Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials

Ann Intern Med. 2021 Feb;174(2):221-228. doi: 10.7326/M20-6169. Epub 2020 Oct 22.

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.

MeSH terms

  • Asymptomatic Infections
  • COVID-19 / diagnosis
  • COVID-19 / prevention & control*
  • COVID-19 Testing
  • COVID-19 Vaccines / adverse effects
  • COVID-19 Vaccines / therapeutic use*
  • Clinical Trials, Phase III as Topic / methods
  • Humans
  • Randomized Controlled Trials as Topic / methods*
  • SARS-CoV-2
  • Severity of Illness Index

Substances

  • COVID-19 Vaccines