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The US Regulatory System and COVID-19 VaccinesThe Importance of a Strong and Capable FDA

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has been a frustrating journey from one disappointment to the next: late access to testing, insufficient staff and inadequate funding for contact tracing, jumbled communications, and, at the end of 2020, a chaotic launch of vaccination efforts. But in one area, from the beginning of the pandemic to the present, the US has excelled: facilitating the rapid development of COVID-19 vaccines. Much of the credit has justifiably gone to the scientists who adopted and created the technology, to the companies that made the vaccines, to the participants who volunteered for clinical trials, to the National Institutes of Health, and to Operation Warp Speed, which funded several candidate vaccines, minimizing financial risk for the companies. A less recognized partner in this effort—but no less essential to its success—is the US Food and Drug Administration (FDA).

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Article Information

Corresponding Author: Joshua M. Sharfstein, MD, Bloomberg School of Public Health, Johns Hopkins University, 615 N Wolfe St, Room W1033D, Baltimore, MD 21205 (joshua.sharfstein@jhu.edu).

Published Online: February 15, 2021. doi:10.1001/jama.2021.1961

Conflict of Interest Disclosures: Dr Goodman reported receiving personal fees and nonfinancial support from GlaxoSmithKline and Intellia Therapeutics, and nonfinancial support from US Pharmacopeia outside the submitted work. Dr Borio is a vice president at In-Q-Tel. No other disclosures were reported.

Additional Contributions: We acknowledge Margaret A. Hamburg, MD (Nuclear Threat Initiative), for her suggestions. She did not receive compensation.

Additional Information: Dr Sharfstein served as the former Principal Deputy Commissioner of the US Food and Drug Administration (FDA) from 2009 to 2011. Dr Goodman served as chief scientist of the US FDA from 2009 to 2014. Dr Borio was director for medical and biodefense preparedness policy at the US National Security Council from 2017-2019 and the acting chief scientist at the US FDA from 2015 to 2017.

References
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