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019

 

 

國民黨發言人何志勇今日質疑,衛福部食藥署日前公布國產新冠肺炎疫苗緊急使用授權(EUA)審查標準,擬以
「免疫橋接」方式佐證,取代國際各大藥廠申請緊急授權所依據的第三期臨床試驗期中報告,並強調該審查標準是
根據美國食品藥物管理局(FDA)相關規定來制訂,但據今日報載FDA回函告知食藥署,「FDA仍在討論免疫橋接的
方法,目前不可能有官方立場」,無疑是狠打了執政黨的臉。

他強調,政府應該全力協助民間取得已經獲得國際認證的外國疫苗,而不是弄一個尚未有定論的「免疫橋接」,國
人健康不能被當白老鼠實驗。

何志勇表示,儘管國際間已開始就「免疫橋接」的可行性進行討論,但至今仍莫衷一是,當然也沒有任何國家採取
這種作法,既然蔡英文總統宣示過「一定用國際標準來審查」,如今的國際標準就是至少要做到第三期臨床試驗期
中報告,透過更多的樣本數來蒐集證據,以確保疫苗的效力。

何志勇說,蔡政府應切忌不該過度自我膨脹,把攸關全國人民生命健康安全的國產新冠疫苗研發也要「超前部署」
引領全球,這個不能和「外宣」操作等同視之,而是要講究科學證據。

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