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

• 2020

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The report details the global health challenge posed by the SARS-CoV-2 pandemic, which has resulted in over 30 million cases and 900,000 deaths as of September 2020. It highlights the U.S. government's emergency responses and the development of COVID-19 vaccines. Various vaccine candidates using different technologies are undergoing Phase 3 trials to ensure safety and efficacy. The FDA's role in expediting vaccine development and regulatory guidance is emphasized. The report also covers legal requirements for vaccine licensure and Emergency Use Authorization (EUA), focusing on safety, effectiveness, and manufacturing consistency.

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Tags

Hazard: Infectious Disease

Audiences: Physicians; Public Health Professionals

Emergency Management Stage: Preparedness (Prevention / Protection)

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

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

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