高端疫苗二期收案3700人 預計下周開打 - 股票
By Frederic
at 2021-01-06T19:51
at 2021-01-06T19:51
Table of Contents
1.原文連結:
https://bit.ly/3pY8hVp
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2.原文內容:
高端疫苗二期收案3700人 預計下周開打
國內三家疫苗廠全力拼新冠肺炎疫苗,但目前僅有高端疫苗於去年12月29日通過衛福部食藥
署審核,將啟動臨床第二期計畫。高端疫苗總經理陳燦堅表示,將於台大醫院、北榮、中國
附醫、高醫等11間醫院執行臨床試驗,收案3700人,預計下周開始施打。
第二期臨床試驗執行總計畫主持人、台大醫院感染科主治醫師謝思民表示,在第一期臨床試
驗中,收案的45位受試者均沒有出現與疫苗相關嚴重不良反應,也沒有任何受試者出現發燒
症狀。在劑量上,中、高劑量的免疫生成性好,食藥署選定中劑量作為第二期的試驗劑量。
因此,第二期臨床試驗將確認中劑量在大規模的人體試驗中安全性和免疫生成性,計畫將採
雙盲方式,疫苗組將收3000人、安慰劑對照組500人,並將確認生產的批次間一致性。
謝思民表示,第二期臨床試驗計劃將分為20至64歲以及65歲以上兩個年齡組,針對健康民眾
以及控制良好的慢性病患進行施打。
目前總計劃已通過人體試驗委員會(IRB)審核,各醫學中心待申請完各醫院的IRB即可開始
收案、施打疫苗,最快將於下周開始施打。
其中,北榮預計收案800人,65歲以上長者將占兩成;北醫預計收案800人,65歲以上長者將
占100多人;中國附醫則預計收案500人。
高端總經理陳燦堅說,在多個臨床試驗中心同步進行收案,希望可縮短整體試驗執行時間,
目標於五月完成臨床試驗,第二季便可提出緊急使用授權(EUA)申請上市。
3.心得/評論:
※必需填寫滿20字
高端想要趕進度耶...
5月完成二期
Q2就緊急授權
國光聯亞還在幹嘛@@
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