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Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 10August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Biolo gics 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…
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Non-Interventional Study Report Abstract Protocol C4591008 PFIZER CONFIDENTIAL Page 1NON- INTERVENTIONAL STUDY REPORT ABSTRACT Title: A Post-Emergency Use Authorization Observational C ohort S tudy to Evaluate the Safety of the Pfizer -BioNTech COVID-19 Vaccine in US Healthcare Workers, T heir Families, and Their Communities Date: 22June 2 021 Name and affiliation of the main author: Emily O’Brien, PhD Duke Clinical Research Institute 200 Morris Street Durham, NC 27701 Keywords: COVID…
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BNT162b2 (COVID -19 vaccine) C4591012 NON-INTERVENTIONAL STUDY PROTOCOL Final Version 12.0, 27 January 31 Aug 2021 PFIZER CONFIDENTIAL Page 1 of 237 NON -INTERVENTIONAL (NI) STUDY CONCEPT PROTOCOL Title Post-Emergency Use Authorization Active Safety Surveillance Study among Individuals in the Veteran’s Affairs Health System Receiving Pfizer -BioNTech Coronavirus Disease 2019 (COVID -19) Vaccine Protocol number C4591012 Protocol version identifier Final Version…
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Non-Interventional Study Interim Report Abstract Protocol C4591012 22June 2021 PFIZER CONFIDENTIAL Page 1of 9NON- INTERVENTIONAL STUDY INTERIM REPORT ABSTRACT Title :Post-Emergency Use Authorization Active Safety Surveillance Study among Individuals in the Veteran ’s Affairs Health S ystem Receiving Pfizer -BioNTech Coronavirus Disease 2019 (COVID -19) Vaccine Date: 22June 2021 Name sand affiliation sof the main authors : Yinong Young Xu, ScD, MA, MS , Veterans Affairs Medical Center ,…
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Pharmaceutical Pathobiology–Original Article Safety Evaluation of Lipid Nanoparticle– Formulated Modified mRNA in the Sprague- Dawley Rat and Cynomolgus Monkey Maja Sedic1, Joseph J. Senn1, Andy Lynn1, Michael Laska1, Mike Smith1, Stefan J. Platz2, Joseph Bolen3, Stephen Hoge1, Alex Bulychev1, Eric Jacquinet1, Victoria Bartlett4, and Peter F. Smith5 Abstract The pharmacology, pharmacokinetics, and safety of modified mRNA formulated in lipid nanoparticles (LNPs) were evaluated afterrepeat…
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BNT162b2 C4591014 NON- INTERVENTIONAL STUDY PROTOCOL Version 1.0, 22March 2021 PFIZER CONFIDENTIAL CT24- WI-GL02 -RF02 2.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 15-Aug-2018 Page 1 of 42NON -INTER VENTIONAL (NI) STUDY PROT OCOL This document contains confidential information belonging to Pfizer. Except as otherw ise agreed to in w rit- ing, by accepting or reviewing this document, you agree to hold this information in confidence and not copy or …
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090177e194a3e5e4\Approved\Approved On: 29-Sep-2020 03:51 (GMT) Page 1 FDA-CBER-2021-5683-1072171 090177e194a3e5e5\Approved\Approved On: 29-Sep-2020 03:51 (GMT) Page 2 FDA-CBER-2021-5683-1072172 1 Project Sponsor Flags Technical 26 -MAY-20 02:26…
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090177e19684b473\Approved\Approved On: 15-Mar-2021 12:52 (GMT) (b) (6) (b) (6) (b) (6) (b) (6) FDA-CBER-2021-5683-1147649
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Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 31March 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…
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SARS -CoV- 2 mRNA Vaccine (BNT162, PF -07302048) BB-IND 19736 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1SARS -CoV -2 mRNA VACCINE (BNT162, PF -07302048) BB-IND 19736 Response to CBER Request for Information Received on 29 July 2020 – Questions Regarding Clinical Assay Qualification 21August 2020 090177e194b449b7\Approved\Approved On: 20-Aug-2020 13:42 (GMT) FDA-CBER-2021-5683-1072455 SARS -CoV- 2 mRNA Vaccine (BNT162, PF -07302048) BB-IND 19736 M 1.11.3 Response to…
