复星医药(02196.HK)与BioNTech新冠候选疫苗 在中国开展II期临床试验
复星医药(02196.HK)与BioNTech公布,其mRNA新冠候选疫苗BNT162b2将在中国江苏泰州和涟水开展II期临床试验。
在中国进行的BNT162b2疫苗II期临床试验由江苏省疾控中心负责,试验将於泰州中国医药城疫苗工程中心和涟水县疾控中心进行。泰州市人民医院、涟水县人民医院等机构将会共同参与试验。计划於网上招募年龄介乎18至85岁的960名健康受试者,以评估该候选疫苗的安全性和免疫原性,用於支持未来在中国上市申请。
该疫苗正在进行的III期临床研究显示,BNT162b2已达到所有主要有效性终点,在预防COVID-19上的有效性达到95%,并收集了足够的安全数据,用以支持於2020年11月20日向美国食品药品监督管理局(FDA)提交的紧急使用授权(EUA)申请。此外,BNT162b2目前正在接受欧洲、英国和加拿大监管部门的监管审查。
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