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

University of KwaZulu-Natal
Academy of Science of South Africa
University of Toronto
University of Washington
Global Healthcare Consulting
Oxford University
Yenepoya University
University of Pennsylvania
Johns Hopkins University
Tribhuvan University
Universidade Federal de Minas Gerais
The University of Hong Kong
Graduate Institute of International and Development Studies
Tehran University of Medical Sciences
Institut Pasteur de Dakar
Universidade Federal de São Paulo
Western University
University of Toronto Faculty of Medicine

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

UN SDGs

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

SDG 3 Good Health and Well-being

Keywords

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

Access to Document

10.1016/j.vaccine.2022.02.038

Cite this

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

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AN - SCOPUS:85125862029

SN - 0264-410X

VL - 40

SP - 2140

EP - 2149

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

UN SDGs

Keywords

Access to Document

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