“预防接种异常反应”定义辨析

Critical Analysis on the Definitions of Adverse Events Following Immunization

虽然预防接种异常反应发生的概率极低,但一旦发生,却常常产生较大的负面社会影响,逐渐成为社会普遍关心的问题。本文对有关预防接种负性事件的几个重要定义进行了辨析,包括世界卫生组织(WHO)的定义,我国"预防接种异常反应"法律定义和"疑似预防接种异常反应"监测定义。发现我国疑似预防接种异常反应中文名称与英文译名不符,名词之间容易混淆。预防接种异常反应的定义造成在寻求证据和因果关系判定方面存在实际操作困难,需要修改法律定义以放宽证据把握尺度,并借鉴美国"疫苗伤害表"简化因果关系判定标准。建议在更多实证研究获取证据基础上,采用WHO预防接种不良事件概念和定义,并采用无过错责任补偿原则替代《疫苗流通和预防接种管理条例》中对预防接种异常反应的严格法律定义。

＂Adverse events following immunization＂（ AEFI） refers to extremely rare events associated with immunization. Despite their rarity,AEFI events in China often have large negative social consequences. This research investigates three definitions of AEFI： the one adopted by the WHO,the one adopted by the Chinese juridical system,and the one adopted by the Chinese disease surveillance system. It is found that the Chinese term Suspected Rare Vaccine Reactions and its English translation（ AEFI） do not match. Further confusion is created by the disparities among Chinese terms,WHO term of AEFI and its Chinese translation. The legal definition of AEFI（ Rare Vaccine Reactions）,which is the standard used in compensation cases in China,is narrower and stricter than the no-fault compensation principle adopted by many countries. Chinese legal definition of AEFI causes operational difficulties in gathering evidence and determining causality. It is suggested that China should adopt the WHO recommended AEFI definition in surveillance,amend the legal definitionsto lessen the requirement for evidence,adopt the＂vaccine injury table＂method to simplify the causality criteria,and adopt the no fault compensation principle in legal cases,so that more equitable compensation outcomes may be created.