WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations

Jerome Amir Singh; Sonali Kochhar; Jonathan Wolff; Caesar Atuire; Anant Bhan; Ezekiel Emanuel; Ruth Faden; Prakash Ghimire; Dirceu Greco; Calvin Ho; Suerie Moon; Ehsan Shamsi-Gooshki; Aissatou Touré; Beatriz Thomé; Maxwell J. Smith; Ross E.G. Upshur

doi:10.1016/j.vaccine.2022.02.038

WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations

Jerome Amir Singh, Sonali Kochhar, Jonathan Wolff, Caesar Atuire, Anant Bhan, Ezekiel Emanuel, Ruth Faden, Prakash Ghimire, Dirceu Greco, Calvin Ho, Suerie Moon, Ehsan Shamsi-Gooshki, Aissatou Touré, Beatriz Thomé, Maxwell J. Smith, Ross E.G. Upshur

Department of Philosophy and Classics

Research output: Contribution to journal › Review article › peer-review

16 Citations (Scopus)

Abstract

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

Original language	English
Pages (from-to)	2140-2149
Number of pages	10
Journal	Vaccine
Volume	40
Issue number	14
DOIs	https://doi.org/10.1016/j.vaccine.2022.02.038
Publication status	Published - 25 Mar 2022

Keywords

Placebo-controlled trials
Research ethics
Standard of care
Standard of prevention
Trial designs

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.vaccine.2022.02.038

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Singh, J. A., Kochhar, S., Wolff, J., Atuire, C., Bhan, A., Emanuel, E., Faden, R., Ghimire, P., Greco, D., Ho, C., Moon, S., Shamsi-Gooshki, E., Touré, A., Thomé, B., Smith, M. J., & Upshur, R. E. G. (2022). WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations. Vaccine, 40(14), 2140-2149. https://doi.org/10.1016/j.vaccine.2022.02.038

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abstract = "While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.",

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doi = "10.1016/j.vaccine.2022.02.038",

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Singh, JA, Kochhar, S, Wolff, J, Atuire, C, Bhan, A, Emanuel, E, Faden, R, Ghimire, P, Greco, D, Ho, C, Moon, S, Shamsi-Gooshki, E, Touré, A, Thomé, B, Smith, MJ & Upshur, REG 2022, 'WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations', Vaccine, vol. 40, no. 14, pp. 2140-2149. https://doi.org/10.1016/j.vaccine.2022.02.038

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T2 - Ethical considerations

AU - Singh, Jerome Amir

AU - Kochhar, Sonali

AU - Wolff, Jonathan

AU - Atuire, Caesar

AU - Bhan, Anant

AU - Emanuel, Ezekiel

AU - Faden, Ruth

AU - Ghimire, Prakash

AU - Greco, Dirceu

AU - Ho, Calvin

AU - Moon, Suerie

AU - Shamsi-Gooshki, Ehsan

AU - Touré, Aissatou

AU - Thomé, Beatriz

AU - Smith, Maxwell J.

AU - Upshur, Ross E.G.

PY - 2022/3/25

Y1 - 2022/3/25

N2 - While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

AB - While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

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KW - Research ethics

KW - Standard of care

KW - Standard of prevention

KW - Trial designs

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M3 - Review article

C2 - 35248422

AN - SCOPUS:85125862029

SN - 0264-410X

VL - 40

SP - 2140

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JO - Vaccine

JF - Vaccine

IS - 14

ER -

WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations

Abstract

Keywords

UN SDGs

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