Long Term PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES.....................................................................................................................1 LIST OF FIGURES ................................ ................................ ................................ ................... 3 3.2.P.8.3. STABILITY DATA - LONG TERM ................................ ................................ ........ 4 LIST OF TABLES Table…

125742 S55 M2 introduction

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BNT162b2 2.3Introduction to Quality Overall Summary –9 Month Expiry Extension PFIZER CONFIDENTIAL Page 12.3.INTRODUCTION TO THE QUALITY OVERA LL SUMMARY This document summarizes updates and changes to the Chemistry , Manufacturing and Controls (CMC) information for the COVID-19 vaccine for use under BLA 125742 . Specificall y, this CMC informational amendment covers the following changes. Introduction of additional stability data to support exten ding the shelf -life of the undiluted drug…

125742 S55 M2 drug product stability

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 28 pages

BNT162b2 2.3.P.8 Stability PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES.....................................................................................................................1 2.3.P.8. STABILITY ................................ ................................ ................................ .................. 3 2.3.P.8.1. Stability Summary and Conclusion ................................ ................................ ..3 2.3.P.8.1.1. Shelf L ife at Recommended…

125742 S55 M2 32p8 stability data accelerated

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 108 pages

BNT162b2 3.2.P.8.3. Stability Data Accelerated TABLE OF CONTENTS LIST OF TABLES.....................................................................................................................1 LIST OF FIGURES ................................ ................................ ................................ ................... 5 STABILITY DATA –ACC ELERATED ................................ ................................ .................. 7 LIST OF TABLES Table 3.2.P.8.3-1. Summary …

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 17 August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics 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 …

125742 S53 M1 response 13aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 20 pages

COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 13 Aug 2021FDA queries –Drug Substance (Pfizer Andover; PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES.....................................................................................................................1 QUERY 1 ................................ ................................ ................................ ................................ ...2 RESPONSE 1 ................................…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 17August2021 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 …

125742 S50 M3 32r comirnaty lot release template

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 12 pages

FDA-CBER-2021-5683-1149604 Page 2of 12cc: STN 125742 -0/2229/FC LotNum ber: Licen seNam eofProduct: [COVID -19 mRNA Vaccine (nucleoside modified)] Manufacturing Site :Pharmacia & Upjohn Company LLC, 7000 Portage Rd., Kalamazoo, MIC 49001 USA Date of Manufacture: Date of Expiry: Date of Fill: Product Inform ation : COMPONENTS Component DescriptionBatch NumberDate of Manuf.Manufacture Site QuantityTarget Concentration BNT162b2 Drug Substance LNP Fabrication N/A Bulk Drug Product Form…

125742 S50 M1 response 13aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 8 pages

COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 13Aug 2021 FDA queries –LRP Template IR PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS QUERY 1 ................................ ................................ ................................ ................................ ...2 RESPONSE 1 ................................ ................................ ................................ ................... 2 QUERY 2 ................................…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 16August 2021 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…