食衛局局長認可復星/BioNTech新冠疫苗在香港作緊急使用
食物及衛生局局長今日(25日)根據《預防及控制疾病(使用疫苗)規例》(第599K章),認可復星醫藥/德國藥廠BioNTech的新冠疫苖(即Comirnaty COVID-19 mRNA Vaccine(BNT162b2)Concentrate for Dispersion for Injection)在香港作緊急使用。
根據疫苗供應商提供的資料,準備供港的首批約100萬劑復星醫藥/德國藥廠BioNTech疫苗已經完成生產程序,並在進行安全和品質測試。視乎有關測試順利完成和通過,有關疫苗預計可於2月下旬由德國運抵香港。政府會在接收到有關疫苗並完成必須的質檢程序後,盡快啟動由政府主導的全港性疫苗接種計劃。政府會同時繼續積極跟進其餘本港已採購疫苗的緊急使用批核和供應時間表,並做好相關疫苗接種安排的籌備工作。政府亦會繼續按照疫苗採購策略,預先採購其他能夠符合安全、效能及質素要求包括仍在研發階段的新冠疫苗,以確保全港市民能有不同疫苗及足夠供應可供接種。
根據《規例》,食物及衛生局局長可在參考2019冠狀病毒病疫苗顧問專家委員會的意見後,認可符合安全、效能及質素要求的新冠疫苗在香港於緊急情況下作指明目的,基本上指由政府推行的疫苗接種計劃。顧問專家委員會已向食物及衛生局局長提交建議,認為在現時疫情情況下,認可使用復星醫藥/德國藥廠BioNTech的新冠疫苗作為預防2019冠狀病毒病的效益大於風險。
顧問專家委員會亦注意到一些海外國家,就接種復星醫藥/德國藥廠BioNTech疫苗後收到的懷疑不良情況的報告。根據有關當局公布的資料,疫苗一些常見的副作用,例如發燒或噁心,可能會對一些自身已有嚴重病患、身體尤其虛弱的人士有影響。衛生署已因應顧問專家委員會建議,要求疫苗供應商提供相關資料。衛生防護中心轄下的聯合科學委員會會審視相關資料,以助釐定接種該疫苗的優先組別須注意事項。
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