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

Vaccine(2022)

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摘要
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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关键词
Placebo-controlled trials,Standard of care,Standard of prevention,Trial designs,Research ethics
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