- The FDA's Vaccines and Related Biological Products Advisory Committee will meet on Thursday, October 22, to discuss pre- and post-licensure clinical trials needed to further evaluate the immunogenicity and duration of effectiveness of COVID-19 vaccines.
- The committee will also be asked to discuss the need for post-marketing studies following full approval of a COVID-19 vaccine and the requirements for active safety follow-up after emergency use authorization (EUA).
- Briefing materials (link at bottom)
- Selected tickers: Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE), BioNTech SE (NASDAQ:BNTX), Johnson & Johnson (NYSE:JNJ), AstraZeneca (NASDAQ:AZN), Sanofi (NASDAQ:SNY), GlaxoSmithKline (NYSE:GSK), Merck (NYSE:MRK), Dynavax (NASDAQ:DVAX), Novavax (NASDAQ:NVAX)
- https://seekingalpha.com/news/3620151-fda-ad-com-this-month-to-clarify-covidminus-19-vaccine-authorization-requirements
Tuesday, October 6, 2020
FDA Ad Com this month to clarify COVID-19 vaccine authorization requirements
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