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Vaccine development and use depend on data-driven assessment of benefits and risks, first by regulatory bodies, and then more subjectively, millions of times over, by individual physicians and patients. Some vaccines have transformed public health (polio, smallpox, measles), whereas others have failed to work (HIV, malaria) or were later found to have important unexpected adverse effects (rotavirus, the 1976 influenza vaccine).
Regulatory review of the numerous coronavirus disease 2019 (COVID-19) vaccine candidates will occur under intense clinical, economic, and political pressure. In early August 2020, President Trump predicted that a vaccine could be available before election day. Less than a week later, Russia claimed to have developed its own vaccine and was beginning widespread administration without completion of the large-scale testing that Western countries routinely require, bringing efficacy-risk questions to even wider public attention. Acknowledging the pressure the US Food and Drug Administration (FDA) faces on this front, its leadership has stated that no vaccine would receive formal approval unless it met the agency’s published standards.1
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Jerry Avorn, MD, Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120 (email@example.com).
Published Online: August 31, 2020. doi:10.1001/jama.2020.17101
Conflict of Interest Disclosures: None reported.
Funding/Support: This work was supported by grants from Arnold Ventures and the Harvard-MIT Center for Regulatory Science to Dr Kesselheim.
Role of the Funder/Sponsor: The grant funders had no role in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication.
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