"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 Gooshkio, Aissatou Touré, Beatriz Thomé, Maxwell J.Smith, and Ross E.G.Upshur
Published on 28 February 2022
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.