CDC ACIP — Vaccine Advisory Committee
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/ Slides
· 6 pages
Introduction to Session: Combined Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B vaccine (Vaxelis) Jamie Loehr, MD Chair, ACIP Hib/Meningococcal Vaccines Work Group June 26, 2024National Center for Immunization & Respiratory Diseases 1 ACIP Meningococcal/Hib Vaccines Work Group ▪ ACIP Members on the WG •Jamie Loehr (Chair) •Wilbur Chen ▪ Ex Officio WG Members •Margaret Bash (FDA) •Matthew Clark (IHS)…
CDC ACIP — Vaccine Advisory Committee
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/ Slides
· 53 pages
Evidence to Recommendations and Proposed Recommendations: Use of Vaxelis among American Indian and Alaska Native Infants Jennifer Collins, MD, MSc Co-Lead, ACIP Hib/Meningococcal Vaccines Work Group June 26, 2024National Center for Immunization & Respiratory Diseases 2▪Capsular polysaccharide (PRP) conjugated to carrier proteins –Tetanus toxoid (PRP -T) –Outer membrane protein of meningococcal serogroup B (PRP -OMP) ▪Highly immunogenic via activation of T -cell dependent immunity –95% of…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Silver Spring, MD 20993 STN 125742/0 Test Memo – H. Wang 1 To: STN 125742/0 From : Hsiaoling Wang , Ph.D., Analyst , CBER/ OCBQ/D BSQC/ LACBRP Through: Tao Pan, Ph.D., Team Lead, CBER/OCBQ/DBSQC/LACBRP Kori Francis, Acting Lab Chief , CBER/OCBQ/DBSQC/LACBRP Maryna Eichelberger, Ph.D., Division Director, CBER/OCBQ/DBSQC Mary A. Malarkey, Office Director , CBER/OCBQ Applicant: …
Pfizer Documents (PHMPT/FDA)
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· 2 pages
DEPARTMENT OF HEALTH AND HUMAN SERV ICES Food and Drug Administration Silver Spring MD 20993 MEMORANDUM FOR RECORD To STN # 125 742/0 August 20, 2021 From Hyesuk Kong, Ph. D. Karla Garcia, M.S. Seth Schult e, M.S. Laboratory of Microbiology, In -vivo Testing & Standards (LMIV TS) Division of Biological Standards and Quality Control (DBSQC) Office of Compliance and Biologics Quality…
Pfizer Documents (PHMPT/FDA)
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· 9 pages
1 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: ADDENDUM MEMORANDUM From: Meghna Alimchandani, MD Deputy Director, Division of Epidemiology (DE) Kerry Welsh, MD Medical Officer, Analytic Epidemiology Branch (AEB) To: Ramachandra Naik, PhD Chair, Review…
Pfizer Documents (PHMPT/FDA)
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· 5 pages
Center for Biologics Evaluation and Research Laboratory Quality System COMIRNATY (BioNTech Manufacturing GmbH) COVID -19 mRNA Vaccine Document ID: 1 25742 Revision Level: 01 Revision Date: Effective Date: Total Pages: 5 (including this cover page) Document Uncontrolled if Printed Author Approval: _______________ - 1 - WARNING: The information contained in this document is CONFIDENTIAL and should not be released. See FOIA exemption regarding…
Pfizer Documents (PHMPT/FDA)
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· 5 pages
Center for Biologics Evaluation and Research Laboratory Quality System COMIRNATY (BioNTech Manufacturing GmbH) COVID -19 mRNA Vaccine Document ID: 1 25742 Revision Level: 01 Revision Date: Aug ust 20, 2021 Effective Date: August 20, 2021 Total Pages: 5 (including this cover page) - 1 - WARNING: The information contained in this document is CONFIDENTIAL and should not be released. See FOIA exemption regarding circumvention. Product Testing Plans document…
Pfizer Documents (PHMPT/FDA)
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· 31 pages
1 Date: August 20, 2021 From: Daphne D. Stewart, CSO Regulatory Management Support Branch, DVRPA/OVRR Through: Tim D. Nelle, Ph.D. , CAPT U.S. Public Health Service, Branch Chief, RMSB To: BLA STN 125742/0 File Subject Review of BioNTech Manufacturing GmbH – BLS 125742/0 COVID- 19 mRNA Vaccine (nucleoside modified) – COMIRNATY ® Carton and Container Labeling Background This Biologic License Application (BLA) is for COVID- 19 mRNA Vaccine (nucleoside modified)…
Pfizer Documents (PHMPT/FDA)
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· 7 pages
From: DeCiero, Daniel Sent: Thursday, August 19, 2021 12:48 PM To: Zubkova, Iryna Cc: Peters, Lori; Naik, Ramachandra; Smith, Michael (CBER); Gottschalk, Laura; Ertel, Donald; Sausville, Robert; Anderson, Maria (CBER); Mendoza, Melissa; Malarkey, Mary Subject: RE: Request for Compliance Check BLA STN 125742/0 • Applicant Name: BioNTech Manufacturing GmbH • Product Names: 125742/0 - COVID -19 mRNA Vaccine (COMIRNATY) • License Number: 2229 • Address: BioNTech…
Pfizer Documents (PHMPT/FDA)
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· 16 pages
