对抗4种流感病毒株的疫苗获得批准

圣路易斯(MD Consult)——2012年12月17日，葛兰素史克宣布美国食品药品管理局(FDA)已经批准了Fluarix 四价疫苗(流感病毒疫苗)用于儿童(3岁或以上)和成人接种，以预防该疫苗含有的甲型和乙型季节性流感病毒所致疾病。Fluarix四价疫苗是首个含有4种流感病毒株的肌肉注射疫苗。

在Fluarix四价疫苗临床试验中，成人最常见不良发应是注射部位疼痛、肌痛、头痛和乏力，3~18岁儿童最常见不良发应是注射部位疼痛、发红和肿胀，3~6岁儿童最常见不良发应是困倦、烦躁和食欲下降。6~18岁儿童最常见全身不良反应是乏力、肌痛、头痛、关节痛和胃肠道症状。

葛兰素史克将在2013~14流感季节上市Fluarix四价疫苗。

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ST LOUIS (MD Consult) - On December 17, 2012, GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has approved Fluarix quadrivalent (influenza virus vaccine) for the immunization of children (aged 3 years anad older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine. Fluarix quadrivalent is the first intramuscular vaccine to provide coverage against 4 influenza strains.

In clinical trials with Fluarix quadrivalent, the most common adverse reactions in adults were pain at the injection site, myalgia, headaches, and fatigue. In children between the ages of 3 and 18 years, the most common adverse reactions were pain at the injection site, redness, and swelling. In children between the ages of 3 and 6 years, the most common adverse reactions were drowsiness, irritability, and loss of appetite. In children between the ages of 6 and 18 years, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia and gastrointestinal symptoms.

GlaxoSmithKline will make Fluarix quadrivalent available in time for the 2013-14 influenza season.