默克公司的埃博拉疫苗Ervebo在四个非洲国家获得批准

2020-02-20 不详 MedSci原创

默克公司的埃博拉疫苗Ervebo已在四个非洲国家(包括受该病影响最严重的国家--刚果民主共和国)获得批准。去年,默克公司成为第一个获得美国食品药品监督管理局和欧洲药品管理局批准的埃博拉疫苗的药物开发商。

默克公司的埃博拉疫苗Ervebo已在四个非洲国家(包括受该病影响最严重的国家--刚果民主共和国)获得批准。去年,默克公司成为第一个获得美国食品药品监督管理局和欧洲药品管理局批准的埃博拉疫苗的药物开发商。

现在,Ervebo已在刚果民主共和国、布隆迪、加纳和赞比亚的国家卫生部门注册。该制药公司还表示,希望不久的将来在非洲其他国家获得批准。

默克公司表示将启动授权剂量的生产,预计这些剂量将在2020年第三季度左右提供。

在2014-2016年西非爆发的高峰期,2015年在几内亚的一项重大试验中对Ervebo进行了研究,涉及11841人。

在接受疫苗的5837人中,接种疫苗十天或更长时间后未记录到埃博拉病毒病例,而安慰剂组接种疫苗十天或更长时间后有23例感染。

迄今为止最严重的埃博拉疫情(在西非)导致28600例病例,超过11000例死亡,由于危机的紧迫性,许多大型制药公司开始开发疫苗来应对这种疾病。

自2018年8月1日爆发以来,刚果(金)目前正在爆发埃博拉疫情,超过2200人丧生,已确诊3300例感染

除默克公司外,强生公司还向EMA提交了埃博拉疫苗的上市授权申请,该疫苗包括Ad26.ZEBOV和MVA-BN-Filo 两种方案。

原始出处:


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    2020-04-13 chenwq08
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