Coronavirus Vaccine FDA Update – December 14, 2020
Coronavirus Vaccine FDA Update – December 14, 2020
Peter W. Marks, MD, PhD and Stephen M. Hahn, MD return to JAMA's Q&A series to discuss the Pfizer/BioNTech and Moderna vaccines: the data, the weekend's EUA designation (Pfizer/BioNTech), and the process for future full licensure and postmarketing safety surveillance.Dr. Marks directs the US FDA's Center for Biologics Evaluation and Research (CBER).
Dr. Hahn is @US_FDA Commissioner.
Recorded December 14, 2020.
Topics discussed in this interview:
0:00 Introduction
0:30 Last two weeks for Dr Hahn
1:58 Pfizer EUA application
2:46 Was there pressure after UK approval
4:48 Differences in EUAs for vaccines vs drugs
7:45 Surprises in data
11:01 Post-authorization safety surveillance
14:06 Unknowns: duration of protection, asymptomatic transmission, virus mutation
15:13 Safety surveillance, background events
19:23 How vaccines can reduce non-COVID-19 excess deaths
20:35 Patients with allergies
22:30 Bell’s Palsy
23:20 FDA role in vaccine manufacture and distribution
25:06 Length of immunity, asymptomatic transmission, virus mutation
27:45 Political interference
29:34 Reader comment
Watch Dr. Mark's previous appearance: https://ja.ma/marks
Watch Dr. Hahn's previous appearance: https://ja.ma/hahn
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