摘要
2019冠状病毒病(Coronavirus disease 2019,COVID-19)全球大流行严重威胁公众健康,各国研究人员加速研发安全有效的COVID-19疫苗以应对全球COVID-19疫情。如何在特殊和紧急状态下在符合伦理要求框架中加快疫苗临床试验并科学地决策疫苗使用,是COVID-19疫苗研发和使用中面临的难题。本文系统地梳理了在特殊和紧急状态下COVID-19疫苗临床试验、审批和上市应用过程中需要解决的伦理问题。
The coronavirus disease 2019(COVID-19)pandemic is a serious public health threat.In response to the pandemic,researchers around the world are working to develop safe and effective COVID-19 vaccines.Accelerating vaccine development and clinical-trial evaluations,and determining scientifically sound strategies and policies for using the vaccines in special and emergency conditions require a strong ethical framework.In this article,we systematically outline ethical issues that need to be considered in clinical trials,regulatory approval,and evidencebased use of COVID-19 vaccines in special and emergency situations.
作者
雷红
郑徽
曹玲生
Lei Hong;Zheng Hui;Cao Lingsheng(National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China)
出处
《中国疫苗和免疫》
北大核心
2020年第5期597-601,共5页
Chinese Journal of Vaccines and Immunization
基金
国家科技重大专项“疫苗临床评价技术平台建设”课题(2018ZX09734004)。
