Combined archive search across FBI Vault, SPLC, PHMPT, ACIP, NIH grants, the Federal Writers' Project, and other collections we've ingested.
Alexis Noel Ross · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2020 · $29,520 — PROJECT SUMMARY/ABSTRACT The mechanisms that control hepatic stellate cell (HSC) migration during liver development and regeneration are not well understood. This knowledge gap has hindered the generation of new therapies and the improvement of patient outcome for various developmental disorders su…
Galit Alter · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $391,727 — Since 2002, several coronaviruses have emerged able to cause severe respiratory disease, however no vaccine is available to prevent these rapidly spreading pathogens. Vaccine design has specifically lagged due to our lack of understanding of the correlates of immunity against these pathogens. Both c…
JULIE M. OVERBAUGH · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $355,912 — ABSTRACT The greatest hope for an end to the COVID19 pandemic caused by SARS-CoV-2 is a vaccine and/or antibody therapy. At this point, we know little about protective immunity to SARS-CoV-2, including which epitopes are the major target of the antibody response to this virus and whether antibodies…
Grace M Aldrovandi · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2020 · $1,225,641 — Abstract The novel SARS-CoV-2 is the cause of the coronavirus (CoV) disease (COVID-19) outbreak that currently pose a serious pandemic threat to public health. A safe vaccine that rapidly induces long-lasting virus-specific immune responses is urgently needed. The CoV spike (S) protein, a characteri…
John Laurence Kulp III · CONIFER POINT PHARMACEUTICALS, LLC · 2020 · $225,000 — Abstract Significance: To date, no specific therapeutic drug or vaccine has been approved for the treatment of human coronavirus. Better, direct-acting anti-viral drugs and accelerated methods for identifying them are desperately needed. Having a large body of diverse fragment binding simulation dat…
Joren C Madsen · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $361,494 — PROJECT SUMMARY / ABSTRACT The rapid progression of the SARS-CoV-2 pandemic and associated COVID-19 disease in the first 3 months of 2020 highlight the urgent need for research to understand the pathogenesis of the disease at the cellular level and how the immune system responds to this infection. A…
CHERYL LYNN WILLMAN · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · 2020 · $373,749 — A vaccine against SARS-CoV2 is badly needed. We have developed a vaccine platform technology based on virus-like particles (VLPs) of RNA phages like MS2, PP7, AP205 and Qß. When displayed multivalently on these bionanoparticles, peptide and protein antigens acquire a high level of immunogenicity. Th…
Jeffrey Cohen · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · 2020 · $112,386 — Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), is associated with respiratory-related disease and death. Assays to detect virus-specific antibodies are important to understand the prevalence of infection and the course of the immune re…
Joshua Hoong Yu Tan · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · 2020 · $875,573 — The overarching goal of this project is to study the immune response to pathogens at the monoclonal level to increase our understanding of basic biology and develop new tools to combat disease. We are currently focusing our efforts on human monoclonal antibodies against two pathogens, Plasmodium fal…
Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 30July2021 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 S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 02 Jul 2021FDA queries -CMC information and categorical exclusion for an environment analysis PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 4 REGARDING THE MANUFACTURING OF DRUG SUBS TANCE (DS) ............................ 5 QUERY 1 ................................ ................................…
Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 28July 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 S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel electrophoresis PFIZER CONFIDENTIAL Page 1QUERY 1 Please describe the spiked materials used for evaluating the RESPONSE 1 090177e1979cc629\Approved\Approved On: 21-Jul-2021 16:20 (GMT) (b) (4) (b) (4) FDA-CBER-2021-5683-1149349 COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 09 Jul 2021 FDA queries -RNA Integrity by capillary gel…
Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 23July2021 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 S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Page 1 of 1Date: Food and Drug Administration Center for Biologics Evaluation and Research Sample Custodian 10903 New Hampshire Avenue W075 -G707 Silver Spring, MD 20993 -0002 cc: 125742 _0/ 0003 /FC Please consider this as an official request for batch release for the following product: License Name of Product : Type of Container: Storage Conditions: Marketing Authorisation Holder: Batch Number: Date of Filling: Expiry Date: Total Quantity: Site of Manufacture: Electronic Protocol Filename…
COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 16July2021 FDA QueriesRe: LRP template IR and Samples for STN 125742/0 PFIZER CONFIDENTIAL Page 1LRPTEMPLATE FOR STN 125742/0 : QUERY 1: The lot release protocols previously submitted in amendments 125742/0.4 (dated May 24, 2021) and 125742/0.10 (dated July 9, 2021) need to be modified to be templates for use for all lots submitted to CBER. L ot release templates should be a preset format th at does not state results. …
BNT162b2 3.2.A.3.1.1 Nomenclature [ALC -0315] PFIZER CONFIDENTIAL Page 13.2.A.3.1.1. NOMENCLATURE [ALC -0315] Information on the nomenclature of AL C-0315 is provided in Table 3.2.A.3.1.1-1. Table 3.2.A.3.1.1-1. Nomenclature of ALC -0315 Nam e/code Description Company or Laboratory Code ALC -0315 : ALC -315) IUPAC Chemical Name [(4-Hydroxybutyl)azanediyl]di(hexane -6,1- diyl) bis(2- hexyldecanoate) Chemical Abstract Service Chemical NameDecanoic acid , 2-hexyl -, 1,1’…
CERTIFICATE OF ANALYSIS PHARMACIA & UPJOHN COMPANYLLC (A SUBSIDIARY OF PFIZER INC) 7000 PORTAGE RD KALAMAZOO, MI 49001 -0199USAPage 1 of 2 Generated Date: 06-2021 Item: F000051489 Title: PFE-BNT 0.5MG/ML COVIDVX25X2ML GVL EUA Expiration Date: 31-Oct-2021 Date Of Manufacture: 27-May-2021 Specification: US EUA LIMIT LOT NUMBER: FD0809 ASSOCIATED LOT: FE3194, EY0564 Documentation is considered PROPRIETARY and is made available for business operations and review by employees and regulatory…
CERTIFICATE OF ANALYSIS PHARMACIA & UPJOHN COMPANYLLC (A SUBSIDIARY OF PFIZER INC) 7000 PORTAGE RD KALAMAZOO, MI 49001 -0199USAPage 1 of 2 Generated Date: 06-2021 Item: F000051489 Title: PFE-BNT 0.5MG/ML COVIDVX25X2ML GVL EUA Expiration Date: 31-Oct-2021 Date Of Manufacture: 24-May-2021 Specification: US EUA LIMIT LOT NUMBER: FC3184 ASSOCIATED LOT: EP8663, EY0563 Documentation is considered PROPRIETARY and is made available for business operations and review by employees and regulatory…
CERTIFICATE OF ANALYSIS PHARMACIA & UPJOHN COMPANYLLC (A SUBSIDIARY OF PFIZER INC) 7000 PORTAGE RD KALAMAZOO, MI 49001 -0199USAPage 1 of 2 Generated Date: 06-2021 Item: F000051489 Title: PFE-BNT 0.5MG/ML COVIDVX25X2ML GVL EUA Expiration Date: 31-Oct-2021 Date Of Manufacture: 29-May-2021 Specification: US EUA LIMIT LOT NUMBER: FC3181 ASSOCIATED LOT: FE3195, EY0567 Documentation is considered PROPRIETARY and is made available for business operations and review by employees and regulatory…