Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials

AUTHORS

Mehrotra DV , Janes HE , Fleming TR , Annunziato PW , Neuzil KM , Carpp LN , Benkeser D , Brown ER , Carone M , Cho I , Donnell D , Fay MP , Fong Y , Han S , Hirsch I , Huang Y , Huang Y , Hyrien O , Juraska M , Luedtke A , Nason M , Vandebosch A , Zhou H , Cohen MS , Corey L , Hartzel J , Follmann D , Gilbert PB , . Annals of internal medicine. 2020 10 22; ().

PMID: 33090877 [PubMed].

ABSTRACT

Several vaccine candidates to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) have entered or will soon enter large-scale, phase 3, placebo-controlled randomized clinical trials. To facilitate harmonized evaluation and comparison of the efficacy of these vaccines, a general set of clinical endpoints is proposed, along with considerations to guide the selection of the primary endpoints on the basis of clinical and statistical reasoning. The plausibility that vaccine protection against symptomatic COVID-19 could be accompanied by a shift toward more SARS-CoV-2 infections that are asymptomatic is highlighted, as well as the potential implications of such a shift.

Tags: alumni publications 2020