The AMA sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn asking for close collaboration with the physician community as the FDA works to review COVID-19 vaccine candidates. Stressing that vaccine hesitancy is likely to be a significant barrier to widespread vaccination once a vaccine is available, the AMA asked the FDA to provide physicians with a high level of transparency around the FDA’s approval process, standards for review, and safety and efficacy data available for vaccine candidates. The letter also urges FDA to collaborate with the AMA and the broader physician community to develop outreach and education opportunities for physicians regarding the vaccine process. As several vaccine candidates move rapidly towards FDA authorization, both physicians and the public have questions about the safety and efficacy of any potential vaccine. The AMA continues to closely monitor the vaccine development and review process and work with federal regulators to ensure COVID-19 vaccines are safe and efficacious and to limit vaccine hesitancy.
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