Journal
ANNALS OF INTERNAL MEDICINE
Volume 174, Issue 2, Pages 221-+Publisher
AMER COLL PHYSICIANS
DOI: 10.7326/M20-6169
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Categories
Funding
- National Institute of Allergy and Infectious Diseases of the National Institutes of Health [UM1AI068635, R37AI054165, R37-AI29168]
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Several COVID-19 vaccine candidates are entering large-scale phase 3 clinical trials with proposed general clinical endpoint measures to facilitate evaluation and comparison. The potential shift towards more asymptomatic SARS-CoV-2 infections alongside vaccine protection against symptomatic COVID-19 is highlighted, along with its implications.
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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