脑膜炎球菌疫苗已获准用于婴幼儿
四价共轭脑膜炎球菌疫苗Menveo的生产商诺华公司宣布,该疫苗目前已被批准用于年龄低至2个月的儿童。
此前,Menveo(A、C、W-135和Y群脑膜炎球菌共轭疫苗)已获准用于年龄2~55岁的儿童和成人。该疫苗最初于2010年2月在美国上市,获准用于年龄11~55岁的青少年和成人;2011年1月,其适用年龄范围扩大至2~55岁。该疫苗的适应证为预防由4种脑膜炎奈瑟氏菌株引起的脑膜炎球菌疾病。
诺华公司在声明中称,本次批准令的依据是3项研究的结果,这些研究涉及来自美国、澳大利亚、加拿大、拉丁美洲和台湾地区的8,700多名婴幼儿。
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By: ELIZABETH MECHCATIE, Clinical Neurology News Digital Network
The quadrivalent conjugate meningococcal vaccine Menveo is now licensed for use in children down to age 2 months, according to Novartis, the manufacturer.
Previously, Menveo (meningococcal group A, C, W-135 and Y conjugate vaccine) was licensed for children and adults aged 2-55 years. It was initially licensed in the United States in February 2010 for adolescents and adults aged 11-55 years, and the age was expanded down in January 2011. It is indicated for the prevention of meningococcal disease caused by four strains of the bacterium Neisseria meningitidis.
The approval was based on the results of three studies involving more than 8,700 infants in the United States, Australia, Canada, Latin America, and Taiwan, according to the statement from Novartis announcing the approval.
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