September 8, 2020, Vol 324, No. 10, Pages 919-1016
Unwavering Regulatory Safeguards for COVID-19 Vaccines
Anand Shah, MD; Peter W. Marks, MD, PhD; Stephen M. Hahn, MD
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JAMA. 2020;324(10):931-932. doi:10.1001/jama.2020.15725
This Viewpoint from the FDA reviews the minimum safety and efficacy standards COVID-19 vaccine candidates would need to meet to be considered for approval, and affirms its commitments to evaluating both in diverse populations and to postmarketing surveillance as means to ensure that approval will meet the highest safety and regulatory standards based on science and evidence, not politics.