tetano
Editor, Senior Moderator
Ann Intern Med
. 2020 Oct 22.
doi: 10.7326/M20-6169. Online ahead of print.
Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials
Devan V Mehrotra[SUP] 1 [/SUP], Holly E Janes[SUP] 2 [/SUP], Thomas R Fleming[SUP] 3 [/SUP], Paula W Annunziato[SUP] 4 [/SUP], Kathleen M Neuzil[SUP] 5 [/SUP], Lindsay N Carpp[SUP] 2 [/SUP], David Benkeser[SUP] 6 [/SUP], Elizabeth R Brown[SUP] 3 [/SUP], Marco Carone[SUP] 3 [/SUP], Iksung Cho[SUP] 7 [/SUP], Deborah Donnell[SUP] 2 [/SUP], Michael P Fay[SUP] 8 [/SUP], Youyi Fong[SUP] 2 [/SUP], Shu Han[SUP] 9 [/SUP], Ian Hirsch[SUP] 10 [/SUP], Ying Huang[SUP] 2 [/SUP], Yunda Huang[SUP] 2 [/SUP], Ollivier Hyrien[SUP] 2 [/SUP], Michal Juraska[SUP] 2 [/SUP], Alex Luedtke[SUP] 11 [/SUP], Martha Nason[SUP] 8 [/SUP], An Vandebosch[SUP] 12 [/SUP], Honghong Zhou[SUP] 9 [/SUP], Myron S Cohen[SUP] 13 [/SUP], Lawrence Corey[SUP] 3 [/SUP], Jonathan Hartzel[SUP] 1 [/SUP], Dean Follmann[SUP] 8 [/SUP], Peter B Gilbert[SUP] 3 [/SUP]
Affiliations
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.
. 2020 Oct 22.
doi: 10.7326/M20-6169. Online ahead of print.
Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials
Devan V Mehrotra[SUP] 1 [/SUP], Holly E Janes[SUP] 2 [/SUP], Thomas R Fleming[SUP] 3 [/SUP], Paula W Annunziato[SUP] 4 [/SUP], Kathleen M Neuzil[SUP] 5 [/SUP], Lindsay N Carpp[SUP] 2 [/SUP], David Benkeser[SUP] 6 [/SUP], Elizabeth R Brown[SUP] 3 [/SUP], Marco Carone[SUP] 3 [/SUP], Iksung Cho[SUP] 7 [/SUP], Deborah Donnell[SUP] 2 [/SUP], Michael P Fay[SUP] 8 [/SUP], Youyi Fong[SUP] 2 [/SUP], Shu Han[SUP] 9 [/SUP], Ian Hirsch[SUP] 10 [/SUP], Ying Huang[SUP] 2 [/SUP], Yunda Huang[SUP] 2 [/SUP], Ollivier Hyrien[SUP] 2 [/SUP], Michal Juraska[SUP] 2 [/SUP], Alex Luedtke[SUP] 11 [/SUP], Martha Nason[SUP] 8 [/SUP], An Vandebosch[SUP] 12 [/SUP], Honghong Zhou[SUP] 9 [/SUP], Myron S Cohen[SUP] 13 [/SUP], Lawrence Corey[SUP] 3 [/SUP], Jonathan Hartzel[SUP] 1 [/SUP], Dean Follmann[SUP] 8 [/SUP], Peter B Gilbert[SUP] 3 [/SUP]
Affiliations
- PMID: 33090877
- DOI: 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.