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 S35 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 06 Aug 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 S48 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 13August 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 S47 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 0.9% Sodium Chloride, USP Diluent Manufacture Site FEI / DUNS Numbers Responsibility Fresenius -Kabi USA LLC Manufacture, testing and release (of 2 mL size diluent vials) Hospira, Inc Manufacture,…

125742 S34 M1 response 03aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 14 pages

COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 03 August 2021 FDA queries PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES.....................................................................................................................1 QUERY 1 ................................ ................................ ................................ ................................ ...2 RESPONSE 1 ................................ ................................…

125742 S34 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 06 August 202 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 …

125742 S30 M1 response 26jul2021

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

COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Follow-up Response to 26 Jul 2021 FDA Query #10 PFIZER CONFIDENTIAL Page 1Reference is made to Query Response #10from FDA Information Request received 26 July 2021 received via email from Laura Gottschalk, OhD (CBER/OVRR): “Please clarify if any drug substance direct product contact items (e.g., single- use system, tubing, gaskets, small parts) used in either are autoclave sterilized. I f so, please provide the autoclave load…

125742 S30 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 03 August202 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 S26 M1 fda bnt cl

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

FDA-CBER-2021-5683-1149478 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-1149479

125742 S26 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 02August202 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 S26 M1 andover 483 response

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 36 pages

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 manufactured at Pfizer Andover on was derived from batch , and a devi ation ( ) was initiated due to the multiple control limit excursions…

125742 S25 M1 response 26jul2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 32 pages

COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 QUERY 1 ................................ ................................ ................................ ................................ ...3 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 30July202 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 S22 M1 response 16jul2021

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

COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 16Jul 2021FDA queries –Sterility and Endotoxin PFIZER CONFIDENTIAL Page 1QUERY 1 Regarding the sterility method: a. Please confirm that both PGS -Puurs and PGS- KZOtesting facilities will conduct of sterility tests since test results for were not optimal during the validation study . b. Please confirm that both PGS -Puurs and PGS-KZO testing facilities will conduct visu al inspection for growth during the . …

125742 S111 M1 356h

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 7 pages

09/17/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Amit Patel, Director, Pfizer Global Regulatory Affairs - Vaccines 235 East 42nd Street New York NY 10017214-918-5262 845-474-3500 [email protected] 125742 0010 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19…

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

FDA-CBER-2021-5683-1150806 Marion Gru ber, Ph.D., Director Page2of 2 BLA125742 24August2021 Pfizer Confid ential Page 2Sincerely, Amit Patel Director Global Regulatory Affairs -Vaccines CC: Ramachandra S. Naik, Ph.D. CC: Laura Gottschalk, Ph.D. CC: Captain Michael Smith, P h.D. FDA-CBER-2021-5683-1150807

125742 S63 M1 response 18aug2021

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

COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 18 August 2021  Information Request: DBSQC Comments PFIZER CONFIDENTIAL Page 1QUERY 1 In amendment 54 to BLA STN 125742/0 (Seq 0056, dated 08/17/2021), you agreed to perform an endotoxin test and explained y ou will establish the method and perform verification studies at y our drug product release testing facilities. Please submit information and data to support this method along with a draft updated lot release protocol…

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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 19August 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 S61 M1 response 17aug2021

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

COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 17 Aug 2021 FDA queries –Shelf -life and date of manufacture PFIZER CONFIDENTIAL Page 1QUERY 1 Please send information on what y our final, intended drug product shelf life will be and commit to submitting stability data in real time post licensure to support this requested shelf life. Response 1 The final commercial shelf life of the BNT162b2 drug product presently is inte nded to be 24 months when stored at the intended…

125742 S61 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 19August202 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 S60 M3 32s2 control critical steps manuf process

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

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…