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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From: Smith, Michael (CBER) Sent: Wednesday, August 4, 2021 5:27 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: RE: [EXTERNAL] STN 125742.0: Comments on LRP template submitted to STN 125742/0.14 on 7/20 Elisa, I…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Tuesday, August 3, 2021 6:08 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: Clinical/stats IR Elisa, The review team has two clinical/stats questions and they requested a response by Friday, August 6,…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Monday, August 2, 2021 4:40 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: Questions regarding the Validation Report VR -MVR -10077 Elisa, The review team has the below set of questions for Pfizer regarding…
Pfizer Documents (PHMPT/FDA)
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From: Gottschalk, Laura Sent: Thursday, July 29, 2021 6:22 PM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]> Subject: STN 125742/0 – COMIRNATY (COVID -19 Vaccine, mR NA) – Comment regarding analyses for safety for the two age groups Dear Ms. Harkins: Our review of…
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra <[email protected]> Sent: Wednesday, July 28, 2021 2:16 PM To: Harkins Tull, Elisa <[email protected]> Cc: Gottschalk, Laura <[email protected]>; Smith, Michael (CBER) <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742/0 - COMIRNATY (COVID -19 Vaccine, mR NA) - Preliminary comments on Package Insert Dear Ms. Harkins, …
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra Sent: Wednesday, July 28, 2021 4:37 PM To: Harkins Tull, Elisa < [email protected] > Cc: Gottschalk, Laura < [email protected] >; Smith, Michael (CBER) <[email protected] >; Aghajani Memar, Neda < [email protected] >; Devlin, Carmel M <[email protected] > Subject: STN 125742/0 - COMIRNATY (COVID -19 Vaccine, mRNA) – CBER comments regarding postmarketing safety study(ies) Dear Ms. Har kins, Our review…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Tuesday, July 27, 2021 10:44 AM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: RE: [EXTERNAL] RE: STN 125742.0: IR RE assessment of vaccine effectiveness Elisa, Sorry, but the below question was inadvertently omitted from the…
Pfizer Documents (PHMPT/FDA)
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From: Gottschalk, Laura Sent: Monday, July 26, 2021 2:06 PM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]> Subject: STN 125742/0: IR RE disposition of participant s in safety populations who experienced pregnancy Dear Ms. Harkins, The review team has comments for…
Pfizer Documents (PHMPT/FDA)
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From: Gottschalk, Laura Sent: Thursday, July 22, 2021 8:52 PM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]> Subject: STN 125742/0: IR regarding clinical shell tables for study C4591001 Dear Ms. Harkins, Reference is made to your original BLA STN 125742/0. Attached,…
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra Sent: Tuesday, July 20, 2021 5:41 PM To: Harkins Tull, Elisa < [email protected] > Cc: Gottschalk, Laura < [email protected] >; Smith, Michael (CBER) <[email protected] >; Aghajani Memar, Neda < [email protected] >; Devlin, Carmel M <[email protected] > Subject: STN 125742/0 - COMIRNATY BLA – Pediatric PMR studies Dear Ms. Harkins, Currently, you are proposing a deferred study C4 591007 to evaluate the…
Pfizer Documents (PHMPT/FDA)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH OFFICE OF VACCINES RESEARCH AND REVIEW DIVISION OF VACCINES AND RELATED PRODUCTS APPLICATIONS DATE: July 22, 2021 PAGES: 17 TO: BioNTech RNA Pharmaceuticals GmbH/Pfizer. Inc. Attention: Elisa Harkins 500 Arcola Road Collegeville, PA 19426 Phone: 215- 280-5503 Fax number: 845- 474-3500 E-mail: …
Pfizer Documents (PHMPT/FDA)
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Data Fitness Findings Report IND27034 BioNTech SE and Pfizer , April 2021 Findings Notes C4591001 EUA Amendment (12 -15 Years of Age) Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID - 19 in Healthy Individuals. Document / Standard Version Notes annotated CRF Seems fine SDTM Implementation Guide SDTM -IG v3.2 SDTM Controlled Terminology 2020-03-27 SDTM define.xml V2.0 Seems…
Pfizer Documents (PHMPT/FDA)
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BLA 125742/EU A 27034 D ata validation Report Summary and Subsequent follow -up with Pfizer Our Reference: BLA 125742/E UA 27034 (studied under IND 19736) Sponsor: Pfizer -BioNTech SE Product: COVID- 19 (BNT162b2) Proposed Indication: Prevention of COVID- 19 in individuals 16 years of age and older. On May 7, 2021 the BLA was submitted and included datasets for C4591001 and BNT162- 01. However, prior to this time we had also received part of the…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Thursday, July 15, 2021 1:47 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: IR RE Study C4591007 Elisa, The review team has the question below for you regarding Study C4591007. The review team has…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Thursday, July 15, 2021 4:09 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: RE: [EXTERNAL] RE: STN 125742.0: IR RE the Pharmacovigilance Plan Elisa, The review team provided me with the below response regarding the request…
Pfizer Documents (PHMPT/FDA)
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1 JULY MONTHLY MEETING SUMMARY Application number: BLA STN 125742/0 Product name: COVID- 19 mRNA Vaccine (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 Meeting date & time: July 15 , 2021; 3:30 - 5:00 PM EDT Committee Chair: Ramachandra Naik, Ph.D. Meeting Recorder s: CAPT Michael Smith, Ph.D. and Laura Gottschalk, Ph.D. …
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Tuesday, July 13, 2021 3:31 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: IR RE the Pharmacovigilance Plan Elisa, The review team has the below Information Request regarding the Pharmacovigilance Plan…
Pfizer Documents (PHMPT/FDA)
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· 7 pages
08/20/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 500 Arcola Road Collegeville PA 19426215-280-5503 845-474-3500 [email protected] 125742 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to…
Pfizer Documents (PHMPT/FDA)
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· 7 pages
08/23/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Amit Patel, Director, Pfizer Global Regulatory Affairs - Vaccines 235 East 42nd Street New York NY 10017214-918-5262 845-474-3500 Amitkumar.Patel@pfizer 125742 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused…