我国疫苗安全保障系统的完善——基于上市后安全风险监测视角

随着系列疫苗安全事件相继曝出,疫苗的安全问题被推到舆论的风口浪尖,反映出我国疫苗安全监管体系中尚存在漏洞.本文对山西、山东2次疫苗案件的发生原因和暴露出的问题进行深层剖析,指出我国在疫苗上市后安全风险监测中存在的问题,并通过对美国被动、主动监测疫苗上市后安全风险方式的梳理,基于上市后安全风险监测视角,从预防、预警、应急处置三方面提出完善我国疫苗安全保障系统的具体建议.

Improvement of vaccine safety guarantee system in China-based on post-marketing surveillance of vaccine safety

Vaccine safety has been attracted more attentions owing to a series of vaccine safety events,which revealed serious problems existed in supervision system in China.Based on analysis of the causes and problems of two vaccine cases occurred in Shanxi and Shandong,this paper points out the problems existed in post-marketing surveillance of vaccine safety.After analysis of passive and active surveillances of post-marketing vaccine safety in America,this paper also gives a suggestion for improving the vaccine safety system in China from three aspects of prevention,early warning and emergency response.