125742 45 S211 M1 financial cert 3454
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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 45 08 02 2022 Memo Committee Memo Revie
STN 125742/45: BioNTech Manufacturing GmbH’s COMIRNATY sBLA Documentation Review Memo 8/2/2022 1 BLA 125742/45: Documentation Review Memo Product Information: COMIRNATY Indication and Use: Active im munization to prevent coronavi rus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in in dividuals 12 years of age and older. Communications (IRs) from CBER: IR # Request Date CBER Rep(s) Request CBER Requester for…
125742 45 08 02 2022 Memo Committee Memo Label
1 LABELING REVIEW MEMORANDUM To: The File Date: August 2, 2022 STN: 125742/45 Supplement Type: Efficacy Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.) Product: COVID-19 Vaccine, mRNA (COMIRNATY) From: Laura Gottschalk, Ph.D. and CAPT Mike Smith, Ph.D. OVRR/DVRPA/RRB3 Through: Elizabeth M. Sutkowski, Ph.D. OVRR/DVRPA/RRB3 Summary: COMIRNATY was originally approved on August 23, 2021 (STN 125742/0) for active immunization to…
125742 45 S252 M5 summary differences csr vs update
Table 1: Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population ............................................ 2 090177e19939f70a\Final\Final On: 31-Jan-2022 15:29 (GMT) FDA-CBER-2022-5812-0235489 Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for…
125742 45 S267 M1 response 23feb2022
COVID-19 Vaccine (BNT162, PF -07302048) BLA STN 125742/45 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1COVID-19 Vaccine (BNT162, PF -07302048; COMIRNATY) BLA STN 125742/45 Response to CBER IR Regarding Cumulative Analysis of Post -Authorization Adverse Event Reports in Individuals Aged Between 12 and 15 Year of Age Received 23 February 2022 01March2022 090177e1997c34ec\Approved\Approved On: 01-Mar-2022 16:03 (GMT) FDA-CBER-2022-5812-0235491 COVID-19 Vaccine…
125742 45 S267 M5 sum post auth ae report exclude us
Page 1 of 36 As of Date: 01-OCT-2021 1.AER Number Case Seriousness: SERIOUS Seriousness Criteria: DeathSection Page: 1 Patient Demographic Sex Age Height (cm) Weight (kg) Race Country Where Event Occured FEMALE 14 YEARS NO DATA - NO DATA ROMANIA This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 14-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date…
125742 45 S267 M5 sum post auth ae report us
Page 1 of 11 As of Date: 01-OCT-2021 1.AER Number Case Seriousness: SERIOUS Seriousness Criteria: Death,Medically SignificantSection Page: 1 Patient Demographic Sex Age Height (cm) Weight (kg) Race Country Where Event Occured MALE 13 YEARS NO DATA - NO DATA UNITED STATES This is a spontaneous report from a non-contactable consumer (columnist). A 13-year-old male patient received second dose of BNT162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number…
125742 45 S271 M1 appendix 1 immunobridging data c4591001
Summary of Geometric Mean Titers, by Baseline SARS -CoV-2 Status – NT50 – Subjects 12 Through 15 a nd 16 Through 25 Years of Age (Immunogenicity Subset) – D ose 2 Eval uable Immunog enicity Population ............................................................................................................................................................................. 2 Summary of Geometric Mean Titers, by Baseline SARS -CoV-2 Status – NT50 – Subjects 12 Through 15 and 16 Through 25…
125742 45 S271 M1 appendix 2 track changes immunobridging data c4591001
Summary of Geometric Mean Titers, by Baseline SARS-CoV-2 Status – NT50 – Subjects 12 Through 15 and 16 Through 25 Years of Age (Immunogenicity Subset) – Dose 2 Evaluable I mmunogenicity Population .......... ........................................................................................................................................................... 2 Summary of Geometric Mean Titers, by Baseline SARS-CoV-2 Status – NT50 – Subjects 12 Through 15 and 16 Through 25 Years of Age …
125742 45 S271 M1 response 07mar2022
