港府强调审批科兴疫苗许可程序严谨
食物及卫生局回应有报道质疑审批科兴疫苗获准在港紧急使用的过程,指令人误以为政府降低审批科兴疫苗的标准,有关报道与事实不符。食卫局发言人表示,专家委员会曾就科兴疫苗在港紧急使用申请举行两次会议,审视资料数据及政府审批许可的程序严谨、全面,符合所有《规例》下的相关要求,与审批「复必泰」疫苗在港紧急使用的程序并无二致。
就提交资料需在医学期刊刊登的要求,发言人表示科兴表示在短期内整理有关资料具相当难度,而科兴已向卫生署提交向世卫及国家药品监督管理局提供的资料,包括第一、二期的临床测试资料、及在巴西、土耳其及印尼进行的第三期临床测试资料,相关数据经顾问专家委员会检视及评核,并参照世卫指引的相关要求,作仔细、客观和全面评估,过程不逊於一贯学术期刊文章的同行评审。
发言人又指,世卫的审批并非本港认可疫苗作紧急使用的必要条件,科兴疫苗已获巴西、土耳其、印尼等规管机构,以及国家药品监督管理局批准使用,以未获世卫审批质疑疫苗审核作紧急使用过程,是出於对国际间审核疫苗作紧急使用的机制不理解。
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