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- Title
Unwavering Regulatory Safeguards for COVID-19 Vaccines.
- Authors
Shah, Anand; Marks, Peter W.; Hahn, Stephen M.
- Abstract
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.
- Subjects
COVID-19; VIRAL vaccines; UNITED States. Food &; Drug Administration; DRUG efficacy; COVID-19 pandemic
- Publication
JAMA: Journal of the American Medical Association, 2020, Vol 324, Issue 10, p931
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2020.15725