COVID-19 Vaccine (BNT162, PF -07302048) BLA STN 125742/45 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1 COVID-19 Vaccine (BNT162, PF -07302048; COMIRNATY) BLA STN 125742/45 Response to CBER Information Request of 07 March Regarding Immunobridging Data and Updated Safety Data for Adolescents 12 Through 15 Years of Age 11March 2022 090177e19995f282\Approved\Approved On: 11-Mar-2022 12:15 (GMT) FDA-CBER-2022-5812-0235605 COVID-19 Vaccine (BNT162, PF -07302048)…
125742 45 S273 M1 req comments advice sbla
COVID -19 Vaccine (BNT162, PF -07302048) BB-IND 19736 1.12.4 Request for Comments and Advice PFIZER CONFIDENTIAL Page 1COVID -19 Vaccine (BNT162, PF -07302048) Request for Comments and Advice sBLA Booster Dose for Children 12 Through 15 Years of A ge March 2022 090177e1999f163a\Approved\Approved On: 15-Mar-2022 14:40 (GMT) FDA-CBER-2022-5812-0235609 COVID -19 Vaccine (BNT162, PF -07302048) BB-IND 19736 1.12.4 Request for Comments and Advice PFIZER CONFIDENTIAL Page 21.INTRODUCTION Reference…
125742 45 S328 M1 lab 1490 1 2 pkg insert clean
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 --------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage (1) M/YYYY Dosage and Administration, Preparation for Administration (2.1) M/YYYY…
125742 45 S312 M1 lab 1448 2 1 annotated
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to u se COMIRNATY safely and effectively. See full prescribing informat ion for COMIRNATY. COMIRNATY® (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage (1) M/YYYY Dosage and Administration, Preparation for Administration (2 1) …
125742 45 S312 M1 lab 1448 2 1 pkg insert clean
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 --------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage (1) M/YYYY Dosage and Administration, Preparation for Administration (2.1) 12/2021…
125742 45 S314 M1 pharmacovigilance plan
BNT162b2 1.16 Risk Management Plan (Non -REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 1PHARMACOVIGILANCE PLAN FOR BIOLOGIC LICENSE APPLICATION #125742 OF COMIRNATY® ( PFIZER-BIONTECH COVID-19 VACCINE , mRNA, BNT162b2, PF-07302048 ) Date of Report: 29 April 2022 Version 1.4.1 090177e19a101be3\Approved\Approved On: 29-Apr-2022 19:59 (GMT) FDA-CBER-2022-5812-0235677 BNT162b2 1.16 Risk Management Plan (Non -REMS) for Biologic License Application # 125742 CONFIDENTIAL Page…
125742 45 S314 M1 pharmacovigilance plan track
BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 1 PHARMACOVIGILANCE PLAN FOR BIOLOGIC LICENSE APPLICATION #125742 OF COMIRNATY® ( PFIZER-BIONTECH COVID-19 VACCINE , mRNA, BNT162b2, PF-07302048 ) Date of Report: 14 December 202129 April 2022 Version 1.4.1 090177e19a14c996\Final\Final On: 29-Apr-2022 17:55 (GMT) FDA-CBER-2022-5812-0235809 BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License…
125742 45 S316 M1 response 22april2022
COMIRNATY (COVID -19 Vaccine, mRNA) BLA 125742 /45 M 1.11.3 Response to FDA Information Request CONFIDENTIAL Page 1COMIRNATY (COVID -19 VACCINE, mRNA) Response to CBER 22 April 2022 Information Request to Pfizer/BioNTech Regarding Study Protocol for Study C4591022 ( A Non- Interventional Post -Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/Mother To Baby Pregnancy Registry) 02 May 2022…
125742 45 S321 M1 response 04may2022
Pfizer-BioNTech COVID -19 Vaccine EUA 27034 M 1.11.3 Response to FDA Information Request Pfizer-BioNTech COVID -19 Vaccine Response to CBER04May2022 Information Request Regarding Package Insert Information for ReportedNauseain Placebo Recipients 12 -15 Years of Age 09May2022 090177e19a256afd\Approved\Approved On: 09-May-2022 08:22 (GMT) FDA-CBER-2022-5812-0235944 COVID-19 Vaccine (BNT162, PF -07302048) BB-IND 19736 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2LIST OF…
125742 45 S328 M1 lab 1448 2 2 annotated
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to u se COMIRNATY safely and effectively. See full prescribing informat ion for COMIRNATY. COMIRNATY® (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage (1) M/YYYY Dosage and Administration, Preparation for Administration (2 1) …
125742 45 S328 M1 lab 1448 2 2 pkg insert clean
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 --------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage (1) M/YYYY Dosage and Administration, Preparation for Administration (2.1) M/YYYY…