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Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine

Educational Objective
To understand how to reassure the public and clinical community about the scientific review and approval of COVID-19 vaccine
1 Credit CME

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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Article Information

Corresponding Author: Howard Bauchner, MD, JAMA and the JAMA Network (howard.bauchner@jamanetwork.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.

References
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Thomson  K , Nachlis  H .  Emergency use authorizations during the COVID-19 pandemic: lessons from hydroxychloroquine for vaccine authorization and approval.   JAMA. Published online August 31, 2020. doi:10.1001/jama.2020.16253PubMedGoogle Scholar
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Kaplan S, Wu KJ, Thomas K. C.D.C. tells states how to prepare for Covid-19 vaccine by early November. New York Times. Published September 2, 2020. Accessed September 7, 2020. https://www.nytimes.com/2020/09/02/health/covid-19-vaccine-cdc-plans.html
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Dall C. CEO says Pfizer won't cut corners in COVID vaccine race. Center for Infectious Disease Research and Policy. September 3, 2020. Accessed September 7, 2020. https://www.cidrap.umn.edu/news-perspective/2020/09/ceo-says-pfizer-wont-cut-corners-covid-vaccine-race
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