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EMA委员会建议批准赛诺菲的登革病毒疫苗Dengvaxia

2018-10-21 MedSci MedSci原创

欧洲药品管理局(EMA)近日表示,其人用医药产品委员会(CHMP)建议批准赛诺菲的四价疫苗Dengvaxia,用于预防血清1、2、3和4型登革病毒引起的登革热。

欧洲药品管理局(EMA)近日表示,其人用医药产品委员会(CHMP)建议批准赛诺菲的四价疫苗Dengvaxia,用于预防血清1234型登革病毒引起的登革热。该疫苗预计将于12月份获得批准,EMA指出,Dengvaxia31临床研究中进行了测试,这些研究主要在登革热流行地区进行,包括拉丁美洲和亚太地区,超过41000名年龄在9个月至60岁的参与者接受至少一剂疫苗接种。总体数据显示,对于945岁从未患过登革热的人群,疫苗对预防登革热感染具有作用。Dengvaxia目前在20个国家获得了预防登革热的许可,包括墨西哥和巴西。

登革热是登革病毒经蚊媒传播引起的,登革病毒感染后可导致隐性感染、登革热、登革出血热。典型的登革热临床表现为头痛、高热、肌肉及骨关节剧烈酸痛、部分患者出现皮疹、出血倾向、淋巴结肿大、白细胞计数减少、血小板减少等。主要流行于热带和亚热带地区,包括我国广东、香港、澳门等地。由于经伊蚊传播,因此其流行有一定的季节性,一般在每年的511月份流行。


原始出处:

http://www.firstwordpharma.com/node/1598542#axzz5UXJIsme7

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    2019-02-24 spoonycyy
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    2018-10-23 fengyi812

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