使用替代终点加速新型冠状病毒肺炎疫苗研发的监管考量

Regulatory considerations for using surrogate endpoints to accelerate the development of COVID-19 vaccines

在疫苗研发中替代终点越来越受到关注,近期由于新型冠状病毒肺炎疫情(简称新冠疫情)加剧、新冠病毒突变体频出、国际市场疫苗供应短缺,使用替代终点加速疫苗研发上市是未来有潜力的方向。本文通过总结目前已上市新型冠状病毒肺炎疫苗使用的临床终点,探讨使用替代终点评价疫苗效力的路径,在新冠疫情日益严峻的背景下,为未来疫苗研发和审评选择替代终点加速疫苗上市提供可操作的监管建议。

In the research and development(R&D)of vaccines,surrogate endpoints have attracted more and more attention.Recently,using surrogate endpoints to accelerate vaccine R&D and marketing has become a potential direction in the future due to the intensification of the COVID-19 pandemic,the frequent occurrence of new coronavirus mutants,and the shortage of vaccine supply in the international market.This article summarized the clinical endpoints of the currently marketed new coronavirus(SARS-CoV-2)vaccines and explored the way to use surrogate endpoints to evaluate the efficacy of vaccines.In the context of the increasingly severe COVID-19 pandemic,this article provides practicable regulatory suggestions for future vaccine R&D and review to select surrogate endpoints to accelerate the approval of vaccines.