蜱传脑炎疫苗TicoVac,已获得美国FDA的优先审查

2021-02-24 Allan MedSci原创

辉瑞公司今天宣布,美国FDA接受了针对TicoVac的生物制剂许可申请(BLA)的优先审查,该疫苗旨在预防1岁及以上个体的蜱传脑炎(TBE)。

辉瑞公司今天宣布,美国FDA接受了针对TicoVac的生物制剂许可申请(BLA)的优先审查,该疫苗旨在预防1岁及以上个体的蜱传脑炎(TBE)。

蜱传脑炎(TBE)是由蜱传脑炎病毒引起的,以中枢神经系统病变为主要特征,病死率高达10%~20%,是近年来病毒学专家研究的重点和难点。迄今为止,在欧洲和亚洲超过35个国家/地区已发现TBE病例。欧洲疾病预防控制中心(ECDC)建议对居住在或正在前往这些危险地区的人群接种TBE疫苗。

辉瑞公司疫苗全球总裁Nanette Cocero博士说:“多年来,我们的TBE疫苗已保护了数百万欧洲人免于这种严重疾病侵害。如果TicoVac在美国获得批准,我们希望这种疫苗将有助于保护那些前往或暂时居住在高风险地点的人群”。

在临床试验中,TicoVac的安全性和免疫原性在两个年龄段人群(1-15岁和16-65岁)中得到了评估。在这些研究中,1-15岁人群血清阳性率为99-100%,> 15岁的成年人为94-99%。临床研究表明,TicoVac具有良好的耐受性,没有观察到的不良事件或与疫苗相关的严重不良事件。随后的真实世界研究表明,该疫苗在至少接受过两剂疫苗的人群中的有效率为96-99%,足以提供持久的免疫记忆。

 

原始出处:

https://www.firstwordpharma.com/node/1803503?tsid=4

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    2021-02-26 仁医06

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