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港府強調審批科興疫苗許可程序嚴謹
阿思達克 02-19 09:37
食物及衛生局回應有報道質疑審批科興疫苗獲准在港緊急使用的過程,指令人誤以為政府降低審批科興疫苗的標準,有關報道與事實不符。食衛局發言人表示,專家委員會曾就科興疫苗在港緊急使用申請舉行兩次會議,審視資料數據及政府審批許可的程序嚴謹、全面,符合所有《規例》下的相關要求,與審批「復必泰」疫苗在港緊急使用的程序並無二致。

就提交資料需在醫學期刊刊登的要求,發言人表示科興表示在短期內整理有關資料具相當難度,而科興已向衛生署提交向世衛及國家藥品監督管理局提供的資料,包括第一、二期的臨床測試資料、及在巴西、土耳其及印尼進行的第三期臨床測試資料,相關數據經顧問專家委員會檢視及評核,並參照世衛指引的相關要求,作仔細、客觀和全面評估,過程不遜於一貫學術期刊文章的同行評審。

發言人又指,世衛的審批並非本港認可疫苗作緊急使用的必要條件,科興疫苗已獲巴西、土耳其、印尼等規管機構,以及國家藥品監督管理局批准使用,以未獲世衛審批質疑疫苗審核作緊急使用過程,是出於對國際間審核疫苗作緊急使用的機制不理解。

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