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

Vaccine. 2022 Mar 25;40(14):2140-2149. doi: 10.1016/j.vaccine.2022.02.038. Epub 2022 Feb 28.

Authors

Jerome Amir Singh¹, Sonali Kochhar², Jonathan Wolff³, Caesar Atuire⁴, Anant Bhan⁵, Ezekiel Emanuel⁶, Ruth Faden⁷, Prakash Ghimire⁸, Dirceu Greco⁹, Calvin Ho¹⁰, Suerie Moon¹¹, Ehsan Shamsi-Gooshki¹², Aissatou Touré¹³, Beatriz Thomé¹⁴, Maxwell J Smith¹⁵, Ross E G Upshur¹⁶

Affiliations

¹ Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa; Scientific Advisory Group on Emergencies (SAGE), Academy of Science of South Africa (ASSAf), Pretoria, South Africa; Department of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada. Electronic address: singhj9@ukzn.ac.za.
² Department of Global Health, University of Washington, Seattle, WA, USA; Global Healthcare Consulting, Delhi, India.
³ Blavatnik School of Government, University of Oxford, Oxford, UK.
⁴ Department of Philosophy and Classics, University of Ghana, Accra, Ghana.
⁵ Department of Community Medicine and Centre for Ethics, Yenepoya University, Mangalore, India.
⁶ Global Initiatives and Healthcare Transformation Institute, University of Pennsylvania, Philadelphia, PA, USA.
⁷ Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
⁸ Tribhuvan University, Kirtipur, Nepal.
⁹ School of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil.
¹⁰ Faculty of Law and Centre for Medical Ethics, University of Hong Kong, Hong Kong Special Administrative Region, China.
¹¹ International Relations and Political Science Department & Interdisciplinary Programmes, Global Health Centre, Graduate Institute of International and Development Studies, Geneva, Switzerland.
¹² Department of Medical Ethics, Tehran University of Medical Sciences, Tehran, Iran.
¹³ Institut Pasteur, Dakar, Senegal.
¹⁴ Departamento de Medicina Preventiva, Universidade Federal de São Paulo, Rua Botucatu,Sao Paolo, Brazil.
¹⁵ Faculty of Health Sciences, Western University, London, Ontario, Canada.
¹⁶ Department of Family and Community Medicine and Dalla Lana School of Public Health University of Toronto, Toronto, Ontario, Canada.

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.

Keywords: Placebo-controlled trials; Research ethics; Standard of care; Standard of prevention; Trial designs.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

COVID-19 Vaccines
COVID-19* / prevention & control
Humans
SARS-CoV-2
Vaccines*
World Health Organization

Substances

COVID-19 Vaccines
Vaccines

Grants and funding

WT_/Wellcome Trust/United Kingdom