国内外疫苗风险效益评估评价方法进展  

Research Progress in Methods of Risk&Benefit Assessment of Vaccines

作　　者：刘春光[1] 梁龚山 许长青[1] LIU Chunguang;LIANG Gongshan;XU Changqing(Department of Pharmacy,Beijing Corps Hospital of Chinese People’s Armed Police Force,Beijing 100027,China)

机构地区：[1]武警北京总队医院,北京100027

出　　处：《中国药物警戒》2021年第11期1097-1100,共4页Chinese Journal of Pharmacovigilance

摘　　要：疫苗的风险效益评估方式已经成为监管机构和疫苗企业评价疫苗的重要决策工具,目前国外疫苗风险效益评估方法处于起步阶段,没有统一模式,质量调整生命年法和多准则决策分析法理论及应用较多,世界卫生组织(WHO)制定了医疗产品国家监管体系评估全球基准工具用来评估疫苗国家监管体系,其中包括疫苗的风险效益评估工作相关要求。我国应逐步建立并完善疫苗风险效益评估方法,同时需要监管机构、公共卫生机构、疫苗生产企业共建共享数据平台,提供更多证据,促进疫苗评价工作,完善我国疫苗监管体系。T he way i n which t he r isk&benefit of vaccines a re assessed has become a n i mportant means by which regulators and vaccine manufactures assess vaccines.Currently,foreign methods of assessment of the risk&benefit of vaccines are not yet full-fledged and there are no universally-used ones.The methods of quality-adjusted life years and multi-criteria decision-making method were prevalent.the World Health Organization(WHO)developed the Global Benchmark Tool for the national regulatory system for medical products to assess national regulatory systems for vaccines,including requirements related to the risk&benefit assessment of vaccines.China is to gradually establish and improve methods of assessment of the risk&benefit vaccines.Meanwhile,regulatory authorities,public health institutions and vaccine manufacturers should build a shared data platform to provide more evidence,promote vaccine assessment and improve China’s vaccine regulatory systems.

关 键 词：疫苗 风险效益评估 质量调整生命年 多准则决策分析 

分 类 号：R186[医药卫生—流行病学]