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BNT162b2 BLA 125742 Request for Proprietary & Non -Proprietary Name Revie w PFIZER CONFIDENTIAL Page 1REQUEST FOR PROPRIETARY & NON -PROPRIETARY NAM E REVIEW 090177e19710b69e\Final\Final On: 19-May-2021 01:15 (GMT) FDA-CBER-2021-5683-0780560 BNT162b2 BLA 125742 Request for Proprietary & Non -Proprietary Name Revie w PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS 1. APPLICANT CONTACT INFORMATION ................................ ................................ ......... 3 2. PROPOSED PRI MARY AND…
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 19May2021 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 …
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PRIVATE AND CONFIDENTIAL Avon CAP Study Protocol Version 2.2| 30thJanuary 2021 IRAS 283899 Page 1of 65 UOB ConfidentialUOB Confidential Avon Community Acquired Pneumonia Study (Avon CAP): APan-pandemic Acute Lower Respiratory Tract Disease Surveillance Study Protocol Version 2.2 Protocol Date 30/01/2021 Sponsor University of Bristol Funder Pfizer Study Co -ordinating Centre Bristol Children’s Vaccine Centre…
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Pfizer -BioNTech COVID -19 Vaccine C4591022 NON -INTERVENTIONAL STUDY PROTOCOL SYNOPSIS 14April 2021 PFIZER CONFIDENTIAL Page 1of 12NON- INTERVENTIONAL (NI) STUDY PROTOCOL SYNOPSIS Study information Title Pfizer -BioNTech COVID-19 Vaccine Exposure during Pregnancy : A Non-Interventional Post - Approval Safet y Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTI S)/MotherToBab y Pregnancy Registry Protocol number C4591022 Date 14April…
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BNT162b2 C4591014 NON- INTERVENTIONAL STUDY PROTOCOL Version 1.0, 22March 2021 PFIZER CONFIDENTIAL CT24- WI-GL02 -RF02 2.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 15-Aug-2018 Page 1 of 42NON -INTER VENTIONAL (NI) STUDY PROT OCOL This document contains confidential information belonging to Pfizer. Except as otherw ise agreed to in w rit- ing, by accepting or reviewing this document, you agree to hold this information in confidence and not copy or …
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BNT162b2 (COVID -19 vaccine) C4591012 NON- INTERVENTIONAL STUDY PROTOCOL Final Version 1.0, 27 January 2021 PFIZER CONFIDENTIAL Page 1of 144NON- INTERVENTIONAL ( NI) STUDY CONCEPT PR OTOCOL Title Post-Emergency Use Authorization Active Safety Surveillance Study among Individuals in the Veteran ’s Affairs Health Sy stem Receiving Pfizer -BioNTech Coronavirus Disease 2019 (COVID -19) Vaccine Protocol number C4591012 Protocol version identifier Final Version 1.0 Date of last version of…
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BNT162b2 (COVID -19 vaccine) C459101 1NON -INTERVENTIONAL STUDY PROTOCOL Version 1.0, 29 January 2021 PFIZER CONFIDENTIAL Page 1of 170NON- INTERVENTIONAL ( NI) STUDY CONCEPT PR OTOCOL Title Active Safet y Surveillance of the Pfizer - BioNTech COVID -19 Vaccine in the U nited States Department of Defense Population Following Emergency Use Authorization Protocol number C4591011 Protocol version identifier Final Version 1.0 Date of last version of protocol 29January 2021 EUPost Authori zation…
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COVID -19 m RNA Vaccine C4591009 NON -INTERVENTIONAL STUDY PROTOCOL SYNOPSIS Version 1.0, 01 April 2021 PFIZER CONFIDENTIAL Page 1of 25Study information Title A Non -Interventional Post- Approval Safet y Study of the Pfizer -BioNTech COVID -19 mRNA V accine in the United States. Protocol number C4591009 Protocol synopsis version identifier 1.0 Date 01 April 2021 EU Post Authoriz ation Study, PAS register numberTo be registered before the start of data collection Active substance COVID -19…
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Pfizer -BioNTech COVID- 19 Vaccine C4591008 NON- INTERVENTIONAL STUDY PROTOCOL V2.0, 27 January 2021 PFIZER CONFIDENTIAL Page 1 of 42 NON- INTERVENTIONAL (NI) STUDY PROTOCOL Study Information Title HERO Together : A post-Emergency Use Authorization observational cohort study to evaluate the safety of the Pfizer -BioNTech COVID-19 vaccine in US h ealthcare workers Protocol number C4591008 Protocol version identifier Version 2.0 Date 27 January 2021 EU Post…
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PF-07302048 (BNT162 RNA- Based COVID- 19 Vaccines) Protocol C4591015 Protocol Amendment 2, 02March 2021 PFIZER CONFIDENTIAL CT02- GSOP Maternal Immunization Protocol Template (Phase 1 2 3 4) (15 May 2020) TMF Doc ID: 164.01 Page 1A PHASE 2/3,PLACEBO -CONTROLLED, RANDOMIZED, OBSERVE R-BLIND STUDY TO EVALUATE TH E SAFETY, TOLERABILI TY,AND IMMUNOGEN ICITY OF A SARS -COV -2 RNA VACCI NE CANDIDATE (BNT162b 2) AGAINST COVID -19 IN HEALTHY PREGNANT WOMEN 18 YE ARS OF AGE AND OLDER Study Sponsor:…
