COVID-19 Vaccine Approval and the FDA
COVID-19 Vaccine Approval and the FDA
Hydroxychloroquine and convalescent plasma approvals by the FDA under Emergency Use Authorization (EUA) protocols have raised concerns the agency is under withering political pressure to fast-track a COVID-19 vaccine before it is proven safe and effective. Joshua Sharfstein, MD, Johns Hopkins Bloomberg School of Public Health, and JAMA Associate Editor Preeti Malani, MD, University of Michigan, discuss implications for public health and policy responses to ensure vaccine safety. Recorded September 18, 2020.Topics discussed in this interview:
0:00 Introduction
1:02 Political interference in CDC and FDA
4:55 What is an Emergency Use Authorization (EUA)?
7:35 How long does it take to approve an EUA request?
8:44 Groups that review safety and efficacy data
11:24 Suggested steps for review and approval of EUAs
14:40 Delay created by extra review
15:07 The need for advance input and transparency
16:01 Vaccine hesitancy
18:42 Anti-masking and anti-vaccine sentiment
21:04 Messaging and countering distrust in data
23:02 FDA role and expertise in vaccines
25:40 Can an EUA be issued against FDA advice?
27:56 Vaccine trials progress update
29:58 Infrastructure for vaccine delivery
34:45 States and Federal role in vaccine delivery
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