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    Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials

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    Author
    Mehrotra, Devan V
    Janes, 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
    Show allShow less

    Date
    2020-10-22
    Journal
    Annals of Internal Medicine
    Publisher
    American College of Physicians
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.7326/M20-6169
    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.
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/14968
    ae974a485f413a2113503eed53cd6c53
    10.7326/M20-6169
    Scopus Count
    Collections
    UMB Coronavirus Publications
    UMB Open Access Articles 2020

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