FDA Briefing Document: Vaccines and Related Biological Products Advisory Committee Meeting: October 22, 2020 | NLM

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FDA Briefing Document: Vaccines and Related Biological Products Advisory Committee Meeting: October 22, 2020

10/01/2020 12:00 AM EDT

Source: U.S. Food and Drug Administration (FDA). Published: 10/2020. This 38-page document is a briefing paper for a meeting to be held on October 22, 2020, to discuss studies that should be conducted, pre- and/or post-licensure, to evaluate the safety and efficacy of COVID-19 vaccine candidates, including in special populations (e.g., pediatric populations and pregnant women), and to further evaluate the immunogenicity and duration of effectiveness of these vaccines. The committee will also be asked to discuss the need for post-marketing safety studies following approval of a Biologics License Application (BLA) for a COVID-19 vaccine. (PDF)