美国下一季流感疫苗已通过审批

美国食品药品管理局(FDA)宣布，针对2012~13流感季节的疫苗已通过审批。

该疫苗中包含3个病毒株，除了同样包含在2011~2012流感季节疫苗中的甲型/加利福尼亚/7/2009(H1N1)样病毒之外，还纳入了2个新的病毒株：甲型/维多利亚361/2011(H3N2)样病毒和乙型/威斯康辛/1/2010样病毒。
 
FDA生物制剂评估与研究中心主管Karen Midthun博士在8月13日的声明中说：“尤其重要的是，需要在今年内完成接种，因为这一疫苗所含的3个病毒株中有2个与去年的疫苗不同。”

美国有6家厂商具有生产和销售流感疫苗的资质。经过核准的产品为Afluria(CSL有限公司)、Fluarix(葛兰素史克生物制品公司)、FluLaval(ID生物医学公司)、FluMist(MedImmune疫苗公司)、Fluvirin(诺华疫苗和诊断用品有限公司)，以及Fluzone、大剂量Fluzone和皮内注射用Fluzone(赛诺菲-巴斯德公司)。

每年流感疫苗中所含病毒株的选择依据是前一个流感季节全球流行的流感病毒信息和FDA疫苗与相关生物制品顾问委员会的建议。

美国疾病预防控制中心的免疫实践顾问委员会建议每年对所有年龄≥6个月的个体接种流感疫苗。

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By: ELIZABETH MECHCATIE, Cardiology News Digital Network

The influenza vaccine for the 2012-13 season has been approved by the Food and Drug Administration, the agency has announced.

The three strains that are included are an A/California/7/2009 (H1N1)-like virus, which was included in the 2011-2012 influenza vaccine, and two new strains: an A/Victoria/361/2011 (H3N2)-like virus, and a B/Wisconsin/1/2010-like virus.

"It is especially important to get vaccinated this year because two of the three virus strains used in this season’s influenza vaccines differ from the strains included in last year’s vaccines," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 13 statement.

Six manufacturers are licensed to produce and distribute influenza vaccine in the United States. The approved products are Afluria (CSL Limited); Fluarix (GlaxoSmithKline Biologicals); FluLaval (ID Biomedical Corp.); FluMist (MedImmune Vaccines Inc.); Fluvirin (Novartis Vaccines and Diagnostics Limited); and Fluzone, Fluzone High-Dose, and Fluzone Intradermal (Sanofi Pasteur).

Each year, the selection of strains to be included in the influenza vaccine is based on information about influenza virus circulating worldwide during the previous season and on recommendations from the FDA’s Vaccines and Related Biological Products Advisory Committee.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends an annual influenza vaccine for everyone aged 6 months and older.