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復星醫藥(02196.HK)與BioNTech新冠候選疫苗 在中國開展II期臨床試驗
阿思達克 11-25 16:58
復星醫藥(02196.HK)與BioNTech公布,其mRNA新冠候選疫苗BNT162b2將在中國江蘇泰州和漣水開展II期臨床試驗。

在中國進行的BNT162b2疫苗II期臨床試驗由江蘇省疾控中心負責,試驗將於泰州中國醫藥城疫苗工程中心和漣水縣疾控中心進行。泰州市人民醫院、漣水縣人民醫院等機構將會共同參與試驗。計劃於網上招募年齡介乎18至85歲的960名健康受試者,以評估該候選疫苗的安全性和免疫原性,用於支持未來在中國上市申請。

該疫苗正在進行的III期臨床研究顯示,BNT162b2已達到所有主要有效性終點,在預防COVID-19上的有效性達到95%,並收集了足夠的安全數據,用以支持於2020年11月20日向美國食品藥品監督管理局(FDA)提交的緊急使用授權(EUA)申請。此外,BNT162b2目前正在接受歐洲、英國和加拿大監管部門的監管審查。

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