卫生部宣布,药物管制局(PBKD)在周四召开的第375次会议,同意对莫德纳的Spikevax新冠疫苗给予有条件注册,供12岁及以上群体施打。
卫生总监丹斯里诺希山说,这款由西班牙制药厂Rovi Pharma Industrial Services生产的疫苗,此前已获准有条件注册,供18岁及以上群体使用。
他今日(4日)发文告说,药物管制局迄今已批准辉瑞及科兴疫苗供12岁及以上群体接种。
他说,这项有条件注册批准需要国家药剂监管机构(NPRA)不时根据最新数据,持续监督和评估该疫苗的品质、安全性及有效性资料,以确保该产品的利益风险比较(利益大于风险)维持正面。
“卫生部将继续提升人民获得治疗及防范冠病药物的机会,并确保根据品质、安全性及有效性等方面进行适当评估。”
(源自马新社)
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