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

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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 20August 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 SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …

125742 S75 M1 response 20aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 4 pages

BNT162b2 BLA STN 125742/0 M 1.11. 4Response to FDA Information Request PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to 20 August CBER Information Request Regarding Label for Identification of BLA Lots and Dear HCP Letter 20 August 2021 090177e197dd9261\Approved\Approved On: 20-Aug-2021 21:19 (GMT) FDA-CBER-2021-5683-0951277 BNT162b2 BLA STN 125742/0 M 1.11. 4Response to FDA Information Request PFIZER CONFIDENTIAL Page 2LIST OF ABBREVIATIONS Abbreviation Term BLA…

125742 S76 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 21August2021 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 …

125742 S77 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 21August2021 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 …

125742 S77 M1 response 21aug2021 attachment pmc

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 5 pages

BNT162b2 BLA STN 125742 /0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1Response to CBER 21 August 2021 Information Request Regarding Postmarketing Requirement/Postmarketing Commitment S tudies Final List of Studies 21August 2021 090177e197ddf480\Approved\Approved On: 21-Aug-2021 18:36 (GMT) FDA-CBER-2021-5683-0950407 BNT162b2 BLA STN 125742 /0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2FINAL LIST OF STUDIES 1.Deferred pediatric Stud y…

125742 S77 M1 response 21aug2021 pmc

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 10 pages

BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER 21 August2021 Information Request Regarding Postmarketing Requirement/Postmarketing Commitment S tudies 21August 2021 090177e197de0add\Approved\Approved On: 21-Aug-2021 18:36 (GMT) FDA-CBER-2021-5683-0950412 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS 1. INTRODUCTION…

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

1 Revised: 22September 2021VACCINE INFORMA TION FACT SHEET FOR REC IPIENTS AND CA REGIVERS ABOUT COMIRNA TY (COVID -19 VA CCINE, mRNA ) ANDPFIZER -BIONTECH COVID -19 VACCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) You are being offered either COMIRNA TY (COVID -19 Vaccine, mRNA ) or the Pfizer-BioNTech COVID- 19 Vaccine to prevent Coronavirus Disease 2019 (COVID -19)caused by S ARS -CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 48 pages

Revised: 22 September 2021 1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EM ERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER -BIONTECH COVID- 19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer -BioNTech COVID- 19 Vaccine, for active immunization to prevent COVID -19 in individuals 12…

125742 S2 M3 32s2 manufacturer

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

BNT162b2 3.2.S.2. 1Manufacturer(s) PFIZER CONFIDENTIAL Page 13.2.S.2.1. MANUFACTURER(S) Table 3.2.S.2.1 -1 lists the sites that have responsibilities in the production of BNT162b2 drug substance and their specified functions. Table 3.2.S.2.1-1. Sites and Responsibilities for Manufacture and Testing of BNT162b 2 Drug Substance Site FEI / DUNS Numbers Responsibility (Pfizer, Andover, ) (Pfizer, Andover Building Building and Building Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLCa…

125742 S2 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…

125742 S2 M3 32r reg info manufacturing schedules

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

BNT162b2 3.2.R Manufacturing Schedules PFIZER CONFIDENTIAL Page 13.2.R.2. MANUFACTURING SCHEDULES Due to the urgent need for pandemic supplies the , Kalamazoo and Puurs facilities expect to be in routine production weekl y through October 2021 with the following exceptions for the facility : 090177e197033d9f\Approved\Approved On: 12-May-2021 05:44 (GMT) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1149288

125742 S2 M3 32r reg info lot release documentation package

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 6 pages

TABLE OF CONTENTS LOT RELEASE DOCUMENTATION PACKAGE ............................................................... 3 090177e196fd19b4\Approved\Approved On: 10-May-2021 08:42 (GMT) FDA-CBER-2021-5683-1149282 Pfizer Global Supply , 7000 Portage Rd. Kalamazoo, MIC 49001 USA Page 1 of 1 Date: Food and Drug Administration Center for Biologics Evaluation and Research Sample Custodian 10903 New Hampshire Avenue W075 -G707 Silver Spring, MD 20993 -0002 Please…

