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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.

References
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Fact sheet: explaining Operation Warp Speed. US Dept of Health and Human Services. June 2020. Accessed July 30, 2020. https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html
2.
O’Callaghan  KP , Blatz  AM , Offit  PA .  Developing a SARS-CoV-2 vaccine at warp speed.   JAMA. Published online July 6, 2020. doi:10.1001/jama.2020.12190PubMedGoogle Scholar
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Expectations for a COVID-19 vaccine. Associated Press-NORC Center for Public Affairs. May 2020. Accessed July 30, 2020. https://apnorc.org/projects/expectations-for-a-covid-19-vaccine/
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Collins  FS , Stoffels  P .  Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): an unprecedented partnership for unprecedented times.   JAMA. 2020;323(24):2455-2457. doi:10.1001/jama.2020.8920PubMedGoogle ScholarCrossref
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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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Ensuring the safety of vaccines in the United States. US Food and Drug Administration. July 2011. Accessed July 30, 2020. https://www.fda.gov/media/83528/download
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COVID-19: developing drugs and biological products for treatment or prevention. US Food and Drug Administration. May 2020. Accessed July 30, 2020. https://www.fda.gov/media/137926/download
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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