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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 02 August 2021 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 …
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 03August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics 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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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 28 July2021Information Request Regarding Post- marketing SafetyStudy(ies) August2021 090177e197b93e4d\Approved\Approved On: 03-Aug-2021 22:37 (GMT) FDA-CBER-2021-5683-0950173 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS 1. INTRODUCTION ................................…
Pfizer Documents (PHMPT/FDA)
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FDA-CBER-2021-5683-0950865 Marion Gru ber, Ph.D. , Director Page 2of 2 BLA 125742 05August 2021 Pfizer Confid ential Page 2Elisa Harkins Global R egulatory Lead Global R egulator y Aff airs –Vaccine s CC:Ramac handr a S. Naik, Ph.D. FDA-CBER-2021-5683-0950866
Pfizer Documents (PHMPT/FDA)
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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 02 August 2021 CBER Information Request Regarding Validation Report VR -MVR -10077 05August 2021 090177e197bd9b0d\Approved\Approved On: 05-Aug-2021 14:15 (GMT) FDA-CBER-2021-5683-0950867 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS LIST OF ABBREVIATION…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 05August 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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BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER 22 July 2021 Information Request Regardin g Clinical ShellTables for Study C4591001 Follow -Up #3 (Efficacy 508 Tables) Response to CBER 03 August 2021 Information Request Regarding Subject C4591001 1001 10031167 and SAS programs July 2021 090177e197bda631\Approved\Approved On: 05-Aug-2021 14:41 (GMT) FDA-CBER-2021-5683-0950192 BNT162b2 BLA STN…
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August 23, 2021 RE: Pfizer-BioNTech COVID-19 Vaccine IMPORTANT PRODUCT INFORMATION Certain Pfizer-BioNTech COVID-19 Vaccine Lots authorized for Emergency Use comply with the Biologics License Application (BLA) Dear Healthcare Professional, Pfizer, Inc. would like to provide you with updated and very important information related to the Pfizer-BioNTech COVID-19 Vaccine, authorized for emergency use by FDA under an Emergency Use Authorization (EUA). On August 23, 2021, FDA approved BioNTech’s…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 09August 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 Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 11August 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 LICENSING AND/OR…
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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 10 August 2021 Information R equest Regarding Post- marketing Safety Studies August 2021 090177e197c983f5\Approved\Approved On: 11-Aug-2021 17:24 (GMT) FDA-CBER-2021-5683-0950213 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 -BioNTech COVID -19 vaccine C4591021 NON -INTERVENTIONAL STUDY PROTOCOL Version 2 (20May 2021) PFIZER CONFIDENTIAL CT24- WI-GL02 -RF02 2 .0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 01-Jun-2020 Page 1NON- INTERVENTIONAL (NI) STUDY PROTOCOL PASS information Title Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer- BioNTech Coronavirus Disease 2019 ( COVID -19) Vaccine Protocol number C4591021…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 12August 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 LICENSING AND/OR…
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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 09 August 2021 CBER Information Request Regarding Sequencing Data August 2021 090177e197c9be34\Approved\Approved On: 11-Aug-2021 19:14 (GMT) FDA-CBER-2021-5683-0950306 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS 1. INTRODUCTION ................................…
Pfizer Documents (PHMPT/FDA)
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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 SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 16August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics 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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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 13 August 2021 CBER Information Request Regarding Duration of Follow-up in Study C4591001 (16+ Years of Age) August 2021 090177e197d2750a\Approved\Approved On: 16-Aug-2021 18:27 (GMT) FDA-CBER-2021-5683-0950317 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2TABLEOF CONTENTS LIST OF…
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 16August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics 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…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 16August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics 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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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 13 August2021 Information Request Regarding Safety-RelatedPostmarketing Requirement/Postmarketing Commitment S tudies 16 August 2021 090177e197d286d0\Approved\Approved On: 16-Aug-2021 18:19 (GMT) FDA-CBER-2021-5683-0950338 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS 1.…