Pfizer Documents (PHMPT/FDA)
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PF-07302048 (BNT162b2 RNA -Based COVID -19 Vaccine) Protocol C4591020 Protocol, 18January2021 PFIZER CONFIDENTIAL CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 1 A PHASE 3, RANDOMIZE D, OBSERVER -BLIND ST UDY TO EVALUATE THE SAFETY, TOLERABILITY , AND IMMUNOGENICITY OF A LYOPHILIZED FORMULATION OFTHE VACCINE CANDIDA TEBNT162b2 AGAINST COVID-19 INHEALTHY ADULTS 18 T HROUGH 55 YEARS OF A GE Study Sponsor: BioNTech Study Conducted By: Pfizer Study Intervention Number:…
Pfizer Documents (PHMPT/FDA)
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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…
Pfizer Documents (PHMPT/FDA)
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· 40 pages
Page 1 of 40Statistical analy sis plan Avon Community Acquired Pneumonia Study (Avon CAP): A Pan- pandemic Acute Lower Respiratory Tract Disease Surveillance Study Sponsor Project Reference Number 2020 -2991 ISRCTN registry number IRAS ID Number 283899 REC Number 20/EE/0157 Pfizer reference number WI255886 -1 090177e1969c5f96\Approved\Approved On: 24-Mar-2021 17:28 (GMT) FDA-CBER-2021-5683-1073634 Page 2 of 40Contents CHAPTER 1 –Study introduction and conduct…
Pfizer Documents (PHMPT/FDA)
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Listing 7.7.6 Page 3of 4 BNT162b2 Protocol C4591008 Participant Reported Unplanned Hospitalization PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP, HO, CE Generated from /dcri/ct/hero_together/lists/l_hosp.sas on 24MAY2021 12:45 Page 1614 of 1689 Subject ID Age/Sex/Race Vaccination Date Admission DateDays Hospitalized Condition(s) Causing hospitalization C4591008 -1306785856 35/F/NOT REPORTED2020 -12-23 2021 -01-25 4 COVID -19…
Pfizer Documents (PHMPT/FDA)
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Appendix 7 List of Subject Data Listings 090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) Page 1 FDA-CBER-2021-5683-1075881 TABLE OF CONTENTS Listing 7.7.1 -Withdrawn Subjects ................................................................................................................................................................................................... 1 Listing 7.7.2 -Participant Reported Death…
Pfizer Documents (PHMPT/FDA)
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TELECONFERENCE SUMMARY Application number: BLA STN 125742/0 Product name: COVID -19 Vaccine, mRNA (COMIRNATY) Proposed Indication: Active immunization to prevent COVID -19 caused by SARS-CoV -2 in individuals 16 years of age and older Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.) Teleconference date & time: August 16 , 2021; 4:00 PM - 4: 16 PM EDT FDA Participants: Maryna Eichelberger , Ph.D. Mary Malarkey Ramachandra Naik , Ph.D. …
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra <[email protected]> Sent: Monday, August 16, 2021 5:26 PM To: Harkins Tull, Elisa <[email protected]> Cc: Gottschalk, Laura <[email protected]>; Smith, Michael (CBER) <[email protected]>; Rohlfing, Paul <[email protected]>; Aghajani Memar, Neda <[email protected]>; Boyce, Donna <[email protected]> Subject: STN 125742/0 – COMIRNATY – Submission of CMC information to support extension of shelf…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Monday, August 16, 2021 10:38 AM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Subject: STN 1 25742.0: IR RE diluent suppliers Elisa, The review team has the below information request for…
Pfizer Documents (PHMPT/FDA)
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· 4 pages
We have the following requests and instructions regarding test methods, the lot release process, and the lot release protocol template: A. Regarding the RNA integrity assay by CGE: Please explain how the If available, provide the work instructions for CGE or commit t o generating these instructions. B. Regarding lot release of the 7 EUA lots: 1. Please send samples (20 vials) of each lot to the address noted below as soon as possible. We can receive them any day and prefer…
Pfizer Documents (PHMPT/FDA)
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· 4 pages
