Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 17August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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 BLASTN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to 16 August2021 CBER Information Request Regarding Diluent Packaging Labels August 2021 090177e197d4ab2d\Approved\Approved On: 17-Aug-2021 13:48 (GMT) FDA-CBER-2021-5683-0950352 BNT162b2 BLASTN 125742/0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 2TABLE OF CONTENTS 1. INTRODUCTION ................................…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 18August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biologics Evaluation and Research DocumentControl 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…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 21August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 26August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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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Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 30 August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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 AN…
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FDA-CBER-2021 5683 0951285 Digitally signed by DN o=Pfizer Inc Reason I am signing on behalf of Donna Boyce Location Date 2021.09.01 10 0 05 0800' (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-0951286
Pfizer Documents (PHMPT/FDA)
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Product (Generic Name) Application Number ID Code Trumenba (Meningococcal Group B Vaccine) BLA 125549 PP-PNA -USA -4653 COMIRNATY (COVID -19 mRNA Vaccine (nucleoside modified) ) BLA 125742 PP-PNA -USA -4653 Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) BLA 125731 PP-PNA -USA -4653 FDA-CBER-2021-5683-0951287
Pfizer Documents (PHMPT/FDA)
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Revised: 23August 2021 1FACT SHEET FOR HEA LTHCA RE PROVIDERS A DMINISTERING VA CCINE (VACCINA TION PROVIDERS) EMERGENCY USE AUTHORIZA TION (EUA) OF THE PFIZER -BIONTECH COVID -19 VA CCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) The U.S. Food and Drug A dministration (FDA ) has issued an Emergency Use Authorization (EUA ) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID- 19 Vaccine , for active immunization to prevent COVID -19 in ind ividuals…
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1 Revised: 23August 2021VACCINE INFORMA TION FACT SHEET FOR REC IPIENTS AND CA REGIVERS ABOUT COMIRNA TY (COVID -19 VA CCINE, mRNA ) ANDPFIZER -BIONTECH COVID -19 VACCINE TO PREVENT CORONA VIRUS DISEA SE 2019 (COVID -19) You are being offered either COMIRNA TY (COVID -19 Vaccine, mRNA ) or the Pfizer-BioNTech COVID- 19 Vaccine to prevent Coronavirus Disease 2019 (COVID -19)caused by SARS-CoV-2. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for…
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1HIGHLIGHTS OF PRESCRI BING INFORMATION These highlights do not include all the information needed to use PREVNAR 13 safely and effectively. See full prescribing information for PREVNAR 13. PREVNAR 13 (Pneumococcal 13 -valent Conjugate Vaccine [Diphtheria CR M197Protein]) Suspension for intramuscular injection Initial USApproval: 2010 --------------------------- INDICATIONS AND USAG E-------------------------- In children 6 weeks through 5 years of age (prior to the 6thbirthday), Prevnar 13…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 20August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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 BLA STN 125742 /0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER 19 August 2021 Follow -up Information Request Regarding Postmarketing Commitment S tudy C4591014 20August 2021 090177e197dc8b8a\Approved\Approved On: 20-Aug-2021 12:21 (GMT) FDA-CBER-2021-5683-0950388 BNT162b2 BLA STN 125742 /0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 21.INTRODUCTION Reference is made to BLA STN…
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 20August2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research DocumentControl 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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Page 1 of 2 BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz Germany Tel.: +49 (0) 6131- 90 84 0 Fax: +49 ( 0) 6131- 90 84 390 [email protected] Managing Director : Dr. Sierk P oetting Dr. Oliver Hennig Martin Lang Jan Kürschner Commercial Register District court M ainz HRB 47548 VAT: DE 313150544 Tax ref. no: DE263241058695198 Deutsche Bank IBAN: DE94 5507 0040 00 70 1441 00 SWIFT: DEUTDE5MXXX Date: August 3, 2021 Ref: Letter of…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 20August 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 SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 20August 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 SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
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BNT162b2 BLA STN 125742 /0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1 BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER 20 August Information Request – Study C4591001 Frequency of Adverse Events by Age Group and Overall By Study Period in Blinded Follow -up 20 August 2021 090177e197dda203\Approved\Approved On: 20-Aug-2021 22:26 (GMT) FDA-CBER-2021-5683-0950399 BNT162b2 BLA STN 125742 /0 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page…
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August 23, 2021 RE: Pfizer-BioNTech COVID-19 Vaccine Now FDA Approved as COMIRNATY® IMPORTANT PRODUCT INFORMATIONCertain Pfizer-BioNTech COVID-19 Vaccine Lots authorized for Emergency Use comply with the Biologics License Application (BLA) Dear Healthcare Professional, Pfizer, Inc. would like to provide you with updated and very important information related to the Pfizer-BioNTech COVID-19 Vaccine, authorized for emergency use by FDA under an Emergency Use Authorization (EUA). On August 23,…
Pfizer Documents (PHMPT/FDA)
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Recommendation –Identification of BLA Lots Identifier Options 195 tray: Unable to apply sticker/signage on frozen trays. Note: Tray label contains QR code. Shipping Container: Able to include a leaflet on top inside for identified batches. Approach used with 25pack. Electronic via QR codes: Updates to HCP site (see next slide for details). Allows for updates to lot numbers as variations are approved in BLA. FDA-CBER-2021-5683-0951273 Document Approval Record Document Name: …