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

ABSTRACT

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.