ST LOUIS (MD Consult) - On December 23, 2009, the US Food and Drug Administration (FDA) approved Fluzone High-Dose, an inactivated influenza virus vaccine. The vaccine is indicated for use in persons aged 65 years and older for the prevention of disease caused by influenza virus subtypes A and B.
Fluzone High-Dose was approved via the FDA's accelerated approval pathway. In clinical studies in which the product was compared with Fluzone in older persons, Fluzone High-Dose promoted an enhanced immune response. The manufacturer (Sanofi Pasteur) is required to conduct further studies to verify that Fluzone High-Dose will decrease the occurrence of seasonal influenza disease after vaccination.
Each 0.5 mL dose of Fluzone High-Dose contains a total of 180 μg of influenza virus hemagglutinin (HA), which is composed of 60 μg of each of the 3 influenza virus strains. Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 μg of influenza virus HA (15 μg HA from each of the 3 influenza strains per dose).
As expected, because of the higher HA content, nonserious adverse events occurred more frequently after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness, and swelling at the injection site as well as headache, myalgia, fever, and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.
Persons with hypersensitivity to egg proteins or who have experienced life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.
Fluzone High-Dose is administered as a single injection in the upper arm and is available in single-dose prefilled syringes without preservative.
圣路易斯(MD Consult)—2009年12月23日，美国食品药品管理局(FDA)批准了Fluzone High-Dose—一种灭活的流感病毒疫苗。该疫苗适用于65岁以上的老年人预防A亚型和B亚型流感病毒所致的疾病。
Fluzone High-Dose经FDA的快速审批程序获得批准。临床研究结果显示，与Fluzone相比，Fluzone High-Dose可增强机体的免疫应答。FDA要求生产厂家(赛诺菲巴斯德公司)做进一步的研究，证实接种Fluzone High-Dose可降低季节性流感的发病率。
每0.5 ml 剂量的Fluzone High-Dose中包括3个流感病毒株，每个流感病毒株的血凝素(HA)含量为60 μg，故此剂共含有180 μg流感病毒HA。目前获准的其他成人季节性流感疫苗的流感病毒HA含量为45 μg (每剂有3个流感病毒株，每个病毒株的HA含量为15 μg)。
正如所料，由于Fluzone High-Dose的HA含量较高，故与Fluzone相比，接种该疫苗后的非严重不良事件的发生率较高。临床研究过程中常见的不良事件有注射部位疼痛、泛红和肿胀，以及头痛、肌痛、发热和全身不适等。Fluzone High-Dose与Fluzone的严重不良事件发生率相当。
对鸡蛋蛋白过敏者或在先前接种任何流感疫苗后曾发生危及生命的反应者均不应接种Fluzone High-Dose疫苗。
Fluzone High-Dose的接种方式为上臂单次注射，以无防腐剂的单剂预填充注射器形式出售。
