高端新冠疫苗二期試驗進入尾聲 數據結果 - 股票
By Charlotte
at 2021-05-30T13:44
at 2021-05-30T13:44
Table of Contents
原文標題:高端新冠疫苗二期試驗進入尾聲 數據結果受矚
原文連結:https://news.cnyes.com/news/id/4653440
發布時間:鉅亨網記者沈筱禎 台北2021/05/30 11:12
原文內容:
台灣防疫遭逢危機,疫苗需求迫切,各界除積極向國際藥廠採購新冠疫苗外,時序進入第
2 季底,高端疫苗 (6547-TW) 執行的新冠疫苗二期臨床試驗也進入尾聲,部分疫苗已封
籤檢驗,依照進度來看,最慢 6 月上旬將公布臨床數據結果。
高端的新冠疫苗 MVC-COV1901,是與美國衛生研究院 (NIH) 合作開發,高端向 NIH 技轉
全長基因修飾重組 S-2P 蛋白作為疫苗抗原,篩選出候選疫苗免疫組合物,另外再採用美
國公司開發的佐劑。
高端新冠疫苗二期臨床試驗共 3700 名受試者,已在上 (4) 月底完成第二劑接種,依照
法規單位建議,於第二劑疫苗接種後第 28 天評估疫苗安全性與免疫原性,最快本月底、
6 月上旬有試驗分析結果。
高端已將數批新冠疫苗封籤檢驗,提供食藥署疫苗測試標準品,若數據達到預期目標,下
月將依法申請台灣緊急使用授權 (EUA),待取得認證後,最快 7 月開始供應。
至於外界關注的三期臨床試驗,高端提到,預計今年先申請緊急使用授權,現今緊急使用
授權是將二、三期試驗合併,但若未來新冠病毒變成流感化,後續也將執行三期臨床試驗
,並申請正規藥證,但由於目前法規尚不明朗,試驗設計仍在討論階段。
高端三期臨床試驗,初步擬朝三大方向進行,包括在高風險地區測出總體疫苗有效性
(VE)、與已上市新冠疫苗比較,以及遵循免疫相關保護指標 (ICP)。
心得/評論:
疫苗板的專業買進文,這不就來了
要上車的快上車,
不然別喊我還沒上車
對了~ 我們是不是快變高風險地區了呢??
--
防堵疫情 陳時中:6月底200萬劑疫苗將到貨 8月底累計千萬劑抵台
https://www.cna.com.tw/news/firstnews/202105255010.aspx
陳時中在答覆媒體詢問時表示,8月底累計到貨的1000萬劑,是包含國產疫苗在內。
--
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