美國FDA之新冠肺炎新疫苗研發指引──兼論臺灣新冠肺炎疫苗【本期企劃】 試閱
US FDA Guidance on the Development of COVID-19 Vaccine and Some Issues Regarding Domestic Vaccine Development
美國食品藥物管理署於2020年6月發布新冠肺炎新疫苗之研發與發證指引，詳述法規單位的觀點，是研發疫苗的重要參考資料。目前國際上有八支候選疫苗已經或即將進入第三期臨床試驗，其試驗規劃基本上均符合指引的考量。本文將簡介指引中的特殊考量，並據以探討臺灣新冠肺炎疫苗研發的若干問題。
US Food and Drug Administration issued Guidance for Industry titled Development and Licensure of Vaccines to Prevent COVID-19 in June 2020. The guidance describes the Agency’s thinking and is the most importance reference regarding anti-COVID-19 vaccines development. There are 8 candidate vaccines have moved or moving into phase III clinical trial. Study designs of all of the trials are comparable with the considerations in guidance. This article is to introduce the special considerations in the guidance, and then to address some issues regarding domestic anti- COVID-19 vaccines development.
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