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

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To identify the key insights or developments described in this article
1 Credit CME

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
1.
Branswell  H . Pfizer may be within days of filing emergency authorization request for Covid-19 vaccine. STAT News. Published November 17, 2020. Accessed December 2, 2020. https://www.statnews.com/2020/11/17/pfizer-may-be-within-days-of-filing-emergency-authorization-request-for-covid-19-vaccine/
2.
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
3.
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/
4.
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.2020.20847PubMedGoogle ScholarCrossref
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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/dyw124PubMedGoogle Scholar
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Wendler  D , Ochoa  J , Millum  J , Grady  C , Taylor  HA .  COVID-19 vaccine trial ethics once we have efficacious vaccines.   Science. Published online December 3, 2020. doi:10.1126/science.abf5084PubMedGoogle 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.2011.0007PubMedGoogle ScholarCrossref
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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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