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COVID-19 Therapeutics and Vaccines: A Race to Save Lives.
Bebenek, Ilona; Bannister, Roy; Dubinion, John; Fortin, Marie; Liu, Matt; Motter, Arianne L; Rohde, Cynthia M; Wrzesinski, Claudia.
  • Bebenek I; US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
  • Bannister R; Gilead Sciences, Inc., Foster City, California 94404, USA.
  • Dubinion J; US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
  • Fortin M; Rutgers University, New Brunswick, New Jersey 08901, USA.
  • Liu M; Regeneron Pharmaceuticals, Terrytown, New York 10591, USA.
  • Motter AL; US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
  • Rohde CM; Pfizer, Pearl River, New York 10965, USA.
  • Wrzesinski C; US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
Toxicol Sci ; 185(2): 119-127, 2022 01 24.
Article in English | MEDLINE | ID: covidwho-1501143
ABSTRACT
COVID-19 (Coronavirus Disease 2019), the disease caused by SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) is an ongoing global public health emergency. As understanding of the health effects of COVID-19 has improved, companies and agencies worldwide have worked together to identify therapeutic approaches, fast-track clinical trials and pathways for emergency use, and approve therapies for patients. This work has resulted in therapies that not only improve survival, reduce time of hospitalization, and time to recovery, but also include preventative measures, such as vaccines. This manuscript discusses development programs for 3 products that are approved or authorized for emergency use at the time of writing VEKLURY (remdesivir, direct-acting antiviral from Gilead Sciences, Inc.), REGEN-COV (casirivimab and imdevimab antibody cocktail from Regeneron Pharmaceuticals Inc.), and Comirnaty (Pfizer-BioNTech COVID-19 Vaccine [Pfizer, Inc.-BioNTech]), and perspectives from the U.S. Food and Drug Administration.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Hepatitis C, Chronic / COVID-19 Type of study: Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Toxicol Sci Journal subject: Toxicology Year: 2022 Document Type: Article Affiliation country: Toxsci

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Hepatitis C, Chronic / COVID-19 Type of study: Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Toxicol Sci Journal subject: Toxicology Year: 2022 Document Type: Article Affiliation country: Toxsci