复星医药(02196.HK)预计近期有一批疫苗运抵港澳用於後续接种安排
复星医药(02196.HK)公布,BioNTech至今就针对「210102」批次的疫苗产品中存在少量西林瓶封盖有关瑕疵问题的调查,BioNTech确认该问题的出现与超低温运输条件下的疫苗包装有关,疫苗的安全性和有效性不受到影响。
经详细分析检测数据和随机抽样测试,BioNTech认为没有证据显示新冠疫苗批次「210102」及「210104」 存在安全风险;由於疫苗储存於超低温环境,因此受到细菌污染的风险很低;即使药瓶出现问题,有关疫苗的信使核糖核酸(mRNA)及脂质纳米颗粒的完整性亦不会受到影响。基於上述结果,BioNTech认为疫苗的安全性及有效性并未受到影响。
为谨慎起见,在最终调查报告完成之前,「210102」及「210104」两个批次的疫苗仍将继续封存。
同时,集团与BioNTech将继续配合中国香港及澳门政府疫苗接种计划,保障疫苗的供应。预计近期将有一批由BioNTech位於德国的另一生产场地灌装的疫苗产品运抵香港,用於香港、澳门的後续接种安排。
根据测试及对比结果显示,当产品在超低温储存环境(即摄氏负70度)下储存及运输时,若轧盖密封不够紧,可能会导致空气渗入瓶中,而其後进行解冻程序时胶塞重新恢复密封,可能会使瓶内压力上升,因而发生个别药瓶超压或出现渗漏等情况。在同一场地灌装的210104批次也有个别产品出现此类问题。
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