2015年1月27日讯/生物谷BIOON/--FDA近日批准了诺华的疫苗Bexsero，该疫苗用于预防由血清群B型脑膜炎球菌引发的脑膜炎，这是过去三个月内第二支获批的脑膜炎疫苗。
10月底，辉瑞的Trumenba获批，这是第一支获批的预防血清B型脑膜炎双球菌流脑的疫苗，诺华的Bexsero获批紧随其后。FDA表示，在此之前美国只有针对四种不同血清群的脑膜炎双球菌的疫苗，这四种脑膜炎球菌分别引发A型、C型、Y型和W型流脑，而脑膜炎双球菌的分型一共有5种，在此之前唯独血清群B型的脑膜炎球菌没有对应的疫苗。此番辉瑞和诺华的两支疫苗获批，算是弥补了这一缺憾。
据报道，2012年美国共有500例流脑患者，而其中160例都是感染了血清群B型脑膜炎双球菌。FDA的生物制品评估与研究中心主任Karen Midthun表示，这两支疫苗先后获批标志着流脑预防的主要工作基本完成。
FDA对Bexsero采取了加速批准政策，并且也授予Bexsero突破性治疗的称号，据悉，Bexsero也已在欧洲获批。
原文 FDA gives green light to Novartis vaccine Bexsero
The US Food and Drug Administration has approved the second vaccine in three months for the prevention of serogroup B meningococcal disease - Novartis’ Bexsero.
The thumbs-up for Bexsero comes after the agency approved Pfizer’s Trumenba at the end of October， making it the first vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B. The FDA noted that before these approvals， meningococcal vaccines in the USA covered only four of the five main serogroups of N. meningitidis bacteria that cause the disease： A， C， Y and W.
About 500 total cases of meningococcal disease were reported in the USA in 2012， of which 160 were caused by serogroup B and Karen Midthun， director of the FDA’s Center for Biologics Evaluation and Research， said the vaccines “represent a major public health accomplishment toward preventing this life-threatening disease”.
The FDA used the accelerated approval pathway to approve Bexsero， which was granted breakthrough therapy status. It is already approved in Europe.