125742 S61 M1 response 17aug2021
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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 17 Aug 2021 FDA queries –Shelf -life and date of manufacture PFIZER CONFIDENTIAL Page 1QUERY 1 Please send information on what y our final, intended drug product shelf life will be and commit to submitting stability data in real time post licensure to support this requested shelf life. Response 1 The final commercial shelf life of the BNT162b2 drug product presently is inte nded to be 24 months when stored at the intended storage condition of - 90 to -60 °C. The Sponsor commits to submitting stability data to support extension of the drug product shelf life beyond the current request ed9-month period a t interval swhen supporting data are available . Depending on the resulting da ta, an approximate timetable would be: Target Expiry Extension Approximate supplement date 12Months February 2021 18 Months August 2022 24 Months February 2023 Each submission would contain a Module 2 2.3 Introduction a ndModule 3 documents (e.g 3.2.P.8.1, 3.2.P.8.3) Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation None Previously submitted supporting documentation None 090177e197d9f93c\Approved\Approved On: 19-Aug-2021 12:49 (GMT) FDA-CBER-2021-5683-1149924 COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 17 Aug 2021 FDA queries –Shelf -life and date of manufacture PFIZER CONFIDENTIAL Page 2QUERY 2 Please define your “date of manufacture” for the final, undiluted drug product. Response 2 The date of manufacture as defined b y the Pfizer Kalamazoo manufacturing site is the date of The date of manufacture as defined b y the Pfizer Puurs manufacturing site is the date ofthe Across both the Pfizer Kalamazoo and Pfiz er Puurs sites, the date of manufacture is no later than the date of Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation None Previously submitted supporting documentation None 090177e197d9f93c\Approved\Approved On: 19-Aug-2021 12:49 (GMT) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1149925