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默克的埃博拉疫苗V920获得了FDA的优先审查

2019-09-18 不详 MedSci原创

默克宣布FDA已接受其用于预防埃博拉扎伊尔病毒的研究性埃博拉疫苗V920的营销申请。FDA将对该疫苗进行优先审查评估,并在明年3月14日之前作出决定。

默克宣布FDA已接受其用于预防埃博拉扎伊尔病毒的研究性埃博拉疫苗V920的营销申请。FDA将对该疫苗进行优先审查评估,并在明年3月14日之前作出决定。

2016年公布的结果表明,在几内亚进行的III期临床试验初步数据证明V920疫苗在预防埃博拉感染中可实现100%的功效。

默克还表示将增加V920疫苗的存量,以满足刚果民主共和国和邻国正在进行的埃博拉疫情的需求。该制药商指出,自2018年5月以来,根据世界卫生组织(WHO)的要求,该疫苗已经运送了超过245000个1毫升的疫苗,并且有超过190000剂库存可供运输。

V920之前获得了欧洲药品管理局颁发的FDA和PRIME指定的突破性治疗指定。该疫苗于2014 年获得 NewLink Genetics的许可。

原始出处:


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