FDA Briefing Document: Vaccines and Related Biological Products Advisory Committee Meeting

• 2020

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This document from October 22, 2020 focuses on the development and approval of COVID-19 vaccines. It describes the challenges posed by the pandemic and outlines efforts to create safe and effective vaccines quickly. It highlights different vaccine technologies being tested in clinical trials and also explains legal requirements for vaccine approval or emergency use authorization (EUA). The FDA emphasizes safety evaluations, including studies on special populations like children and pregnant women. Overall, it stresses transparency while ensuring that only safe vaccines are approved for public use.

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Tags

Focus Area: Infectious Disease

Audiences: Physicians; Public Health Professionals

Emergency Management Stage: Preparedness (Prevention / Protection)

Keywords: Disease Outbreaks; Public Health; Vaccines; Vaccine Development; Pandemics; Immunogenicity, Vaccine; COVID-19; SARS-CoV-2; COVID-19 Vaccines; Pandemic Preparedness

Institutions: U.S. Food and Drug Administration; U.S. Department of Health and Human Services (HHS)

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