COVID-19 Therapeutics and Vaccines: A Race to Save Lives

被引：10
作者：
Bebenek, Ilona [1 ]
Bannister, Roy [2 ]
Dubinion, John [1 ]
Fortin, Marie [3 ]
Liu, Matt [4 ]
Motter, Arianne L. [1 ]
Rohde, Cynthia M. [5 ]
Wrzesinski, Claudia [1 ]
机构：
[1] US FDA, Silver Spring, MD 20993 USA
[2] Gilead Sci Inc, Foster City, CA 94404 USA
[3] Rutgers State Univ, New Brunswick, NJ 08901 USA
[4] Regeneron Pharmaceut, Tarrytown, NY 10591 USA
[5] Pfizer, Pearl River, NY 10965 USA
来源：
TOXICOLOGICAL SCIENCES | 2022年 / 185卷 / 02期
关键词：
COVID-19; clinical trial; drug development; pandemic; public health emergency; regulatory; SARS-CoV-2; toxicology; IMMUNIZATION; GS-5734;
D O I：
10.1093/toxsci/kfab130
中图分类号：
R99 [毒物学（毒理学）];
学科分类号：
100405 ;
摘要：
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.
引用
收藏
页码：119 / 127
页数：9
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