Statistical Review STN: 125742/0 Page i Application Type BLA, Original Application STN 125742/0 CBER Received Date May 18, 2021 PDUFA Goal Date January 16, 2022 Division / Office DVRPA /OVRR Committee Chair Ramachandra Naik Clinical Reviewer(s) Ann Schwartz; Susan Wollersheim Project Manager Michael Smith; Laura Gottschalk Priority Review Yes Reviewer Name Ye Yang , Mathematical Statistician, DB/VEB Review Completion Date / Stamped Date Concurrence …
Pfizer Documents (PHMPT/FDA)
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· 26 pages
Stati stical Review STN: 125742/0 Page i Application Type BLA, Original Application STN 125742/0 CBER Received Date May 18, 2021 PDUFA Goal Date January 16, 2022 Division / Office DVRPA /OVRR Committee Chair Ramachandra Naik Clinical Reviewer(s) Ann Schwartz; Susan Wollersheim Project Mana ger Mike Smith ; Laura Gottsch alk Priority Review Yes Reviewer Name(s) Lei Huang Review Completion Date / Stamped Date Supervisory Concur rence Tsai-Lien Lin, Bra…
Pfizer Documents (PHMPT/FDA)
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· 79 pages
Establishment Inspection Report FEI: 1000654629 Pfizer Manufacturing Belgium NV EI Start: 06/24/2021 Puurs, Belgium EI End: 07/02/2021 1 of 79 TABLE OF CONTENTS Summary ............................................................................................................................... 1 Administrative Data ............................................................................................................... 2 Persons Interv iewed …
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Smith, Michael (CBER) Sent: Wednesday, August 18, 2021 2:51 PM To: 'Harkins Tull, Elisa' <[email protected]>; 'Rohlfing, Paul' <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; 'Aghajani Memar, Neda' <[email protected] >; 'Devlin, Carmel M' <[email protected]> Subject: STN 125742.0: DBSQC comments Elisa and Paul, Our review of the information provided in…
Pfizer Documents (PHMPT/FDA)
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· 3 pages
From: Smith, Michael (CBER) Sent: Wednesday, August 18, 2021 4:01 PM To: Rohlfing, Paul <[email protected]> Cc: Gottschalk, Laura <[email protected]>; Naik, Ramachandra <[email protected]>; Aghajani Memar, Neda <[email protected]>; Harkins Tull, Elisa <[email protected]> Subject: RE: [EXTERNAL] FW: STN 125742.0: IR RE sh elf life and date of manufacture Paul, Regarding your question, we expect that it will be sufficient…
Pfizer Documents (PHMPT/FDA)
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· 1 page
From: Jones, Kathleen (CBER) <[email protected]> Sent: Monday, August 30, 2021 5:26 PM To: Smith, Michael (CBER) <[email protected]>; Peters, Lori <[email protected]>; Fontan, Laura <[email protected]>; Price, Gregory <[email protected]>; Lynch, Christian <[email protected]>; Emerson, Debra <[email protected]>; Eltermann, John <[email protected]>; Renshaw, Carolyn <[email protected]>; Allen, Ekaterina…
Pfizer Documents (PHMPT/FDA)
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· 1 page
From: Wang, Hsiaoling <[email protected]> Sent: Monday, August 30, 2021 3:10 PM To: Smith, Michael (CBER) <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Sutkowski, Elizabeth M. <[email protected]>; Eichelberger, Maryna <[email protected]>; Pan, Tao <[email protected]>; Francis, Kori <[email protected]> Subject: RE: STN 125742.0.41: Response to DBSQC…
Pfizer Documents (PHMPT/FDA)
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· 3 pages
FDA-CBER-2021-5683-1150219 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 w ww.fda.gov Our STN: BL 125742/0 UNIQUE INGREDIENT IDENTIFIER (UNII) CODE ASSIGNMENT August 6, 2021 BioNTech Manufacturing GmbH Attention: Elisa Harkins Pfizer Inc. 500 Arcola Road Collegeville , PA 19426 Dear Ms. Harkins : The Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85) (FDAAA) requires that establishment…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
From: Smith, Michael (CBER) Sent: Thursday, August 5, 2021 3:13 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: Diluent questions Elisa, The review team has the below questions regarding the…
Pfizer Documents (PHMPT/FDA)
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· 5 pages
From: Smith, Michael (CBER) Sent: Thursday, August 5, 2021 1:48 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: 11 Facilities questions Elisa, The review team has the below 11 facilities questions,…
Pfizer Documents (PHMPT/FDA)
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· 1 page
From: Gottschalk, Laura Sent: Thursday, August 5, 2021 11:45 AM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]> Subject: STN 125742/0 Proper Name Dear Ms. Harkins, Please note that the PROPER NAME to be used for your product in this BLA is “COVID -19 Vaccine,…