Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2021 Feb;174(2):258-260.
doi: 10.7326/M20-7357. Epub 2020 Nov 20.

Ethical and Scientific Considerations Regarding the Early Approval and Deployment of a COVID-19 Vaccine

Rafael Dal-Ré  1 , Arthur L Caplan  2 , Christian Gluud  3 , Raphaël Porcher  4
Affiliations
Editorial

Ethical and Scientific Considerations Regarding the Early Approval and Deployment of a COVID-19 Vaccine

Rafael Dal-Ré et al. Ann Intern Med. 2021 Feb.

Abstract

This commentary discusses the early licensing and deployment of a COVID-19 vaccine and how accomplishing this goal could compromise ethical principles that guide clinical research.

PubMed Disclaimer

Conflict of interest statement

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M20-7357.

References

    1. Krause P , Fleming TR , Longini I , et al; World Health Organization Solidarity Vaccines Trial Expert Group. COVID-19 vaccine trials should seek worthwhile efficacy. Lancet. 2020;396:741-743. [PMID: ] doi: 10.1016/S0140-6736(20)31821-3 - DOI - PMC - PubMed
    1. U.S. Food and Drug Administration. Emergency use authorization for vaccines to prevent COVID-19. Guidance for industry. October 2020. Accessed at www.fda.gov/media/142749/download on 16 November 2020.
    1. U.S. Food and Drug Administration. Development and licensure of vaccines to prevent COVID-19. Guidance for industry. June 2020. Accessed at www.fda.gov/media/139638/download on 16 November 2020.
    1. U.S. Department of Health and Human Services. Protection of Human Subjects. 45 CFR §46.116. Accessed at www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc... on 16 November 2020.
    1. Dal-Ré R , Avendaño C , Gil-Aguado A , et al. When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process. Clin Pharmacol Ther. 2008;83:788-93. [PMID: ] - PubMed

Publication types

Substances