FDA Ad Com tomorrow on development/authorization of COVID-19 vaccines

• The FDA's Vaccines and Related Biological Products Advisory Committee will virtually meet tomorrow, October 22, to discuss, in general, the development, authorization and/or licensure of COVID-19 vaccines. No specific applications will be discussed during the meeting.
• Specific areas to be covered include requisite studies to demonstrate safety and efficacy, both pre- and/or post-licensure, and special populations to be included such as kids and pregnant women. The committee will discuss the need for post-marketing safety studies following full (BLA) approval and active safety follow-up following emergency use authorization (EUA).
• The agency issued industry guidance in June (included in briefing document).
• Meeting materials
• Selected tickers: AstraZeneca (AZN -1.2%), Pfizer (PFE -1.0%), BioNTech SE (BNTX -8.0%), Johnson & Johnson (JNJ -0.2%), Moderna (MRNA -1.6%), Novavax (NVAX -4.6%), Dynavax (DVAX +0.8%), Sanofi (SNY -0.8%), GlaxoSmithKline (GSK -1.2%)
• https://seekingalpha.com/news/3624369-fda-ad-com-tomorrow-on-development-authorization-of-covidminus-19-vaccines