In this Doherty Seminar Series webinar, Chris Beyrer presents The U.S. COVID-19 Vaccine Effort: Opportunities and Challenges for Operation Warp Speed.
The U.S. has embarked on an unprecedented “all of government” approach to rapid evaluation and implementation of preventive vaccines against COVID-19, the clinical syndrome caused by the novel coronavirus, SARS-CoV-2. At least five phase III efficacy trials of candidate vaccines are proposed to begin in 2020, under the auspices of Operation Warp Speed, and the first two are now enrolling. The trials are harmonised across designs, with an estimated 30,000 participants each, and with respect to clinical disease endpoints. They are diverse as to candidate products, with mRNA, live vectored, and protein subunit candidates, all aimed at the SARS-CoV-2 spike antigen. Enormous challenges lie ahead for this effort, including protecting the scientific and regulatory integrity of these trials in an increasingly fraught US political environment. This presentation describes OWS, the design and implementation of the efficacy trials effort, and the controversies underway as these trials unfold in the world’s most extensive epidemic of COVID-19, in a national election season, and during a period of national reckoning around systemic racism, including the health disparities which have marked the US epidemic.
Chris Beyrer MD, MPH, is the inaugural Desmond M. Tutu Professor in Public Health and Human Rights at the Johns Hopkins Bloomberg School of Public Health. He is a Professor of Epidemiology, International Health, Health Behavior and Society, Nursing and Medicine at Johns Hopkins. He serves as Director of the Johns Hopkins Training Program in HIV Epidemiology and Prevention Science and as Founding Director of the Center for Public Health and Human Rights. He is the Associate Director of the Johns Hopkins Center for AIDS Research (CFAR) and of the University’s Center for Global Health. Dr. Beyrer has extensive experience in conducting international collaborative research and he has spent much of his career focusing on health and human rights. He was President of the International AIDS Society from 2014-16, and was elected to membership in the National Academy of Medicine in 2014. He currently serves as Senior Scientific Liaison to the COVID-19 Vaccine Prevention Network.