US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
Gilead Sciences, Inc., Foster City, California 94404, USA.
Toxicol Sci. 2022 Jan 24;185(2):119-127. doi: 10.1093/toxsci/kfab130.
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.
COVID-19（新冠肺炎），由 SARS-CoV-2（严重急性呼吸系统综合征冠状病毒 2）引起的疾病，是一场持续的全球公共卫生紧急事件。随着对 COVID-19 健康影响的认识不断提高，全球各地的公司和机构共同努力，确定治疗方法，加快临床试验和紧急使用途径，并为患者批准治疗方法。这项工作产生了不仅可以提高生存率、减少住院时间和康复时间的治疗方法，还包括预防措施，如疫苗。本文讨论了在撰写本文时已获得紧急使用批准或授权的 3 种产品的开发计划：VELKURY（瑞德西韦，来自吉利德科学公司的直接作用抗病毒药物）、REGEN-COV（卡西米单抗和 imdevimab 抗体鸡尾酒，来自再生元制药公司）和 Comirnaty（辉瑞-BioNTech COVID-19 疫苗[辉瑞公司-BioNTech]），以及美国食品和药物管理局的观点。