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COVID -19 Vaccine (BNT162, PF -07302048) BB-IND 19736 M 1.11.3 Response to FDA Information Request PFIZER CONFIDENTIAL Page 1COVID -19 Vaccine (BNT162, PF -07302048) IND 19736 Response to 30 June 2021 Information Request Regarding Updating Informed Consent Documents and Investigator's Brochure with I nformation R elated to Myocarditis and Pericarditis July 2021 090177e1977bc90c\Approved\Approved On: 05-Jul-2021 23:14 (GMT) FDA-CBER-2021-5683-1072511 COVID -19 Vaccine (BNT162, PF -07302048)…
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PF-07302048 Validation Protocol fo r the SARS- CoV-2 mNeonG reen Virus Microneutralization Assay VR-MVP -10074, Ver. 2.0 PFIZER CONF IDENTIAL Page 1 Title: Validation Protocol for the SARS -CoV -2 mNeonGreen Virus Microneutralization Assay Study Number: N/A Parent Compound Number(s): PF-07302048 Alternative Compound Identifiers: N/A Pfizer Vaccine Research and Development 401 N. Middletown Rd. Pearl River, NY 090177e195a9b590\Approved\Approved On: 02-Dec-2020 14:18 (GMT)…
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FDA-CBER-2021-5683-1072546 FDA-CBER-2021-5683-1072547 FDA-CBER-2021-5683-1072548 FDA-CBER-2021-5683-1072549 FDA-CBER-2021-5683-1072550 FDA-CBER-2021-5683-1072551 FDA-CBER-2021-5683-1072552 FDA-CBER-2021-5683-1072553 FDA-CBER-2021-5683-1072554 FDA-CBER-2021-5683-1072555 FDA-CBER-2021-5683-1072556 FDA-CBER-2021-5683-1072557 FDA-CBER-2021-5683-1072558 FDA-CBER-2021-5683-1072559 FDA-CBER-2021-5683-1072560 FDA-CBER-2021-5683-1072561 FDA-CBER-2021-5683-1072562 FDA-CBER-2021-5683-1072563…
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1 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 12 , 2021; 1: 45 – 2:15 PM EDT FDA Participants: Marion Gruber, Ph.D. Mary Malarkey Ramachandra Naik, Ph.D. …
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From: Naik, Ramachandra <[email protected]> Sent: Tuesday, August 10, 2021 12:01 PM To: Harkins Tull, Elisa <[email protected]> Cc: Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Subject: BLA 125742/0 – COMIRNATY (COVID -19 Vaccine, mR NA) - Comments regarding safety- related postmarketing studies Dear…
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From: Smith, Michael (CBER) Sent: Tuesday, June 8, 2021 2:17 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: Clinical Information Request Elisa, The clinical team has the below questions for Pfizer and they requested that responses be submitted…
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From: Smith, Michael (CBER) Sent: Monday, August 9, 2021 3:18 PM To: 'Aghajani Memar, Neda' <[email protected]>; 'Harkins Tull, Elisa' <[email protected]>; 'Devlin, Carmel M' <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected] ov> Subject: STN 125742.0: Comments on the Carton and Container labels Neda, Our review of the information provided in your BLA STN 125742/0 for …
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From: Smith, Michael (CBER) Sent: Monday, August 9, 2021 12:06 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: Clinical IR RE sequencing data Elisa, The review team has the below clinical questions for you regarding study C4591001. Please…
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www.fda.gov ___________________________________________________________________________ Memorandum DATE: August 6, 2021 TO: Ramachandran Naik, OMPT/CBER/OVRR/DVRPA Laura Montague, OMPT/CBER/OVRR/DVRPA Michael Smith, OMPT/CBER/OVRR/DVRPA Susan Wollersheim , Medical Officer, OMPT/CBER/OVRR/DVRPA FROM : Oluchi Elekwachi, Regulatory Reviewer OCBQ/DCM/APLB THROUGH: Lisa Stockbridge, Branch Chief OCBQ/DCM/APLB SUBJECT: …
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From: Smith, Michael (CBER) Sent: Thursday, August 5, 2021 3:37 PM To: 'Harkins Tull, Elisa' <[email protected]>; 'Aghajani Memar, Neda' <[email protected]>; 'Devlin, Carmel M' <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected] ov> Subject: STN 125742.0: Second round of PI comments Elisa, Please find attached the second round of labeling comments on the Package Insert (PI)…