Department of Infectious Diseases, Cleveland Clinic, Cleveland, Ohio, USA.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Clin Infect Dis. 2022 May 3;74(9):1686-1690. doi: 10.1093/cid/ciab880.
Given the urgent need for treatments during the coronavirus disease 2019 pandemic, the US Food and Drug Administration issued emergency use authorizations (EUAs) for multiple therapies. In several instances, however, these EUAs were issued before sufficient evidence of a given therapy's efficacy and safety were available, potentially promoting ineffective or even harmful therapies and undermining the generation of definitive evidence. We describe the strengths and weaknesses of the different therapeutic EUAs issued during this pandemic. We also contrast them to the vaccine EUAs and suggest a framework and criteria for an evidence-based, trustworthy, and publicly transparent therapeutic EUA process for future pandemics.
鉴于在 2019 冠状病毒病大流行期间对治疗方法的迫切需求，美国食品和药物管理局 (FDA) 为多种疗法发布了紧急使用授权 (EUA)。然而，在某些情况下，这些 EUA 是在缺乏充分证据证明某种疗法的疗效和安全性的情况下发布的，这可能会推广无效甚至有害的疗法，并破坏确定性证据的产生。我们描述了在此次大流行期间发布的不同治疗性 EUA 的优缺点。我们还将它们与疫苗 EUA 进行了对比，并为未来的大流行提出了一个基于证据、值得信赖和公开透明的治疗性 EUA 流程的框架和标准。
