Pfizer Documents (PHMPT/FDA)

85 Courtesy Copy BLA 125742 0 Statistical Review COMIRNATY

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 11 pages

Statistical Review STN: 125742/0 Page i Application Type Original BLA STN 12574 2/0 CBER Received Date May 18, 2021 PDUFA Goal Date January 16, 2022 Division / Office OVRR Committee Chair Ramachandra Naik Product Reviewer Xiao Wang Project Manager Mike Smith and Laura Gottschalk Priority Review Yes Reviewer Name Xinyu Tang Review Completion Date / Stamped Date Concurrence Lei Huang, Concurring Reviewer , VEB, DB, OBE Tsai-Lien Lin, Branch…

84 BLA 125742 0 08 18 2021 Memo Committee Memo Review

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 MEMORANDUM Date: August 18, 2021 From: Marie J. Anderson, MS, PhD Division of Biological Standards and Quality Control (DBSQC) Office of Compliance and Biologics Quality (OCBQ) Center for Biologics Evaluation and Research (CBER) Food and Drug Administration (FDA) To: Biologics License Application Submission Tracking Number 125742 Subject: Review of Lot…

83 BLA 125742 0 08 17 2021 Telecon Other

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 4 pages

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 17 , 2021; 9:00 AM - 9:41 AM PM EDT FDA Participants: Ekaterina Allen Anissa Cheung, Ph.D. John Eltermann, R.Ph.,…

81 1 BLA 125742 0 08 17 2021 Telecon Information Reques

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

From: Smith, Michael (CBER) Sent: Tuesday, August 17, 2021 2:13 PM 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 on DS Elisa, The review team has the below questions on the drug substance and they…

79 3 BLA 125742 0 08 17 2021 Telecon Information Reques

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

From: Smith, Michael (CBER) Sent: Tuesday, August 17, 2021 6:47 PM 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]> Subject: STN 125742.0: IR RE shelf life and date of manuf acture Elisa, The review team has two questions regarding shelf life and date of manufacture. …

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 28 pages

FDA-CBER-2021-5683-1072574 FDA-CBER-2021-5683-1072575 FDA-CBER-2021-5683-1072576 FDA-CBER-2021-5683-1072577 FDA-CBER-2021-5683-1072578 FDA-CBER-2021-5683-1072579 FDA-CBER-2021-5683-1072580 FDA-CBER-2021-5683-1072581 FDA-CBER-2021-5683-1072582 FDA-CBER-2021-5683-1072583 FDA-CBER-2021-5683-1072584 FDA-CBER-2021-5683-1072585 FDA-CBER-2021-5683-1072586 FDA-CBER-2021-5683-1072587 FDA-CBER-2021-5683-1072588 FDA-CBER-2021-5683-1072589 FDA-CBER-2021-5683-1072590 FDA-CBER-2021-5683-1072591…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 11 pages

FDA-CBER-2021-5683-1072366 PF-07302048 : SARS -CoV- 2 Whole Genome Sequencing Data Collection and A nalysis Guidelines VR-VTN -10436 , Ver. 1.0 PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 LIST OF FIGURES ................................ ................................ ................................ ................... 2 1. BACKGROUND…