Combined archive search across FBI Vault, SPLC, PHMPT, ACIP, NIH grants, the Federal Writers' Project, and other collections we've ingested.
Kyeong-Ok Chang · KANSAS STATE UNIVERSITY · 2021 · $774,037 — PROJECT SUMMARY Human coronaviruses generally cause the common cold, a mild upper respiratory illness, however, global outbreaks of new human coronavirus infections with severe respiratory disease have periodically emerged from animals. These include Severe Acute Respiratory coronavirus (SARS-CoV), …
Blake Marie Hauser · HARVARD MEDICAL SCHOOL · 2021 · $37,980 — Project Summary/Abstract Since the emergence of the novel severe acute respiratory syndrome virus 2 (SARS-CoV-2) coronavirus, the need for better frameworks to rapidly develop vaccines in response to emerging viral threats, including other coronaviruses of potential pandemic concern, is clear. One a…
Monica Kraft · UNIVERSITY OF ARIZONA · 2021 · $1,433,547 — In this AADCRC program renewal, we will focus on three critical and understudied innate immune factors and how they impact viral infections in asthma: the anionic phospholipids of surfactant (palmitoyl- oleoyl-phosphatidylglycerol, POPG, and phosphatidylinositol, PI), Toll interacting protein (Tolli…
Ralph S Baric · WASHINGTON UNIVERSITY · 2021 · $1,206,220 — Project Summary Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a positive-sense single-stranded RNA virus that was first isolated in Wuhan China in December, 2019. SARS-CoV-2 is the cause of coronavirus disease 2019 (COVID-19), which is now a pandemic and has caused more than 1.3 mi…
______________________________________________________________________ _________________________________________________________________ _____ Summary Basis for Regulatory Action Date: 11/8/2021 From: Ramachandra Naik, PhD, Review Committee Chair , DVRPA/OVRR BLA STN: 125742/0 Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer , Inc.) Submission Receipt Date: May 18, 2021 PDUFA Action Due Date: January 1 6, 2022 Proper Name: COVID -19 Vaccine, mRNA Proprietary Name…
Individuals using assistive technology may not be able to fully access the information contained in this file. For assistance, please call 800- 835-4709 or 240 -402-8010, extension 1. CBER Consumer Affairs Branch or send an e- mail to: [email protected] and include 508 Accommodation and the title of the document in the subject line of your e-mail. BLA 125742 Toxicology Review of COVID -19 Vaccine (BNT162, PF -07302048) (Final Report) From: Nabil, Al Humadi Through: Martin…
Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research MEMO RANDUM Date: September 13, 2021 To: Ramachandra Naik From: Hong Yang, Ph.D., Patrick Funk, Ph.D. , and Osman N. Yogurtcu , Ph.D. Analytics and Benefit -Risk Assessment Team OBE Through: Richard Forshee, Ph.D. Acting Deputy Office Director OBE Re: STN 125742/0: review memo for benefit -risk assessment Page 2 – Hong Yang – 125742/0 …
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo 4/14/2022 1 BLA 125 742/0 COMIRNATY : Documentation Review Memo Product Information: COMIRNATY Indication and Use: Active immunization to prevent coronavirus disease 2019 ( COVID -19) caused by severe acute respiratory syndrome coronavirus 2 ( SARS -CoV-2) in individuals 16 years of age and older. Communications (IRs) from CBER: IR # Request Date CBER Rep(s) Request CBER …
Clinical Reviewers: Susan Wollersheim, MD and Ann Schwartz, MD STN:125742 i BLA Clinical Review Memorandum * Application Type Biologics Licen se Application (BLA) STN 125742 /0 CBER Received Date May 18, 2021 PDUFA Goal Date January 16, 2022 Division / Office DVRPA / OVRR Priority Review (Yes/No) Yes Reviewer Name(s) Susan Wollersheim, MD Ann Schwartz, MD Review Completion Date / Stamped Date August 23, 2021 Supervisory Concurrence Lucia…
