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Research, Methods, Statistics

The Ethics of Continuing Placebo in SARS-CoV-2 Vaccine Trials

Educational Objective
To identify the key insights or developments described in this article

1 Credit CME

JAMA

Published Online: December 14, 2020

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Article Information and Disclosures

Annette Rid, MD¹;

Marc Lipsitch, DPhil²;

Franklin G. Miller, PhD³

Author Affiliations

¹Department of Bioethics, The Clinical Center, National Institutes of Health, Bethesda, Maryland
²Center for Communicable Disease Dynamics, Department of Epidemiology, Department of Immunology and Infectious Diseases, Harvard T. H. Chan School of Public Health, Boston, Massachusetts
³Weill Cornell Medical College, New York, New York

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As the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic continues to rage, developing safe and effective vaccines is critically important. With unprecedented speed, multiple candidate vaccines are now being evaluated in placebo-controlled clinical trials that have enrolled hundreds of thousands of participants.

According to Pfizer-BioNTech and Moderna, interim analyses after approximately 2 months of follow-up suggest their vaccines are 90% to 95% effective at preventing SARS-CoV-2 infection, although no peer review of the data has been conducted to date. Both companies now claim they have an “ethical obligation” to offer vaccine as soon as possible to all participants who received placebo, considering the strong results and participants’ contribution to the research.¹^,2

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Article Information

Corresponding Author: Annette Rid, MD, Clinical Center Department of Bioethics, National Institutes of Health, 10 Center Dr, Bldg 10, Room 1C118, Bethesda, MD 20892 (annette.rid@nih.gov).

Published Online: December 14, 2020. doi:10.1001/jama.2020.25053

Conflict of Interest Disclosures: Dr Lipsitch reported receipt of honoraria/consulting fees from Merck, Affinivax, Sanofi Pasteur, Bristol Myers Squibb, and Antigen Discovery; receipt of research funding (institutional) from Pfizer; and provision of unpaid scientific advice to Janssen, AstraZeneca, One Day Sooner, and COVAXX (United Biomedical). No other disclosures were reported.

Funding/Support: This work was supported in part by the Clinical Center Department of Bioethics, which is in the Intramural Program of the National Institutes of Health.

Role of the Funder/Sponsor: The funder had no role in the preparation, review, or approval of the manuscript or decision to submit the manuscript for publication.

Disclaimer: The views expressed herein are those of the authors and do not necessarily reflect the policies of the National Institutes of Health or the US Department of Health and Human Services.

References

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Grady D . Early data show Moderna’s coronavirus vaccine is 94.5% effective. New York Times. Published November 16, 2020. Accessed December 2, 2020. https://www.nytimes.com/2020/11/16/health/Covid-moderna-vaccine.html

Sun LH . First 6.4 million doses of Pfizer’s coronavirus vaccine could go out in mid-December. Washington Post. Published November 24, 2020. Accessed December 2, 2020. https://www.washingtonpost.com/health/2020/11/24/vaccine-plan-first-doses/

Bell BP , Romero JR , Lee GM . Scientific and ethical principles underlying recommendations from the Advisory Committee on Immunization Practices for COVID-19 vaccination implementation. JAMA. 2020;324(20):2025-2026. doi:10.1001/jama.2020.20847 PubMed Google Scholar Crossref

Lipsitch M , Jha A , Simonsen L . Observational studies and the difficult quest for causality: lessons from vaccine effectiveness and impact studies. Int J Epidemiol. 2016;45(6):2060-2074. doi:10.1093/ije/dyw124 PubMed Google Scholar

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Rid A , Wendler D . A framework for risk-benefit evaluations in biomedical research. Kennedy Inst Ethics J. 2011;21(2):141-179. doi:10.1353/ken.2011.0007 PubMed Google Scholar Crossref

Herper M . Pfizer says placebo patients will eventually get its Covid-19 vaccine; the question of when is complicated. STAT News. Published November 12, 2020. Accessed December 2, 2020. https://www.statnews.com/2020/11/12/pfizer-says-placebo-patients-will-eventually-get-its-covid-19-vaccine-the-question-of-when-is-complicated/

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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;;
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