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FDA-CBER-2021 5683 0950877 Digitally signed by DN o=Pfizer Inc cn Reason I am signing on behalf of Donna Boyce Location Date 2021.08.27 09 05 18 0800' (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0950878
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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125742 S65 M1 eua lab 1450 12 0
Revised: 23August 2021 1FACT SHEET FOR HEA LTHCA RE PROVIDERS A DMINISTERING VA CCINE (VACCINA TION PROVIDERS) EMERGENCY USE AUTHORIZA TION (EUA) OF THE PFIZER -BIONTECH COVID -19 VA CCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) The U.S. Food and Drug A dministration (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 ind ividuals…
125742 S65 M1 eua lab 1451 8 0
1 Revised: 23August 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 SARS-CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for…
125742 S65 M1 lab 1448 1 0
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
125742 S65 M1 pp cvv usa 0349 01
FDA-CBER-2021-5683-0950948 FDA-CBER-2021-5683-0950949 FDA-CBER-2021-5683-0950950 FDA-CBER-2021-5683-0950951 FDA-CBER-2021-5683-0950952 FDA-CBER-2021-5683-0950953 FDA-CBER-2021-5683-0950954 FDA-CBER-2021-5683-0950955 FDA-CBER-2021-5683-0950956 FDA-CBER-2021-5683-0950957 FDA-CBER-2021-5683-0950958 FDA-CBER-2021-5683-0950959 FDA-CBER-2021-5683-0950960 FDA-CBER-2021-5683-0950961 FDA-CBER-2021-5683-0950962 FDA-CBER-2021-5683-0950963 FDA-CBER-2021-5683-0950964 • are immunocompromised or are on a…
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FDA-CBER-2021 5683 0951043 D gi a ly signed by DN c o Pf zer Inc. ou=PPLS - ou Submissions and Operations Support cn Reason I am signing on behalf Donna Boyce Location Date 2021 08.26 0 10 16 0 00 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0951044
125742 S66 M1 eua lab 1450 12 0
Revised: 23August 2021 1FACT SHEET FOR HEA LTHCA RE PROVIDERS A DMINISTERING VA CCINE (VACCINA TION PROVIDERS) EMERGENCY USE AUTHORIZA TION (EUA) OF THE PFIZER -BIONTECH COVID -19 VA CCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) The U.S. Food and Drug A dministration (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 ind ividuals…
125742 S66 M1 eua lab 1451 8 0
1 Revised: 23August 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 SARS-CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for…
125742 S66 M1 lab 1448 1 0
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
125742 S66 M1 pp cvv usa 0357
All anchors within the website link to the beginning of that specified page, unless related to a specific q&a Drives to USPI (16+) - http:// labeling.pfizer.com/ ShowLabeling.aspx? id=15623 Drive to FAQ page question "What is the difference between FDA approval and an EUA" on pg. 45 Url flat annotations are provided at first mention Downloadable resources flat annotations providing CBER with copy to APLB submission date provided at first mention Persistent ISI is available at…
125742 S67 M1 attachment hcp letter
August XX, 2021 RE: Pfizer-BioNTech COVID-19 Vaccine Now FDA Approved as COMIRNATY® IMPORTANT PRODUCT INFORMATION Specified Pfizer-BioNTech COVID-19 Vaccine Lots authorized for Emergency Use comply with the approved specifications in Biologics Licensing 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 (now FDA approved as COMIRNATY®). The…
125742 S67 M1 attachment infographic lots
090177e197da5064\Approved\Approved FDA-CBER-2021-5683-0951264
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 19August2021 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 S67 M1 response 18aug2021
BNT162b2 BLA STN 125742/0 M 1.11.4Response to FDA Information Request PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER 18 August2021 Information Request Regarding Identification of BLA CompliantLots and Dear HCP Letter 19August 2021 090177e197da0346\Approved\Approved On: 19-Aug-2021 13:11 (GMT) FDA-CBER-2021-5683-0951267 BNT162b2 BLA STN 125742/0 M 1.11.4Response to FDA Information Request PFIZER CONFIDENTIAL Page 21.INTRODUCTION Reference is made to BLA STN…
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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 SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
125742 S69 M1 cover
Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 19August2021 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 S69 M1 response 19aug2021
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 19 August2021 Information Request Regarding Postmarketing Requirement/Postmarketing Commitment S tudies 19August 2021 090177e197daf1b4\Approved\Approved On: 19-Aug-2021 19:38 (GMT) FDA-CBER-2021-5683-0950378 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 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 S27 M1 cover
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 …
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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 …