Pfizer Documents (PHMPT/FDA)
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BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 1PHARMACOVIGILANCE PLAN FOR BIOLOGIC LICENSE APPLICATION #125742 OF COVID-19 mRNA vaccine (nucleoside modified) (BNT162b2, PF -07302048) Date of Report: 28JULY2021 Version 1.1 090177e197aab463\Approved\Approved On: 28-Jul-2021 16:51 (GMT) FDA-CBER-2021-5683-0651271 BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 2TABLE OF CONTENTS…
Pfizer Documents (PHMPT/FDA)
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COVID-19 Vaccine (BNT162, PF-07302048) BB-IND 019736 Agreed Initial Pediatric Study Plan PFIZER CONFIDENTIAL Page 1 of 22 AGREED INITIAL PEDIATRIC STUDY PLAN ( iPSP) Product : COVID-19 Vaccine (BNT162, PF-07302048) Dosage Form : Liquid formulation for i ntramuscular injection IND # : 019736 Drug Class : Vaccine Approved Indication : Not applicable Proposed Initial Indication : Active immunization again st COVID-19 in individuals ≥16 years of age Proposed Supplemental…
Pfizer Documents (PHMPT/FDA)
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COVID-19 Vaccine (BNT162, PF-07302048) BB-IND 019736 Agreed Initial Pediatric Study Plan PFIZER CONFIDENTIAL Page 1 ATTACHMENT A — DEFERRAL REQUEST Product Name COVID-19 Vaccine (BNT162, PF-07302048) IND number 019736 Applicant BioNTech Proposed Initial Indication Ac tive immunization against COVID- 19 in individuals ≥16 years of age Future Supplemental Indications Active immunization against COV ID-19 in children and adolescents 12 through 15 years of age; Active …
Pfizer Documents (PHMPT/FDA)
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Compound: PF -07302048; Protocol: C4591001 Page 1of 4 Reason(s) for Narrative: HIV Unique Subject ID: C4591001 1226 12262255; Country: Brazil Vaccine Group (as Administered): BNT162b2 (30 μg) Date of First Dose: 16OCT2020; Date of Last Dose: 06NOV2020 ============================================================================================================= ============= PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: dm, vs, mh, ex, ae, cm, ds Output File: …
Pfizer Documents (PHMPT/FDA)
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Listing of Severe, Serious, Life threatening, or Leading to Withdrawal Adverse Events From Dose 1 to Unblinding Date – Blinded Placebo -Controlled Follow -up Period – Phase 2/3 HIV -Positive Subjects ≥16 Years of Age – Safety Populatio n Treatment Group/ Age Group (Years)/ Subject System Organ Class Preferred Term/ AE Investigator Text Dose No. Onset Date Rel Daya/ Dur (Days)b Toxicity Grade Vax Relc Cause of AE Action: Investigational Vaccine Dose/ Subject…
Pfizer Documents (PHMPT/FDA)
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BNT162b2 BLA 125742 Module 1.12.5Request for a Waiver Exceptionto 21CFR 610.15(a) Requirement for a Preservative PFIZER CONFIDENTIAL Page 1Request for a Waiver COVID-19 Vaccine BNT162 (PF-07302048) Request for Ex ception to the 21CFR610.15(a) Requirement for a Preservative JULY 2021 090177e19791beba\Approved\Approved On: 15-Jul-2021 19:51 (GMT) FDA-CBER-2021-5683-0651236 BNT162b2 BLA 125742 Module 1.12.5Request for a Waiver Exceptionto 21CFR 610.15(a) Requirement for a Preservative …
Pfizer Documents (PHMPT/FDA)
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COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 13Jul 2021FDA queries –Preservative Exception or Alternative PFIZER CONFIDENTIAL Page 1QUERY 1 COMIRNATY is supplied in a multiple -dose vial that does not contain a preservative. Our review of the information provided in your BLA STN 125742/0 for COMIRNATY (COVID - 19 mRNA Vaccine), for active immunization to prevent COVID -19 caused by SARS-CoV-2 in individuals 16 y ears of age and older, is ongoing. Please note that 21…
Pfizer Documents (PHMPT/FDA)
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BNT162b 2BLA STN 1255742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1BNT162b2 BLA STN 125842/0 Response to CBER 08 June 2021 Clinical Information Request June 2021 090177e19751ff52\Approved\Approved On: 16-Jun-2021 16:36 (GMT) FDA-CBER-2021-5683-0651232 BNT162b 2BLA STN 1255742/0 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 21.INTRODUCTION On 08 June 2021, Pfizer /BioNTech received the following C linical Information R…
