Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials
Author
Mehrotra, Devan VJanes, Holly E
Fleming, Thomas R
Annunziato, Paula W
Neuzil, Kathleen M
Carpp, Lindsay N
Benkeser, David
Brown, Elizabeth R
Carone, Marco
Cho, Iksung
Donnell, Deborah
Fay, Michael P
Fong, Youyi
Han, Shu
Hirsch, Ian
Huang, Ying
Huang, Yunda
Hyrien, Ollivier
Juraska, Michal
Luedtke, Alex
Nason, Martha
Vandebosch, An
Zhou, Honghong
Cohen, Myron S
Corey, Lawrence
Hartzel, Jonathan
Follmann, Dean
Gilbert, Peter B
Date
2020-10-22Journal
Annals of Internal MedicinePublisher
American College of PhysiciansType
Article
Metadata
Show full item recordAbstract
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.Identifier to cite or link to this item
http://hdl.handle.net/10713/14968ae974a485f413a2113503eed53cd6c53
10.7326/M20-6169
Scopus Count
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