2026年2月19日消息,莫德纳采用mRNA技术的流感疫苗上市申请已获FDA受理,审批截止日期为2026年8月1日。此前FDA曾以临床试验设计存在缺陷为由拒绝受理,后改变立场同意审核。为加速获批,莫德纳提出分年龄段监管路径,为50至64岁人群寻求常规批准,为65岁及以上人群寻求加速批准,并承诺在老年人群中开展追加研究。若顺利获批,该疫苗计划于2026年晚些时候的流感季面向老年人群使用。以上内容基于...
Source Link2026年2月19日消息,莫德纳采用mRNA技术的流感疫苗上市申请已获FDA受理,审批截止日期为2026年8月1日。此前FDA曾以临床试验设计存在缺陷为由拒绝受理,后改变立场同意审核。为加速获批,莫德纳提出分年龄段监管路径,为50至64岁人群寻求常规批准,为65岁及以上人群寻求加速批准,并承诺在老年人群中开展追加研究。若顺利获批,该疫苗计划于2026年晚些时候的流感季面向老年人群使用。以上内容基于...
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