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PF-07302048 (BNT162 b2 RNA- Based COVID -19 Vaccine) Protocol C4591007 Protocol Amendment 1 , 05March 2021 PFIZER CONFIDENTIAL CT02- GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 1A PHASE 1 ,OPEN-LABEL DOSE -FINDING STUDY TO EVALUATE S AFETY, TOLERABILITY , AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO -CONTROLLED, OBSERVER- BLINDED SAFETY, TOLERABILIT Y, AND IMMUNOGENICITY STUDY OF A SARS -COV -2 RNA VACCI NE CANDIDATE AGAINST CO VID-19 IN HEALTHY CHILDREN <12YEARS OF AGE…
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BNT162b2 Module 1.14.1.5 Request for Waiver of Pregnancy Registry Report CONFIDENTIAL Page 1REQUEST FOR WAIVER OF PREGNANCY REGISTRY R EPORT Part V of Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Draft Guidance for Industry dated July 2020 request s the Sponsor to file a n interim report of an ongoing registry or a final report on a closed pregnancy registry (if applicable) or other study . Pfizer…
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BNT162b2 Module 1.14.1.5 Request for Waiver for Summary of Drug Utilization Rates CONFIDENTIAL Page 1REQUEST FOR WAIVER FOR SUMMARY OF DRUG UTILIZATION RATES Part V of Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Draft Guidance for Industry dated July 2020 request s the Sponsor to file a summary of drug utilization rates among females of reproductive potential ( ie, aged 15 to 44 years) calculated…
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BNT162b2 Module 1 .14.1.5 Summary of Literature Search on Pregnancy, Lactation, and Reproductive Potential CONFIDENTIAL Page 1Coronavirus D isease 2019 (COVID -19) Vaccine Summary of Literature Search on the Use of Coronavirus Disease 2019 (COVID -19) Vaccine During Pregnancy, Lactation, and on the Drug’s Potential Effects on Fertility 090177e196d37d8f\Approved\Approved On: 20-Apr-2021 16:12 (GMT) FDA-CBER-2021-5683-0779753 BNT162b2 Module 1 .14.1.5 Summary of Literature Search on Pregnancy,…
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BNT162b2 Cumulative Review from Pharmacovigilance Database CONFIDENTIAL Page 1PREGNANCY AND LACTAT ION CUMULATIVE REVIEW 090177e196d38ee9\Approved\Approved On: 20-Apr-2021 16:11 (GMT) FDA-CBER-2021-5683-0779745 BNT162b2 Cumulative Review from Pharmacovigilance Database CONFIDENTIAL Page 21.INTRODUCTION As part of the Biological Licensing Application (BLA) submission, the U.S. Food and Drug Administration (FDA) has requested a cumulative review and summary of relevant cases reported in…
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Ref: Letter DMF Format Update November 2, 2015 Primary Packaging Glass Re: Letter of Authorization to reference Type III DMF #9543 Type I Tubular Containers Gerresheimer Glass Inc. hereby authorizes Pfizer Inc. as US Agent for BioNTech RNA Pharmaceuticals GmbH, 500 Arcola Road, Collegeville, PA 19436 to incorporate by refe rence DMF 9543 into any IN D, NDA, ANDA, IDE, PMA, ANADA, BLA or DMF filed by Pfizer, Inc. . DMF 9543 was filed by Gerresheimer Glass Inc. on February…
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BNT162b2 M 1.1 4.1 Draft Labeling CONFI DENTIAL 1BNT162b2 -BLA 125742 Diluent Labeling May 2021 090177e19709d21c\Approved\Approved On: 17-May-2021 21:11 (GMT) FDA-CBER-2021-5683-0779740 BNT162b2 M 1.1 4.1 Draft Labeling CONFI DENTIAL 21.INTRODUCTION Reference is made to the following: Pfizer/BioNTech Briefing Document sub mitted 18 February 2021 to BB -IND 19736 for a T ype C Meeting regarding the Read y-to-Use (RTU) and l yophilized formulations of the BNT162b2 vaccine. CBER’s 10 March…
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PFIZER GENERAL BUSINESS The official version o f this form is located in the electronic document management system. Page 1of 6Pfizer -BioNTech COVID- 19Vaccine VAED Data C apture Aid Instructions for use: This Da ta Capture Aid ( DCA )is intended to capture the available clinical details about the nature and severity of COVID -19 illness experienced ,particularly in relation to potential cases of vaccine lack of effect o rvaccine associ ated enhanced disease (VAED) . Select qu estions as…
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PFIZER GENERAL BUSINESS Theofficial ve rsion of this form is located in the electronic do cument ma nagement system. Page 1of 5Pfizer -BioNTech COVID -19VaccineAnaphylactic Reaction Data C apture Aid Instructions for use: This Da ta Capture Aid ( DCA )is intended to enable the retrieval of clinical details about potential anaphylactic reaction sexperienced by an individual following administration of Pfizer- BioNTech COVID -19 Vaccin e. Select qu estions as needed to obtain any DCA -defined…
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 18May2021 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 …