October 05, 2020

Emergency Use Authorization, Public Trust, and Vaccines

 

Wednesday, October 7th, 2020 (4:00 – 5:00 PM EDT)

Event RSVP: duke.is/g4sciZ

Co-Hosted with the Duke Center for Innovation Policy, the Duke Global Health Institute, the Duke Human Vaccine Institute, Duke University School of Law, the Harvard Petrie-Flom Center For Bioethics, the Johns Hopkins Berman Institute for Bioethics, the Sabin Vaccine Institute, the Stanford Law School Center for Law and the Biosciences, and the Yale School of Public Health.

Nine months in, the race to create a safe, effective COVID-19 vaccine is beginning to bear fruit.  Several Phase 3 clinical trials are underway, and political pressure is mounting to deliver a vaccine before the end of the year. The only way to meet this deadline would be for the FDA to issue an emergency use authorization (EUA) for one of these vaccines. Observers are concerned, however, that an EUA-authorized vaccine may not be both safe and effective, and worry about the impact of a premature authorization on public trust in the FDA, any COVID vaccine issued this way, and even subsequent COVID vaccines.

Join Duke Science & Society and our esteemed panel of experts, including former FDA Commissioner, Rob Califf, and Founder and Director of the Scripps Research Translational Institute, Eric Topol, for a timely discussion of the suitability of the EUA process for a COVID vaccine, and the safety and efficacy that we can expect from vaccines authorized on an accelerated timeframe.

 

Panelists:

Robert M Califf, M.D. M.A.C.C.: Donald F. Fortin, M.D. Distinguished Professor of Cardiology, Duke University School of Medicine, 22nd Commissioner of the United States Food and Drug Administration

Eric Topol, M.D.: Gary & Mary West Endowed Chair of Innovative Medicine, Executive VP, Professor, Molecular Medicine, Scripps Research, Founder and Director of the Scripps Translational Institute

Moderator:

Arti K Rai, J.D.; Elvin R. Latty Professor of Law and Faculty Director, the Center for Innovation Policy at Duke Law