We have the following requests and instructions regarding test methods, the lot release process, and the lot release protocol template: A. Regarding the RNA integrity assay by CGE: Please explain how the If available, provide the work instructions for CGE or commit t o generating these instructions. B. Regarding lot release of the 7 EUA lots: 1. Please send samples (20 vials) of each lot to the address noted below as soon as possible. We can receive them any day and prefer…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Smith, Michael (CBER) Sent: Friday, August 13, 2021 12:32 PM To: Aghajani Memar, Neda <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742.0: Requests and instructions regarding test methods, the lot release process, and the lot…
Pfizer Documents (PHMPT/FDA)
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· 3 pages
From: Smith, Michael (CBER) Sent: Friday, August 13, 2021 3:36 PM To: Aghajani Memar, Neda <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742.0: 7 facility questions from the DMPQ team Neda and Paul, The DMPQ review team has the…
Pfizer Documents (PHMPT/FDA)
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From: Zubkova, Iryna Sent: Friday, August 13, 2021 5:46 PM To: DeCiero, Daniel Cc: Peters, Lori; Zubkova, Iryna; Naik, Ramachandra; Smith, Michael (CBER); Gottschalk, Laura; Ertel, Donald Subject: Request for Compliance Check BLA STN 125742/0 Importance: High Hello Daniel ! Please execute the Compliance Check for BLA 125742/0. The PD UFA ADD is January 16, 2022. But the internal ADD is August 20, 2021 or August 27, 2021. Facilities table has been updated and…
Pfizer Documents (PHMPT/FDA)
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www.fda.gov DATE: August 13, 2021 FROM : Haecin Chun, MS, Bioresearch Monitoring Branch (BMB) Division of Inspections and Surveillance (DIS) Office of Compliance and Biologics Quality (OCBQ) THROUGH: Dennis Cato , Chief BMB THROUGH: Carrie Mampilly, MPH, Director DIS THROUGH: Mary A. Malarkey, Director OCBQ TO : Ramachandra Naik, PhD , Chair Susan Wollersheim, MD , Clinical Reviewer CAPT Ann Schwartz, MD, Clinical Reviewer CAPT Michael…
Pfizer Documents (PHMPT/FDA)
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CMC Review Memorandum Date: August 12, 2021 To: The File From : Anissa Cheung, DVP , Product Specialist Through: Jerry Weir, DVP CC: Ramachandra Naik , DVRPA , Chair ; Michael Smith , DVRPA, RPM ; Laura Gottschalk , DVRPA, RPM ; Kathleen Jones , DMPQ, Lead Inspector Applicant n ame: Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC. STN : STN 125742/0 Amendment #25 COVID-19 mRNA Vaccine (BNT162/PF-07302048) Subject: Original BLA submission …
Pfizer Documents (PHMPT/FDA)
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TELECONFERENCE SUMMARY Application number: BLA STN 125742/0 Product name: COVID -19 Vaccine, mRNA (COMIRNATY) Proposed Indication: Active immunization to prevent COVID -19 caused by SARS- CoV-2 in individuals 16 years of age and older Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.) Teleconference date & time: August 11, 2021; 12: 00 PM - 12:39 PM EDT FDA Participants: Anissa Cheung, Ph.D. Maryna Eichelberger , Ph.D. John Eltermann,…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Wednesday, August 11, 2021 10:27 AM To: Aghajani Memar, Neda <[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: Diluent IR Neda, The review team has the below question regarding the diluent that is to be provided in the BLA. They have…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Smith, Michael (CBER) Sent: Tuesday, August 10, 2021 1:11 PM To: 'Aghajani Memar, Neda' <[email protected]>; 'Harkins Tull, Elisa' <[email protected]>; 'Devlin, Carmel M' <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected] ov> Subject: STN 125742.0: Testing related IR Neda, The review team has the below testing related IR and they have requested a response by Wednesday,…
Pfizer Documents (PHMPT/FDA)
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· 5 pages
From: Naik, Ramachandra < [email protected] > Sent: Monday, August 9, 2021 9:03 AM To: Rohlfing, Paul < [email protected]>; Smith, Michael (CBER) < [email protected] >; Harkins Tull, Elisa <[email protected] >; Aghajani Memar, Neda <[email protected] >; Devlin, Carmel M < [email protected] > Cc: Gottschalk, Laura < [email protected] > Subject: RE: STN 125742.0: Questions regarding valida tion of assay methods and lot…
Pfizer Documents (PHMPT/FDA)
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Inspection Waiver -STN 125742/0 Page 1 of 5 _____________________________________________________________________________________________ Food and Drug Administration Center for Biologics Evaluation and Research Division of Manufacturing and Product Quality From: Kathleen R. Jones , CMC / Facility Reviewer, OCBQ/DMPQ/MRB1 Laura Fontan, CMC / Facility Reviewer, OCBQ/DMPQ/MRB1 …