FDA的新疫苗审批时间很可能被推到选举之后

食品和药物管理局发布了期待已久的冠状病毒疫苗指南，该指南会说明如何为COVID-19疫苗发放紧急使用授权（EUA）。FDA专员Stephen Hahn在一份声明中表示，希望该指南能帮助 “公众了解我们基于科学的决策过程，保证疫苗的质量、安全性和有效性。” FDA表示：在3期临床试验完成后，除了紧急疫苗授权（EUA），任何疫苗的安全性数据都需要监测至少两个月，所以新疫苗审批时间很有可能被推到选举之后。

The Food and Drug Administration has released its long-awaited guidance on how it will issue Emergency Use Authorizations (EUAs) for COVID-19 vaccines.
FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help "the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy."The FDA says safety data on any vaccine will need to be monitored for at least two months after Phase 3 clinical trials are completed, likely closing the door on the possibility of approving a vaccine before Election Day.  source



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