18 Sep 2020
Doherty Seminar Series - The U.S. COVID-19 Vaccine Effort: Opportunities and Challenges for Operation Warp Speed
Professor Chris Beyrer, Johns Hopkins Bloomberg School of Public Health, recently presented a special webinar as part of the Doherty Seminar Series.
Watch the webinar
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 (OWS), 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.