Evaluating the Efficacy of Coronavirus Disease 2019 Vaccines.

Abstract

A large number of studies are being conducted to evaluate the efficacy and safety of candidate vaccines against coronavirus disease 2019 (COVID-19). Most phase 3 trials have adopted virologically confirmed symptomatic COVID-19 as the primary efficacy end point, although laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is also of interest. In addition, it is important to evaluate the effect of vaccination on disease severity. To provide a full picture of vaccine efficacy and make efficient use of available data, we propose using SARS-CoV-2 infection, symptomatic COVID-19, and severe COVID-19 as dual or triple primary end points. We demonstrate the advantages of this strategy through realistic simulation studies. Finally, we show how this approach can provide rigorous interim monitoring of the trials and efficient assessment of the durability of vaccine efficacy.

• Authors: Dan-Yu Lin, Donglin Zeng, Devan V Mehrotra, Lawrence Corey, Peter B Gilbert
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 73 Issue 8 Pg. 1540-1544 (10 20 2021) ISSN: 1537-6591 [Electronic] United States
• PMID: 33340397 (Publication Type: Journal Article, Research Support, N.I.H., Extramural)
• Copyright: © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].

Chemical References

• COVID-19 Vaccines
• Vaccines

Topics

• COVID-19
• COVID-19 Vaccines
• Humans
• SARS-CoV-2
• Treatment Outcome
• Vaccines