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Unwavering Regulatory Safeguards for COVID-19 Vaccines

Educational Objective
To understand the importance of following unwavering regulatory safeguards when developing a COVID-19 vaccine

The coronavirus disease 2019 (COVID-19) pandemic has disrupted normal life and had significant consequences for human health, with more than 4.6 million cases and more than 150 000 deaths in the US alone as of early August 2020. Preventive public health measures such as mask usage, physical distancing, and enhanced sanitation procedures are necessary to alleviate strain on the health system and reduce community transmission, while advances in therapeutic development have potentially improved clinical outcomes for patients with severe illness. However, minimizing the risk of resurgence and enabling a safe return to normal life will require a majority of the population to develop immunity against SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19). Acceptably achieving this level of herd immunity quickly will likely require the development of safe and effective vaccines.

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Article Information

Corresponding Author: Anand Shah, MD, Deputy Commissioner for Medical and Scientific Affairs, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 (anand.shah@fda.hhs.gov).

Published Online: August 7, 2020. doi:10.1001/jama.2020.15725

Conflict of Interest Disclosures: None reported.

Additional Information: Dr Shah is deputy commissioner for Medical and Scientific Affairs, Dr Marks is director of the Center for Biologics Evaluation and Research, and Dr Hahn is commissioner, all at the US Food and Drug Administration.

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Development and licensure of vaccines to prevent COVID-19: guidance for industry. US Food and Drug Administration. June 2020. Accessed July 30, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19
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