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Abstract:
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At the time of writing of this abstract (September 2020), several candidate vaccines to protect against SARS-CoV-2 infection or COVID-19 disease had entered or were on track to enter large-scale phase 3 placebo-controlled randomized clinical trials. In this presentation, we will look back at a multi-disciplinary team effort to facilitate a harmonized evaluation and comparison of the efficacy of these vaccines. The effort included a proposed core set of clinical endpoints, along with considerations to guide selection of the primary endpoint(s) based on clinical and statistical reasoning. Also highlighted was the plausibility that vaccine protection against symptomatic COVID-19 could be accompanied by a shift towards more SARS-CoV-2 infections that are asymptomatic. This looking-back exercise will reveal the level of impact resulting from a fast-paced collaborative effort involving clinicians, statisticians and infectious disease experts from industry, academia and government.
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