Pfizer Documents (PHMPT/FDA)
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125742/45 Data validation Report Summary and Subsequent follow-up with Pfizer Our Reference: STN 125742/45 (studied under IND 19736/EUA 27034) Sponsor: Pfizer-BioNTech SE Product: COVID-19 (BNT162b2) Proposed Indication: Prevention of COVID-19 in individuals 12 through 15 years of age On December 16, 2021, the sBLA was submitted and included datasets for C4591001. x C4591001 - Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine…
Pfizer Documents (PHMPT/FDA)
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From: Gottschalk, Laura <[email protected]> Sent: Wednesday, April 20, 2022 5:35 PM To:Collins, Kathleen Mary Catherin e Cc:Mineo, Gosia ; Harkins Tu ll, Elisa <[email protected]>; Devlin, Carmel M <[email protected]>; Naik, Rama chandra <[email protected]>; Smith, Michael (CBER) <Michael.Smith2@fd a.hhs.gov>; MaguireThon, Meghan <[email protected]> Subject: STN 125742/45 - COMIRNATY sBLA - First set of PI labeling comments Importance:…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Wednesday, April 20, 2022 10:45 AM To:Collins, Kathleen Mary Catherin e Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Mineo, Gosia ; Harkins Tull, Elisa <[email protected]>; Devlin , Carmel M <[email protected]> Subject: STN 125742/45: IR RE PVP Kate, The review team has the below information request regarding the Pharmacovigilance Plan (PVP) that was submitted to STN 125742.45. In…
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra <[email protected]> Sent: Friday, April 8, 2022 10:50 AM To:Mineo, Gosia Cc:Harkins Tull, Elisa <Elisa.HarkinsTull@pfize r.com>; Collins, Kathleen Mary Catherine ; Devlin, Carmel M <C [email protected]>; Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura <[email protected]>; MaguireThon, Meghan <[email protected]> Subject: STN 125742/45 - Comirnaty sBLA to to extend the indication to ad olescents 12…
Pfizer Documents (PHMPT/FDA)
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Mid-Cycle Meeting Summary Application type and number: sBLA STN 125742/45 Product name: COVID-19 Vaccine, mRNA (COMIRNATY) Proposed Indication: Active immunization to prevent coronavirus disease 19 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older Applicant: BioNTech Manufacturing GmbH Meeting date & time: April 7, 2022; 11:00 AM – 12:30 PM EDT Committee Chair: Ramachandra Naik,…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Monday, March 14, 2022 9:17 AM To:Collins, Kathleen Mary Catherin e Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Mineo, Gosia Harkins Tull, Elisa <[email protected]>; Devlin , Carmel M <[email protected]> Subject: STN 125742/45 – Comirnaty sBLA – F/U Clinical-statistical question to Pfizer's response to our 3/7 comments regarding updated immunobridging analyses and solicited…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) < [email protected] > Sent: Tuesday, March 8, 2022 3:38 PM To: Collins, Kathleen Mary Catherine Cc: Naik, Ramachandra < Ram [email protected] >; Gottschalk, Laura <[email protected] >; Mineo, Gosia Harkins Tull, Elisa <[email protected] >; Devlin, Carmel M < [email protected] > Subject: RE: [EXTERNAL] RE: STN 125742/45 – Comirnaty sB LA – Clinical-statistic al comments regarding updated immunobridging analyses…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Monday, March 7, 2022 4:09 PM To: Collins, Kathleen Mary Catherine Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Mineo, Gosia Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742/45 – Comirnaty sBLA – Clinical-statistical comments regarding updated immunobridging analyses and solicited adverse reaction frequencies Dear Ms.…
Pfizer Documents (PHMPT/FDA)
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· 5 pages
1 MARCH MONTHLY MEETING SUMMARY Application number: BLA STN 125742/45 Product name: COVID-19 Vaccine, mRNA (COMIRNATY) Proposed Indication: Active immunization to prevent coronavirus disease 19 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older Applicant: BioNTech Manufacturing GmbH Meeting date & time: March 2, 2022; 1:00 - 2:00 PM EST Committee Chair: Ramachandra Naik, Ph.D. Meeting Recorders: CAPT Michael Smith, Ph.D.…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) Sent: Wednesday, February 23, 2022 3:06 PM To: Collins, Kathleen Mary Catherine Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Mineo, Gosia Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]> Subject: STN 125742.45: IR RE Cumulative Analysis of Po st-Authorization Adverse Event Reports in Individuals Aged Between 12 and 15 Year of Age Kate, We are…
