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Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency

Educational Objective
To understand the importance using regulatory decision-making when developing a COVID-19 vaccine
1 Credit CME

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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Article Information

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 (avorn@post.harvard.edu).

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.

References
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Shah  A , Marks  PW , Hahn  SM .  Unwavering regulatory safeguards for COVID-19 vaccines.   JAMA. Published online August 7, 2020. doi:10.1001/jama.2020.15725PubMedGoogle Scholar
2.
Development and licensure of vaccines to prevent COVID-19: guidance for industry. Published June 2020. Accessed August 25, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19
3.
Zhang  AD , Puthumana  J , Downing  NS ,  et al.  Assessment of clinical trials supporting US Food and Drug Administration approval of novel therapeutic agents, 1995-2017.   JAMA Netw Open. 2020;3(4):e203284. doi:10.1001/jamanetworkopen.2020.3284PubMedGoogle Scholar
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Weiland  N , LaFraniere  S , Fink  S . FDA’s emergency approval of blood plasma is now on hold. New York Times. Published August 19, 2020. Accessed August 26, 2020. https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html
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Bose  N , Roston  A . Trump hails FDA’s authorization of plasma treatment for coronavirus, after slamming agency. Reuters. Published August 23, 2020. Accessed August 26, 2020. https://www.reuters.com/article/us-health-coronavirus-usa-trump/trump-hails-fdas-authorization-of-plasma-treatment-for-coronavirus-after-slamming-agency-idUSKBN25J0OD
6.
Hahn  SM . FDA commissioner: no matter what, only a safe, effective vaccine will get our approval. Washington Post. Published August 5, 2020. Accessed August 25, 2020. https://www.washingtonpost.com/opinions/fda-commissioner-no-matter-what-only-a-safe-effective-vaccine-will-get-our-approval/2020/08/05/e897d920-d74e-11ea-aff6-220dd3a14741_story.html
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Sarpatwari  A , Kaltenboeck  A , Kesselheim  AS .  Missed opportunities on emergency remdesivir use.   JAMA. 2020;324(4):331-332. doi:10.1001/jama.2020.11932PubMedGoogle ScholarCrossref
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Center for Reproductive Rights. Federal judge orders FDA to broaden access to emergency contraceptive. Published April 5, 2013. Accessed August 25, 2020. https://www.reproductiverights.org/press-room/federal-judge-orders-fda-to-broaden-access-to-emergency-contraception
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Kamisar  B , Holzberg  M . Poll: less than half of Americans say they’ll get a coronavirus vaccine. NBC News. Published August 18, 2020. Accessed August 25, 2020. https://www.nbcnews.com/politics/2020-election/poll-less-half-americans-say-they-ll-get-coronavirus-vaccine-n1236971
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