COVID-19 vaccine trial ethics once we have efficacious vaccines
Open accessAbstract
Some placebo-controlled trials can continue ethically after a candidate vaccine is found to be safe and efficacious
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As effective vaccines are deployed, large phase III efficacy trials will become increasingly difficult because of ethical issues with placebo controls when an effective vaccine exists and because disease incidence is falling in countries using vaccines.
“As effective vaccines are gradually rolled out, conducting large phase III efficacy trials will become increasingly difficult — for many reasons, including the ethical issues of a placebo-controlled trial in the context of an effective vaccine being available and also the likelihood of decreasing disease incidence in countries where vaccines are being used — which are usually the same countries”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [106]
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Cites
What Makes Clinical Research Ethical?
Emanuel, E. J. (2000) · JAMA · doi:10.1001/jama.283.20.2701 · Cited by 2,710 · see citing works
Trustworthiness before Trust — Covid-19 Vaccine Trials and the Black Community
Warren, R. C., Forrow, L., Hodge, D. A., & Truog, R. D. (2020) · New England Journal of Medicine · doi:10.1056/nejmp2030033 · Cited by 235 · see citing works
The ethics of placebo-controlled trials: Methodological justifications
Millum, J., & Grady, C. (2013) · Contemporary Clinical Trials · doi:10.1016/j.cct.2013.09.003 · Cited by 155 · see citing works
Self-citationWill covid-19 vaccines save lives? Current trials aren’t designed to tell us
Doshi, P. (2020) · BMJ · doi:10.1136/bmj.m4037 · Cited by 150 · see citing works
Is the concept of clinical equipoise still relevant to research?
Hey, S. P., London, A. J., Weijer, C., et al. (2017) · BMJ · doi:10.1136/bmj.j5787 · Cited by 48 · see citing works
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Research works printed but not linked: 2
- [4]Pfizer, “ Pfizer and BioNTech announce vaccine candidate against COVID-19 achieved success in first interim analysis from phase 3 study,” 9 November 2020; www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidateagainst.
- [10]Council for International Organizations of Medical Sciences (CIOMS), “ International ethical guidelines for health-related research involving humans” (Report, CIOMS, 2016); https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf. 40523065
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Immunological mechanisms of vaccine-induced protection against COVID-19 in humans
Sadarangani, M., Marchant, A., & Kollmann, T. R. (2021) · Nature Reviews Immunology · doi:10.1038/s41577-021-00578-z · Cited by 560 · see citing works
- Authors
- Wendler, D., Ochoa, J., Millum, J., Grady, C., & Taylor, H. A.
- Affiliations
- National Institutes of Health (US)
- Venue
- Science
- Published
- 2020-12-11
- Volume
- 370
- Issue
- 6522
- Pages
- 1277-1279
- ISSN
- 0036-8075 (ISSN-L)
- 1095-9203
- PMC
- PMC10107693
- OpenAlex
- W3110074024
- Cited by
- 50
- References
- 5
- Citations by year
- 2026: 1 · 2024: 2 · 2023: 4 · 2022: 9 · 2021: 32 · 2020: 2
- FWCI
- 8.80
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Science (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- PhilPapers (PhilPapers Foundation) (submittedVersion)
- Funders
- U.S. Department of Health and Human Services
- National Institutes of Health (Z99CL999999)
- U.S. Public Health Service
- NIH Clinical Center
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Keywords
- COVID-19 vaccines, vaccine efficacy, vaccine safety
- MeSH terms
- COVID-19 Vaccines, Humans, Placebos, United States, United States Food and Drug Administration, Drug Approval, Risk Assessment, Controlled Clinical Trials as Topic, Healthy Volunteers
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