Pfizer Documents (PHMPT/FDA)
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· 3 pages
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Pfizer Documents (PHMPT/FDA)
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From:Zhang, Jianmin (Jack) <[email protected]> Sent:Wednesday, January 5, 2022 2:06 PM To:Gottschalk, Laura <[email protected]>; Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]> Cc:Hussong, Virginia <[email protected]>; Lin, Lisa <[email protected]>; LopezMitnik, Gabriela <[email protected]> Subject:The validation results for BLA125742\45 supplement attached Importance: High Dear Laura, Ram and…
Pfizer Documents (PHMPT/FDA)
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· 17 pages
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Pfizer Documents (PHMPT/FDA)
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· 6 pages
1 FILING MEETING SUMMARY Application number: BLA STN 125742/45 Product name: COVID-19 Vaccine, mRNA (COMIRNATY) Proposed Indication: Active immunization to prevent coronavirus disease 19 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older Applicant: BioNTech Manufacturing GmbH Meeting date & time: January 31, 2022; 12:00 - 1:00 PM EST Committee Chair: Ramachandra Naik, Ph.D. Meeting Recorders: CAPT Michael Smith, Ph.D. and…
Pfizer Documents (PHMPT/FDA)
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From: Smith, Michael (CBER) < [email protected] > Sent: Tuesday, January 25, 2022 11:34 AM To:Collins, Kathleen Mary Catherine ; Harkins Tull, Elisa <Elisa.HarkinsTull@pfizer .com >; Devlin, Carmel M <[email protected] >; Mineo, Gosia Cc:Naik, Ramachandra < [email protected] >; Gottschalk, Laura <[email protected] > Subject: [EXTERNAL] STN 125742/45: IR RE EA/CE and FDA form 356 Kate, The review team has the below Information Requests (IRs) for you.…
Pfizer Documents (PHMPT/FDA)
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· 3 pages
From: Smith, Michael (CBER) Sent: Wednesday, January 19, 2022 5:30 PM To: Mineo, Gosia Cc: Collins, Kathleen Mary Catherine ; Naik, Ramachandra <[email protected]>; Gottschalk, Laur a <[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M <[email protected]>; Stafford, Adrienne Kaye <[email protected]> Subject: RE: [EXTERNAL] STN 125742/45: IR RE the datasets for adolescents 12 through 15 Years of Age …
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra Sent: Thursday, January 6, 2022 7:17 AM To: Smith, Michael (CBER) < [email protected] >; Gottschalk, Laura <[email protected] >; Sutkowski, Elizabeth M. < [email protected] >; Wollersheim, Susan < [email protected] >; Lee, Lucia < [email protected] >; Allende, Maria < [email protected] >; Wang, Xiao < [email protected] >; Cheung, Anissa <[email protected] >; Peden, Keith <…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Our STN: BL 125742/45 ACKNOWLEDGEMENT PRIOR APPROVAL SUPPLEMENT BioNTech Manufacturing GmbH Attention: Amit Patel January , 2022 Pfizer Inc. 235 East 42nd Street New York, NY 10017 Dear Mr. Patel:Please refer to your supplement to your Bi ologics License Application (BLA) submitted under section 351(a) of the Public Health Se rvice Act (PHS Act) for COVID-19 Vaccine, mRNA (COMIRNATY). Reason…
Pfizer Documents (PHMPT/FDA)
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sBLA BNT162b2 1.3.4 Financial Certificatio nand Disclosure PFIZER CONFIDENTIAL Page 1 1.3.4 FINANCIAL CERTIFICATION AND DISCLOSURE – BIAS STATEMENT Protocol Number: C4591001 Study Title: A Phase 1/2/3, Placebo -Controlled, Randomized, Observer -Blind, Dose - Finding Study To Evaluate The Safety, Tolerability, Immunogenicity, And Efficacy Of SARS -COV -2 RNA Vaccine Candidates Against COVID -19 In Healthy Individuals STEPS TAKEN TO MINIMIZE THE …
Pfizer Documents (PHMPT/FDA)
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· 10 pages
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