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 16June2021 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 …

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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 17June 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologic s 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 …

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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 2 July 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 S9 M1 response 29jun2021

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

BNT162b 2BLA STN 125742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1BNT162b2 BLA STN 1257 42/0 Response to CBER 29June2021 Clinical Information Request July2021 090177e197761bcb\Approved\Approved On: 02-Jul-2021 08:26 (GMT) FDA-CBER-2021-5683-0950055 BNT162b 2BLA STN 125742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 21.INTRODUCTION On 29June 2021, Pfizer /BioNTech received the following C linical Information R…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 17 pages

BioNTech SE / Tables - Final 1.0 BNT162b2 BNT162 -01 Created on 30JUN2021 Page 1 of 16 Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Table of content 14.3 Safety ................................ ................................ ................................ ................................ ................................ ................................ ................................ ....2 14.3.1 Primary endpoints…

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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 2 July2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologicsEvaluation 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 S10 M1 response 25jun2021

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

BNT162b 2BLA STN 125742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1BNT162b2 BLA STN 1257 42/0 Response to CBER 25 June2021 Clinical Information Request July2021 090177e197779ef8\Approved\Approved On: 02-Jul-2021 15:04 (GMT) FDA-CBER-2021-5683-0950077 BNT162b 2BLA STN 125742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 21.INTRODUCTION On 25June 2021, Pfizer /BioNTech received the following C linical Information R…

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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 15 July2021 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 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 16July2021 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 …

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

BNT162b 2BLA STN 125742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1BNT162b2 BLA STN 1257 42/0 Response to CBER 06July 2021 Clinical Information Request July2021 090177e197918386\Approved\Approved On: 15-Jul-2021 16:12 (GMT) FDA-CBER-2021-5683-0950085 BNT162b 2BLA STN 125742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 21.INTRODUCTION On 06July2021, Pfizer /BioNTech received the following C linical Information R…

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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 23July2021 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 S16 M1 ped studies deferral req

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

COVID -19Vaccine (BNT162 ,PF-07302048 ) BB-IND 019736 Agreed Pediatric Study Plan PFIZER CONFIDENTIAL Page 1ATTACHMENT A—DEFERRAL REQUEST Product Name COVID -19 Vaccine (BNT162, PF -07302048) IND number 019736 Applicant BioNTech Proposed Initial Indication Active immunization against COVI D-19 in individuals ≥16years of age Future Supplemental Indications Active immunization against COVI D-19 in children and adolescents 12through 15 years of age; Active immunization against COVID -19 in…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 23 pages

COVID -19Vaccine (BNT162 ,PF-07302048 ) BB-IND 019736 Agreed Pediatric Study Plan PFIZER CONFIDENTIAL Page 1of 22AGREED PEDIATRIC STUDY PLAN (PSP) Product :COVID -19 Vaccine (BNT162, PF -07302048) Dosage Form : Liquid formulation for intramuscular injection IND # : 019736 Drug Class : Vaccine Approved Indication : Not applicable Proposed Initial Indication : Active immunization against COVI D-19 in individuals ≥16yearsof age Proposed Supplemental Indication s: Active immunization against COVID…

125742 S16 M1 response 15jul2021

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

BNT162b 2 BLA STN 125742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1BNT162b2 BLA STN 1257 42/0 Response to CBER 15July 2021 Clinical Information Request July2021 090177e197a0ac7b\Approved\Approved On: 22-Jul-2021 22:11 (GMT) FDA-CBER-2021-5683-0950117 BNT162b 2 BLA STN 125742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 21.INTRODUCTION On 15July2021, Pfizer /BioNTech received the following C linical Information R…

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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 26July2021 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 S18 M1 response 22jul2021

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 1BNT162b2 (COMIRNATY) BLASTN 125742/0 Response to CBER 22 July2021Information Request Regardin g ClinicalShellTablesfor Study C4591001 July2021 090177e197a554b5\Approved\Approved On: 26-Jul-2021 11:35 (GMT) FDA-CBER-2021-5683-0950123 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL 2TABLE OF CONTENTS 1. INTRODUCTION ................................…

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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 28July 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologic s 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 S20 M1 response 22jul2021

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

BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA I nformation Request PFIZER CONFIDENTIAL 1BNT162b2 (COMIRNATY) BLASTN 125742/0 Response to CBER 22 July2021Information Request Regardin g ClinicalShellTablesfor Study C4591001 Follow-Up #1 July2021 090177e197a8b052\Approved\Approved On: 27-Jul-2021 19:43 (GMT) FDA-CBER-2021-5683-0950135 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA I nformation Request PFIZER CONFIDENTIAL 2TABLE OF CONTENTS 1. INTRODUCTION ................................…

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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 29July 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 …

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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 30July2021 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 …