Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 3 pages
www.fda.gov DATE: August 13, 2021 FROM : Haecin Chun, MS, Bioresearch Monitoring Branch (BMB) Division of Inspections and Surveillance (DIS) Office of Compliance and Biologics Quality (OCBQ) THROUGH: Dennis Cato , Chief BMB THROUGH: Carrie Mampilly, MPH, Director DIS THROUGH: Mary A. Malarkey, Director OCBQ TO : Ramachandra Naik, PhD , Chair Susan Wollersheim, MD , Clinical Reviewer CAPT Ann Schwartz, MD, Clinical Reviewer CAPT Michael…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
CMC Review Memorandum Date: August 12, 2021 To: The File From : Anissa Cheung, DVP , Product Specialist Through: Jerry Weir, DVP CC: Ramachandra Naik , DVRPA , Chair ; Michael Smith , DVRPA, RPM ; Laura Gottschalk , DVRPA, RPM ; Kathleen Jones , DMPQ, Lead Inspector Applicant n ame: Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC. STN : STN 125742/0 Amendment #25 COVID-19 mRNA Vaccine (BNT162/PF-07302048) Subject: Original BLA submission …
Pfizer Documents (PHMPT/FDA)
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· 3 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 11, 2021; 12: 00 PM - 12:39 PM EDT FDA Participants: Anissa Cheung, Ph.D. Maryna Eichelberger , Ph.D. John Eltermann,…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Smith, Michael (CBER) Sent: Wednesday, August 11, 2021 10:27 AM 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]> Subject: STN 125742.0: Diluent IR Neda, The review team has the below question regarding the diluent that is to be provided in the BLA. They have…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 2 pages
From: Smith, Michael (CBER) Sent: Tuesday, August 10, 2021 1:11 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: Testing related IR Neda, The review team has the below testing related IR and they have requested a response by Wednesday,…
Pfizer Documents (PHMPT/FDA)
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· 5 pages
From: Naik, Ramachandra < [email protected] > Sent: Monday, August 9, 2021 9:03 AM To: Rohlfing, Paul < [email protected]>; Smith, Michael (CBER) < [email protected] >; Harkins Tull, Elisa <[email protected] >; Aghajani Memar, Neda <[email protected] >; Devlin, Carmel M < [email protected] > Cc: Gottschalk, Laura < [email protected] > Subject: RE: STN 125742.0: Questions regarding valida tion of assay methods and lot…
Pfizer Documents (PHMPT/FDA)
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· 5 pages
Inspection Waiver -STN 125742/0 Page 1 of 5 _____________________________________________________________________________________________ Food and Drug Administration Center for Biologics Evaluation and Research Division of Manufacturing and Product Quality From: Kathleen R. Jones , CMC / Facility Reviewer, OCBQ/DMPQ/MRB1 Laura Fontan, CMC / Facility Reviewer, OCBQ/DMPQ/MRB1 …
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Smith, Michael (CBER) Sent: Friday, August 6, 2021 7:26 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: 3 questions RE measurement of endotoxins using the LAL procedures Elisa, The review team has the below three question for you…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
From: Smith, Michael (CBER) Sent: Friday, August 6, 2021 11:31 AM 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: RE: STN 125742.0: IR RE two DP documents Elisa, The review team has the below questions regarding the following two drug product (DP) documents 1)…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 33 pages
Department of Health and Human Services Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Epidemiology (OBE) Division of Epidemiology (DE) PHARMACOVIGILANCE PLAN REVIEW MEMORANDUM From: Deborah L. Thompson, MD, MSPH Medical Officer, Analytic Epidemiology Branch (AEB) DE, OBE, CBER, FDA To: Ramachandra Naik, PhD Chair, Review Committee Office of Vaccines Research and Review (OVRR),…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs -Vaccines Pfizer Inc. 500 Arcola Road Collegeville , PA19426 -3982 Global Product Developm ent 15 February 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN…
Pfizer Documents (PHMPT/FDA)
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· 1 page
FDA-CBER-2021-5683-1072424
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 1 page
Listing 7.7.2 Page 1of 1 BNT162b2 Protocol C4591008 Participant Reported Death PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL Generated from /dcri/ct/hero_together/lists/l_death.sas on 24MAY2021 12:45 Page 5of 1689 Subject ID Age/Sex/Race Vaccination DateDays since 1st Vaccine to Death Covid -19 Related C4591008 -6872706624 73/M/WHITE 2020 -12-16 52 Not Covid -19 Related C4591008 -7271517760 54/M/WHITE 2021 -01-14 50 Not Covid -19…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
Dear, You will be travelling to Belgium soon to visit and work on the Pfizer Puurs plant. As of April 19th,there are a few conditions for travel to Belgium from abroad, to which the traveller must comply. In your specific situation, it is important to notice the following: As a non-resident , only essential trips are allowed; in this case it’s a professional reason so this will be allowed. A PLF ( Passenger Locator Form ) will need to be completed, via this form: Passenger Locator Form |…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
COVID -19 Vaccine (BNT162, PF-07302048) BLA 125742/0 3.2.R Guidelines for Business Travel from a Red Zone to Belgium GUIDELINES FOR BUSINESS TRAVEL FROM A RED ZONE TO BELGIUM Residents returning to Belgium Non-residents travelling to Belgium Bycarortrain Byboat orplane Bycarortrain Byboat orplanePfizer as employer Traveller<48 hrs abroad >48 hrs abroad<48 hrs abroad >48 hrs abroad<48 hrs in BE >48 hrs ≤5d in BE>5d in B E <48 hrs in BE >48 hrs ≤5d in BE>5d in BE As the employer, Pfizer…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 32 pages
SARS-CoV-2 dLIA Linearity Qualification Data re VR-MQR-10211 and VR-MQR-10212 Experimental Data Listing - Linearity PFIZER CONFIDENTIAL Page 1 090177e194aedf59\Approved\Approved On: 18-Aug-2020 21:20 (GMT) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1072704 SARS-CoV-2 dLIA Linearity Qualification Data re VR-MQR-10211 and VR-MQR-10212 Experimental Data Listing - Linearity PFIZER CONFIDENTIAL Page 2 090177e194aedf59\Approved\Approved On: 18-Aug-2020 21:20 (GMT) (b) (4) (b) (4) (b) (4)…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
APPENDIX 1. SIGNATURES PROTOCOL NUMBER: C4591012 TITLE OF STUDY: 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 FINAL STUDY REPORT VERSION: 1.0 Confirmation: I confirm that this non -interventional (NI) study final report, which is final in content and has been printed from its definitive source, is a complete…
CDC ACIP — Vaccine Advisory Committee
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/ Slides
· 18 pages
Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 10 pages
Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. Adult Respiratory Syncytial Virus (RSV) Session Camille Kotton, MD Chair, Adult RSV Work Group Advisory Committee on Immunization Practices (ACIP) February 29, 2024 As a…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 48 pages
© 2024 Moderna, inc. All rights reserved.Overview of Moderna’s Investigational RSV Vaccine (mRNA-1345) in Adults ≥ 60 Years of Age Advisory Committee on Immunization Practices (ACIP) Rituparna Das, MD, PhD Feb 29, 2024The safety and efficacy of this investigational RSV vaccine have not been established in any country for any use Outline of PresentationOverview of mRNA- 1345, Moderna’s investigational RSV vaccine Pivotal Phase 2/3 trial Efficacy Safety Immunogenicity Persistence of…