EUA疫苗注射後不良反應之因果關係認定與受害救濟【醫事法學教室】 試閱
COVID-19 EUA Vaccine Injury Compensation and Its Causality Assessment
雖然我國預防接種(疫苗)受害救濟制度於30餘年前便已建立,但是在COVID-19新冠肺炎全球大流行之下,政府基於疫情需求,允許藥廠跳過一般疫苗發展的完整臨床試驗與研究流程,可以提前申請緊急使用授權許可(EUA),如此之權宜做法是否會對此制度帶來衝擊?本文欲探討︰民眾接種EUA疫苗而發生疑似不良反應事件,是否同樣可以符合疫苗受害救濟的申請要件?其因果關係判定與一般正常流程上市許可的疫苗,是否會有不一樣的問題?國內論者經常提及的「解剖」是否為申請疫苗受害救濟之要件?
Since the COVID-19 pandemic started, many vaccines have been approved through Emergency Use Authorization (EUA) programs in the world. This article aims to explore whether the individuals who allege injury as a result of the administration of EUA vaccines are eligible to apply for benefits under the Vaccine Injury Compensation Program in Taiwan, and how the Program assesses the causal relationship between the injury and the vaccine. The role of pathological anatomy, often mentioned in the media report on vaccine injury cases, in the determination of causality will also be discussed.
121-128