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Listing of Subjects and SARS -CoV -2 Variants With First COVID -19 Occurrence From 7 Days After Dose 2 and With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Blinded Placebo -Controlled Follow -up Period – Evaluable Efficacy (7 Days) Population ......................................................... 2 Listing of Subjects and SARS -CoV -2 Variants With Multi ple COVID -19 Occurrence After Dose 1 – Dose 1 All -Available Efficacy Population ............... 260 Listing…
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C4591001 Page 1 of 26 CONFIDENTIAL 26-Mar-2021 09:43:07 GMT16.1.3.1 LIST OF INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB) ARGENTINA Study Site Number Independent Ethics Committee or Institutional Review Board Address(es) 1231 Comité Institucional de Revisión de Ensayos Clínicos (C.I.R.E.C.) del Hospital Militar Central "Cirujano Mayor Dr Cosme Argerich" Av. Luis María Campos 726, Edificio PACE Piso 5 CABA, 1426 ARGENTINA090177e196a1cc59\Approved\Approved On:…
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 CBER22 July 2021 Information Request Regarding ClinicalShellTablesfor Study C4591001 Follow-Up #2 August 2021 090177e197b61a4e\Approved\Approved On: 02-Aug-2021 19:22 (GMT) FDA-CBER-2021-5683-0651476 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 21.INTRODUCTION Reference is made to BLA STN…
Pfizer Documents (PHMPT/FDA)
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Transmittal Memo TO: Lorrie McNeill DirectorOffice of Communication, Outreach and Development FROM: Marion F. Gruber, Ph.D. DirectorOffice of Vaccines Research and Review RE: Action Package for: STN 125742/0, COVID-19 Vaccine, mRNA (COMIRNATY) DATE: August 23, 2021 Office Point of Contact: Laura Gottschalk, Ph.D. Please include the following information for posting on Web pages: Proper Name: COVID-19 Vaccine, mRNA Tradename: COMIRNATYManufacturer: BioNTech Manufacturing GmbHIndication:…
Pfizer Documents (PHMPT/FDA)
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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID-19 V accine, mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 ------------------------------- INDICAT IONS AND USAGE ------------------------------ COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMIRNATY 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 ------------------------------ COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMIRNATY 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 ------------------------------ COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMIRNATY 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 ------------------------------ COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
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1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMIRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: YYYY -------------------------------INDICATIONS AND USAGE ------------------------------ COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused…
Pfizer Documents (PHMPT/FDA)
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1 From: Marion Gruber, PhD, Director, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research To: BLA STN 125742 /0 Date: August 17, 2021 Subject: Rationale for designat ion of a nonproprietary name for COVID -19 Vaccine, mRNA (Comirnaty ) that does not include a distinguishing suffix Introduction: BioNTech Manufacturing GmbH has submitted a Biologics License Application for a COVID - 19 vaccine (STN 125742 , Action Due Date…
Pfizer Documents (PHMPT/FDA)
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August 17, 2021 Please Note, The lots below are associated with this Supplement. The lot(s) associated with this BLA/supplement will be released upon completion of protocol review, any requested sample testing and approval of the BLA/supplement. Since lots are associated with this BLA/supplement please be sure to provide a copy of the signed approval to the Product Release Branch by fax to 301.594.6924 or e- mail the letter to CBER Lot Clearance. STN Supp. # …
Pfizer Documents (PHMPT/FDA)
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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMIRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: YYYY ------------------------------- INDICATIONS AND USAGE ------------------------------ COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…