Public perception of the review of medications and vaccines for coronavirus disease 2019 (COVID-19) has become enmeshed in politics. The pressure on the US Food and Drug Administration (FDA) and Commissioner Stephen Hahn, MD, to approve the broad use of a COVID-19 vaccine in the coming months will be immense. However, a lack of clarity about the agency’s approach—coupled with a stream of announcements from various federal agencies and pharmaceutical companies—has led to confusion and concern. Greater clarity and transparency about the review process as well as the full engagement of the relevant federal advisory committees can inspire understanding and trust.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Howard Bauchner, MD, JAMA and the JAMA Network (firstname.lastname@example.org).
Published Online: September 10, 2020. doi:10.1001/jama.2020.18860
Conflict of Interest Disclosures: None reported.
Additional Information: Dr Sharfstein reported serving as Principal Deputy Commissioner of the FDA from March 2009 to January 2011.
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