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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742.0 Response to 06 Aug 2021 FDA 3 Questions on Measurement of Endotoxin Procedures PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS QUERY 1 ................................ ................................ ................................ ................................ ...2 QUERY 2 ................................ ................................ ................................ ................................ ...4 QUERY 3…
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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 17Aug 2021 FDA queries –Drug Substance PFIZER CONFIDENTIAL Page 1QUERY 1 In your drug substance (DS) manufacturing process validation studies performed at both Pfizer and Pfizer the process parameter for the was validated to be within the range of . However, in y our documents Section 3.2.S.2.2 Manufacturing Process Andover and Section 3.2.S.2.4 Controls of Critical Steps and Intermediates -Manufacturing Process, the …
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 19August 202 1 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING …
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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 11Aug 2021 FDA IR1 –Diluent PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 QUERY 1 ................................ ................................ ................................ ................................ ...2 QUERY 1 -A................................ ................................…
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 13August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR…
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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 10 Aug 2021 FDA IR – Testing Related PFIZER CONFIDENTIAL Page 1QUERY 1 Please provide the established and poly dispersity index limits for the control lot of PF -07302048 -DP-RM for the test of “Size and poly dispersity Index Measurement in mRNA LNP Samples b y Dynam ic Light Scattering” for drug product. RESPONSE 1 Table 1provides the established and maximum poly dispers ity index (PDI) for control lot PF -07302048…
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 11 Aug ust2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR…
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BNT162b2 3.2.P.3.1. Manufacturer(s) PFIZER CONFIDENTIAL Page 13.2.P.3.1. MANUFACTURER(S) Table 3.2.P.3.1-1 lists the sites that have responsibilities in the production of BNT162b2 drug product and their specified functions. Table 3.2.P.3.1 -1. Sites and Responsibilities for BNT 162b2 Drug Product Manufacture Site FEI / DUNS Numbers Responsibility Pharm acia & Upjohn Company LLCc 7000 Portage Road Kalamazoo, MI 49001 United StatesFEI: 1810189 DUNS: 618054084LNP production and bulk drug …
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COVID -19 Vaccine (BNT162, PF -0730 2048) BLA 125742/0 Response to 05 Aug 2021 FDA IR-Facilities Questions PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 (PFIZER CHESTERFIELD ) ................................ ...................... 3 QUERY 1 ................................ ................................ ................................…
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 11August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
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Page 1 of 1Food and Drug Administration Reason for Submission Center for Biologics Evaluation and Research For Release Sample Custodian For Surveillance 10903 New Hampshire Avenue For Licensing Action* WO75 -G707 STN: ______________ Silver Spring, MD 20993 -0002 For Corrected Letter Date : Subject: Electronic Protocol Signature Page License No.: 0000 Company Name:____________________ [COMPANY NAME] hereb y submits the following lot as an electronic submission by Electronic…
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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 04Aug 2021 FDA IR–Lot Release Protocol (LRP) Template PFIZER CONFIDENTIAL Page 1The review team has the below comments on the lot release protocol (LRP) template that was submitted to BL A 125742/0.14 on July 20, 2021. QUERY 1 Throughout document Please correct the cc: line to STN 125742 -0/2229/FC Page 1 of 6 Please replace with the attached example (Attachment 1 – Electronic Protocol Page 1) Please make sure that the…
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 11August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
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COVID -19 Vacc ine (BNT162, PF -07302048) BLA 125742/0 Response to 06Aug 2021 FDA IR Regarding two drug product (DP) documents PFIZER CONFIDENTIAL Page 1QUERY 1 We note the following statement quoted below in your document 3.2.P.2 Manufacturing Process Development –Process Development and Characterization on page 47: “For more efficient processing, the software at Pfizer Puurs was updated to introduce a step, independent of the selected batch size, ” This step was validated in coupled…
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 10Aug 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 05 Aug 2021 FDA IR – Diluent PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 QUERY 1 ................................ ................................ ................................ ................................ ...2 RESPONSE 1 ................................ ................................…
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 09August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 02 Aug 2021 FDA IR–Assay Methods and Lot release PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS QUERY 1 ................................ ................................ ................................ ................................ ...2 RESPONSE 1 ................................ ................................ ................................ ................... 2 QUERY 2 ................................…
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 09 Aug 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR…
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COVID-19 Vaccine (BNT162, PF -07302048) BLA125742/0 Response to 04 Aug 2021FDA IR –Regarding potency assay for determination of IVE by flow cytometry PFIZER CONFIDENTIAL Page 1INTRODUCTION The review team has two questions for y ou regarding the potency assay for determination of in vitro expression (I VE) by flow cytometry . The review team has requested a response b y Friday, August 6, 2021. The following comments pertain to the Report for Co -validation of Test Method TM100010380…