Coronavirus Vaccine Update From the FDA – October 5, 2020

Peter Marks, MD, PhD directs the US FDA's Center for Biologics Evaluation and Research (CBER) and will "call the balls and strikes" on any COVID-19 vaccine, according to FDA Commissioner Stephen Hahn, MD. He joins JAMA editor Howard Bauchner, MD for an update on vaccine progress-to-date and prospects for pre-election political interference in the FDA approval process. Recorded October 5, 2020.

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Topics discussed in this interview:
0:00 Introduction
1:02 Background on CBER
2:03 Vaccine application process and EUAs
4:22 Primary data vs. summary tables
5:52 Do you get the playbook from vaccine companies?
7:53 How do you go through the data in these applications?
10:28 Vaccine safety
13:23 Mandating additional safety data
15:18 Data Monitoring Safety Board (DMSB)
16:50 FDA Advisory Committees
20:09 Do these committees weigh in before approval?
21:18 Advisory Committee on Immunization Practices (ACIP)
22:20 When does ACIP weigh in?
23:04 How long do EUAs and BLAs take?
24:17 Preventing DMSBs from prematurely terminating studies
25:35 FDA review meetings
27:42 Requesting additional information before FDA regulatory decisions
28:47 Does the FDA Advisory take a formal vote?
29:16 Career scientists at the FDA
31:34 What has this been like for you personally?
33:11 When will we see the first vaccine application?
34:28 EUA applications before the 2 month followup period

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