國藥中生稱新冠疫苗接種試驗抗體陽轉率達100% 最快年底上市
國藥中國生物公司宣布,6月16日,國藥中國生物武漢生物製品研究所研製的新冠病毒滅活疫苗Ⅰ/Ⅱ期臨床試驗盲態審核暨階段性揭盲會在北京、河南兩地同步舉行。截至目前,Ⅰ/Ⅱ期臨床研究受試者共1,120人,已全部完成2針次接種。結果顯示,疫苗接種後安全、有效,接種疫苗組受試者均產生高滴度抗體,18-59歲組中劑量按照0,14天和0,21天程序接種兩劑後中和抗體陽轉率達97.6%,按照0,28天程序接種兩劑中和抗體陽轉率達100%。
據《中國證券報》獲悉,疫苗的臨床試驗分為三期,完成I-III期臨床直至上市,預計最快需要到今年底或明年初。
國藥中國生物指,中國生物積極推進Ⅲ期臨床的海外合作,與多個國家的企業及機構確定了合作意向。中國生物已率先建成了高生物安全等級生產車間,這也是目前全球唯一符合生物安全和GMP標准、從數量上能夠滿足緊急接種需求的新冠疫苗生產車間。
公司表示目前疫情防控形勢仍然復雜嚴峻,通過疫苗預防和控制新冠疫情迫在眉睫。此次揭盲的安全性、有效性數據,極大增強了各方贏得疫情防控阻擊戰最終勝利的信心,同時也為實現新冠疫苗作為全球公共產品的可及性和可負擔性,提供有力支撐,做出中國貢獻。
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