BNT162b2 3.2.P.3.2 Batch Formula PFIZER CONFIDENTIAL Page 13.2.P.3.2. BATCH FORMULA The target drug product batch size Table 3.2.P.3.2 -1presents the unit formula for one liter of formulated bulk drug product soluti on, as well as batch formula s for representative batch size s of Table 3.2.P.3.2 -1. Batch Formula for BNT162b2 Bulk Drug Product Nam e of Ingredients Reference to StandardUnit Formula per 1 L (g) BNT162b2 d rug substance In-house specification0.5 ALC -0315 In-house …
CBER Sentinel Program Sufficiency Memo: BNT162b2 (COVID- 19 Vaccine) /STN 125742 Last Updated on January 29 , 2019 1 De partment of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research CBER S ENTINEL PROGRAM SUFFICIENCY MEMORANDUM From: Joyce Obidi Health Scientist, CBER Surve illance Program Office of…
BLA 125742 Toxicology Review of COVID -19 Vaccine (BNT162, PF -07302048) (Final Report) From: Nabil, Al Humadi Through: Martin Green To: Kirk Prutzman, Ramachandra Naik, Michael Smith File: BLA 125742, original submission Product: COVID-19 Vaccine (BNT162, PF -07302048) Reviewer: Nabil Al-Humadi BLA sections reviewed: 4.2.3.2 Repeated dose toxicity studies 4.2.3.5. Reproductive and Developmental Toxicity Type and date of…
Summary Basis for Regulatory Action Date: 08/23/2021 From: Ramachandra Naik, PhD, Review Committee Chair , DVRPA/OVRR BLA STN: 125742/0 Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer , Inc.) Submission Receipt Date: May 18, 2021 PDUFA Action Due Date: January 1 6, 2022 Proper Name: COVID -19 Vaccine, mRNA Proprietary Name : COMIRNATY Indication: Active immunization to prevent coronavirus disease 2019 (COVID -19) caused by severe acute…
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 2099 3 w ww.fda.gov Our STN: BL 125742/0 BLA APPROVAL BioNTech Manufacturing GmbH August 23, 2021 Attention: Amit Patel Pfizer Inc. 235 East 42nd Street New York, NY 10017 Dear M r. Patel : Please refer to your Biologics License Application (BLA) submitted and received on May 18, 2021, under section 351(a) of the Publ ic Health Service Act (PHS Act) for COVID- 19…
From: Gottschalk, Laura Sent: Sunday, August 22, 2021 10:28 AM To: Harkins Tull, Elisa <[email protected]> Cc: Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject: STN 125742/0 - Final Draft Label: Package Inse rt Dear Ms. Harkins, We have reviewed your draft Package Insert (PI) label submitted in Amendment 74…
1 EMPLOYEE/OFFICER LIST MEMO To: The File Date: August 22, 2021 BLA: STN 1257 42/0 Sponsor: BioNTech Manufacturing G mbH Product: COVID- 19 Vaccine, mRNA (COMIRNATY) From: Laura Gottschalk , PhD (RPM) Through: Ramachandra Naik, PhD (Chair) The following officers or employees of FDA participated in the decision to approve this application and consented to be identified on this list. • Maria Allende, MD • Esmeralda Alvarado, PhD • Dennis Cato •…
CBER CMC BLA Review Memo, STN 125742, COVID -19 mRNA Vaccine (nucleoside modified) CBE R CMC BLA Review Memorandum BL A STN 125742 CO VID-19 mRNA Vaccine (nucleoside modified) [ COMIRNATYTM] CDR Do nald Ertel, Regulatory Officer , OCBQ/DMPQ/MR B1 Laura Fontan, Consumer Safety Officer , OCBQ/DMPQ/MR B1 Alifiya Ghadiali, C onsumer Safety Officer , OCBQ/DMPQ/MRBII Kathleen R. Jones, Biologist , OCBQ/DMPQ/MR B1 Nicole Li, Microbiologist , OCBQ/DMPQ/ MRB1 Gregory Price, Biologist ,…
1 Depar tment of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Epidemiology (OBE) REAL WORLD EVIDENCE BLA MEMORANDUM From : Yun Lu, PhD Mathematical Statistician Analytic s and Benefit -Risk Assessment Team ( ABRA) Office of Biostatistics and Epidemiology (OBE) CBER, FDA To: Ramachandra Naik, PhD Chair of the Review Committee …
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