125742 S2 M3 32p53 validation analytical procedures overview

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

BNT162b2 3.2.P.5.3 Validation of Analytical Procedures Overvie w PFIZER CONFIDENTIAL Page 13.2.P.5.3. OVERVIEW Validation of anal ytical procedures was performed to ensure the composition, strength , identity , potency , purit y, and safet y of BNT162b2 drug product. All non -compendial and compendial a nalytical procedures were confirmed suitable for their intended use . Analy tical procedures were validated against the parameters presented in ICH Q2(R1), Validation of Anal ytical…

125742 S2 M3 32p53 validation analytical procedure rt pcr

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

BNT162b2 3.2.P.5.3 Validation of Analytical Procedures Reverse Transcription -Polymerase Chain Reaction (RT -PCR) PFIZER CONFIDENTIAL Page 13.2.P.5.3. REVERSE TRANSCRIPTIO N-POLYMERASE CHAIN R EACTION (RT-PCR) 090177e195573d32\Approved\Approved On: 24-Oct-2020 06:09 (GMT) (b) (4) FDA-CBER-2021-5683-1149280

125742 S2 M3 32p53 validation analytical procedure cap gel electro

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

BNT162b2 3.2.P.5.3 Validation of Analytical Procedures Capillary Gel Electrophoresis PFIZER CONFIDENTIAL Page 13.2.P.5.3. CAPILLARY GEL ELECTROPHORESIS 090177e195573d36\Approved\Approved On: 24-Oct-2020 06:09 (GMT) (b) (4) FDA-CBER-2021-5683-1149279

125742 S2 M3 32p52 analytical procedure subvis particulate matter

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

BNT162b2 3.2.P.5.2 Analytical Procedures Subvisible Particulate Matter PFIZER CONFIDENTIAL Page 13.2.P.5.2. SUBVISIBLE PARTICULATE MATTER The anal ytical procedure for measuring subvisible particulate matter in BNT162b2 drug product is performed using the test in accordance with USP <787>and Ph. Eur. 2.9.19. 090177e19700aef1\Approved\Approved On: 12-May-2021 07:26 (GMT) (b) (4) FDA-CBER-2021-5683-1149278

125742 S2 M3 32p52 analytical procedure rt pcr

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

BNT162b2 3.2.P.5.2 Analytical Procedures Reverse Transcription -Polymerase Chain Reaction (RT -PCR) PFIZER CONFIDENTIAL Page 13.2.P.5.2. REVERSE TRANSCRIPT ION -POLYMERASE CHAIN REA CTION (RT-PCR) 090177e19700b028\Approved\Approved On: 12-May-2021 07:27 (GMT) (b) (4) FDA-CBER-2021-5683-1149277

125742 S2 M3 32p52 analytical procedure overview

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

BNT162b2 3.2.P.5.2 Analytical Procedures Overview PFIZER CONFIDENTIAL Page 13.2.P.5.2. OVERVIEW Analy tical procedures that are and are detailed in this section. As requested b y FDA, the analy tical standard opera ting procedures a re presented in Section 3.2.R Standard Operating Procedures, Method Validation and Transfer Reports . 090177e19700a83b\Approved\Approved On: 12-May-2021 07:26 (GMT) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1149276

125742 S2 M3 32p52 analytical procedure osmometry

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

BNT162b2 3.2.P.5.2 Analytical Procedures Osmometry PFIZER CONFIDENTIAL Page 13.2.P.5.2. OSMO METRY The anal ytical procedure for measuring the osmolality of the BNT162b2 drug product is performed using freezing point depression in accordance with USP <785>. The method is also performed in accordance with Ph .Eur.2.2.35 with slight differences in instrument calibration. 090177e195d53594\Approved\Approved On: 18-Dec-2020 07:11 (GMT) FDA-CBER-2021-5683-1149275

125742 S2 M3 32p52 analytical procedure endotoxin

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

BNT162b2 3.2.P.5.2 Analytical Procedures Endotoxin PFIZER CONFIDENTIAL Page 13.2.P.5.2. ENDOTOXIN Endotoxin testing for BNT162b2 drug product is performed using a limulus amebocy te lysate (LAL) anal ytical procedure in accordance with USP <85> , Ph. Eur. 2.6.14 and JP 4.01. 090177e19700b009\Approved\Approved On: 12-May-2021 07:27 (GMT) (b) (4) FDA-CBER-2021-5683-1149274