Monitoring Multiple U.S. Government-Supported Covid-19 Vaccine Trials

Sally Hunsberger; Susan S Ellenberg; Steven Joffe; Abdel Babiker; Alan Fix; Marie R Griffin; Jorge Kalil; Myron M Levine; Malegapuru W Makgoba; Reneé H Moore; Anastasios A Tsiatis; Richard Whitley

doi:10.1056/EVIDctcs2200301

Monitoring Multiple U.S. Government-Supported Covid-19 Vaccine Trials

NEJM Evid. 2023 Mar;2(3):EVIDctcs2200301. doi: 10.1056/EVIDctcs2200301. Epub 2023 Feb 28.

Authors

Affiliations

¹ National Institute of Allergy and Infectious Diseases, Rockville, MD.
² Perelman School of Medicine at the University of Pennsylvania, Philadelphia.
³ Medical Research Council Clinical Trials Unit, University College London, London.
⁴ Center for Vaccine Innovation and Access, PATH, Washington, D.C.
⁵ Vanderbilt University School of Medicine, Nashville.
⁶ Faculdade de Medicina, Universidade de São Paulo, São Paulo.
⁷ University of Maryland School of Medicine, Baltimore.
⁸ Office of Health Standards and Compliance, Pretoria, South Africa.
⁹ Dornsife School of Public Health, Drexel University, Philadelphia.
¹⁰ North Carolina State University, Raleigh, NC.
¹¹ University of Alabama at Birmingham, Birmingham, AL.

PMID: 38320019
DOI: 10.1056/EVIDctcs2200301

Abstract

Monitoring U.S. Government-Supported Covid-19 Vaccine TrialsOperation Warp Speed was a partnership created to accelerate the development of Covid-19 vaccines. The National Institutes of Health oversaw one data and safety monitoring board to review/monitor all Operation Warp Speed trials. This article describes the challenges faced in monitoring these trials and provides ideas for future similar endeavors.

MeSH terms

COVID-19 Vaccines*
COVID-19*
Clinical Trials Data Monitoring Committees
Humans
National Institutes of Health (U.S.)
United States

Substances

COVID-19 Vaccines