世卫组织关于在已授权的 COVID-19 疫苗和扩大全球获取途径的背景下进行 COVID-19 疫苗试验设计的指南：伦理考虑。
WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations.
机构信息
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.
Department of Global Health, University of Washington, Seattle, WA, USA; Global Healthcare Consulting, Delhi, India.
出版信息
Vaccine. 2022 Mar 25;40(14):2140-2149. doi: 10.1016/j.vaccine.2022.02.038. Epub 2022 Feb 28.
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.
摘要
虽然 COVID-19 疫苗的可及性和接种率在国家和全球层面存在差异，但提高疫苗接种率引发了关于应在哪些不同环境中应用的预防标准的问题，这些环境中进行了 COVID-19 疫苗试验。世卫组织专家组制定了在扩大全球 COVID-19 疫苗覆盖范围的背景下进行安慰剂对照试验的伦理影响的指南。该指南还考虑了在原型疫苗、改良疫苗和新一代疫苗的背景下，替代安慰剂对照试验的试验设计。
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