Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials

Devan V. Mehrotra(Decision Sciences (United States)), Holly Janes(Fred Hutch Cancer Center), Thomas R. Fleming(University of Washington), Paula W. Annunziato(Merck & Co., Inc., Rahway, NJ, USA (United States)), Kathleen M. Neuzil(University of Maryland, Baltimore), Lindsay N. Carpp(Fred Hutch Cancer Center), David Benkeser(Emory University), Elizabeth R. Brown(University of Washington), Marco Carone(University of Washington), Iksung Cho(Novavax (United States)), Deborah Donnell(Fred Hutch Cancer Center), Michael P. Fay(National Institute of Allergy and Infectious Diseases), Youyi Fong(Fred Hutch Cancer Center), Shu Han(Moderna Therapeutics (United States)), Ian Hirsch(AstraZeneca (United Kingdom)), Ying Huang(Fred Hutch Cancer Center), Yunda Huang(Fred Hutch Cancer Center), Ollivier Hyrien(Fred Hutch Cancer Center), Michal Juraska(Fred Hutch Cancer Center), Alex Luedtke(University of Washington), Martha Nason(National Institute of Allergy and Infectious Diseases), An Vandebosch(Janssen (Belgium)), Honghong Zhou(Moderna Therapeutics (United States)), Myron S. Cohen(University of North Carolina at Chapel Hill), Lawrence Corey(University of Washington), Jonathan Hartzel(Decision Sciences (United States)), Dean Follmann(National Institute of Allergy and Infectious Diseases), Peter B. Gilbert(University of Washington)
Annals of Internal Medicine
October 22, 2020
10.7326/m20-6169
Cited by 115Open Access
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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.

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