復星醫藥(02196.HK):BioNTech確認210102批次疫苗安全性和有效性不受影響 將繼續配合港澳疫苗接種計劃
格隆匯4月1日丨復星醫藥(02196.HK)發佈公吿,根據BioNTech截至目前針對210102批次的疫苗產品中存在少量西林瓶封蓋有關瑕疵問題的調查,BioNTech確認該問題的出現與超低温運輸條件下的疫苗包裝有關,疫苗的安全性和有效性不受到影響。
測試及對比的結果顯示,當產品在超低温儲存環境(即攝氏負70度)下儲存及運輸時,若軋蓋密封不夠緊,可能會導致空氣滲入瓶中,而其後進行解凍程序時膠塞重新恢復密封,可能會使瓶內壓力上升,因而發生個別藥瓶超壓或出現滲漏等情況。在同一場地灌裝的210104批次也有個別產品出現此類問題。
經詳細分析檢測和隨機抽樣測試,BioNTech認為沒有證據顯示210102及210104批次的疫苗存在安全風險;由於疫苗儲存於超低温環境,因此受到細菌污染的風險很低;即使藥瓶出現上述問題,有關疫苗的信使核糖核酸及脂質納米顆粒的完整性亦不會受到影響。基於上述結果,BioNTech認為疫苗的安全性及有效性未因前述問題而受到影響。
為謹慎起見,在最終調查報吿完成前,210102及210104兩個批次的疫苗將繼續封存。
集團及BioNTech將繼續配合香港及澳門政府疫苗接種計劃,保障疫苗的供應。預計近期將有一批由BioNTech位於德國的另一生產場地灌裝的疫苗產品運抵香港,用於香港及澳門的後續接種安排。
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