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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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Corresponding Author: Annette Rid, MD, Clinical Center Department of Bioethics, National Institutes of Health, 10 Center Dr, Bldg 10, Room 1C118, Bethesda, MD 20892 (firstname.lastname@example.org).
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.
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