Evaluating the Efficacy of Coronavirus Disease 2019 Vaccines.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Dan-Yu LinPeter B Gilbert

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.

References

Jul 15, 2020·The New England Journal of Medicine·Lisa A JacksonUNKNOWN mRNA-1273 Study Group
Jul 31, 2020·Nature·Noe B MercadoDan H Barouch
Aug 14, 2020·Nature·Mark J MulliganKathrin U Jansen
Aug 14, 2020·JAMA : the Journal of the American Medical Association·Shengli XiaXiaoming Yang
Aug 31, 2020·Lancet·Philip KrauseUNKNOWN World Health Organization Solidarity Vaccines Trial Expert Group
Sep 3, 2020·The New England Journal of Medicine·Cheryl KeechGregory M Glenn

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Citations

Dec 3, 2021·Environmental Science and Pollution Research International·Islam MostafaGalal Yahya
Dec 1, 2021·Journal of Medical Virology·Kawthar MohamedNima Rezaei

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