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FDA批准2012-2013年流感季节疫苗

互联网2012年8月20日 10:05 点击：1621
一站式采购,来宝商城

CSL Limited法国赛诺菲巴斯德Sanofi Pasteur 瑞士诺华(Novartis)

英国葛兰素史克GSK GlaxoSmithKline美国MedImmune

美国食品和药物管理局8月13日宣布，它已批准2012-2013年流行性感冒（流感）疫苗配方，准许在美国的六个厂家生产和销售该疫苗。

每年来自FDA、世界卫生组织、疾病控制和预防中心（CDC）专家以及其他公共健康专家研究流感病毒样本和全球传染模式，以确定在即将到来的流感季节最有可能导致流感的病毒株。

依据数据和FDA疫苗及相关生物制品顾问委员会的建议，选定2012-2013年流感疫苗株为：

A/California/7/2009（H1N1）类病毒

A/Victoria/361/2011（H3N2）类病毒

B/Wisconsin/1/2010-类病毒。

虽然H1N1病毒是2011-2012年流感疫苗中包含的，但今年的H3N2流感病毒和B型流感病毒与2011-2012年流感疫苗的其他毒株不同。

据CDC预测，美国每年有5％-20％的人口将患流感。相关并发症导致的住院治疗将超过20万人。流感季节不可预测并且可能很严峻，在美国每年流感相关死亡人数在3000-1 49,000人之间。CDC免疫规范咨询委员会建议六个月的婴儿和老人应接种流感疫苗。

为即将到来的流感季节生产国家的2012-2013年流感疫苗的授权生产厂家及疫苗品牌为：

Afluria，CSL有限公司生产;

Fluarix，葛兰素史克生物制品生产;

FluLaval，ID生物医学公司生产;

FluMist，MedImmune的疫苗公司生产的;

Fluvirin，诺华疫苗和诊断公司生产;

Fluzone，Fluzone高剂量和Fluzone皮内注射，由赛诺菲巴斯德生产

 

FDA approves vaccines for the 2012-2013 influenza season

 
The U.S. Food and Drug Administration announced today that it has approved the 2012-2013 influenza (flu) vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the United States.
 
Each year experts from the FDA, the World Health Organization, the Centers for Disease Control and Prevention (CDC), and other public health experts study influenza virus samples and global disease patterns to identify virus strains likely to cause the most illness during the upcoming flu season.
 
Based on that information and the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the strains selected for inclusion in the 2012-2013 flu vaccines are:
  • A/California/7/2009 (H1N1)-like virus
  • A/Victoria/361/2011 (H3N2)-like virus
  • B/Wisconsin/1/2010-like virus.
 
While the H1N1 virus is the same as what was included in the 2011-2012 influenza vaccines, this year’s influenza H3N2 and B viruses differ from those in the 2011-2012 influenza vaccines.
Vaccination remains the cornerstone of preventing influenza, a contagious respiratory disease caused by different influenza viruses infecting the nose, throat and lungs. This year’s seasonal vaccines will provide protection against the three influenza virus strains that global surveillance indicates are likely to be the most common strains circulating during the upcoming season.
 
There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.
 
“The best way to prevent influenza is by getting vaccinated each year,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”
 
According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. This leads to more than 200,000 hospitalizations from related complications. Influenza seasons are unpredictable and can be severe, with annual influenza-related deaths ranging from a low of about 3,000 to a high of 49,000 people in the U.S. The CDC’s Advisory Committee on Immunization Practices, recommends that everyone six months of age and older receive an annual influenza vaccine.
 
Health care providers play an important role in advising their patients to get vaccinated each year and should also protect themselves, their patients, their family, and the community from influenza by getting vaccinated.  
 
The manufacturers licensed to produce the nation’s 2012-2013 flu vaccines and the brand names of the vaccines for the upcoming flu season are:
  • Afluria, manufactured by CSL Limited;
  • Fluarix, manufactured by GlaxoSmithKline Biologicals;
  • FluLaval, manufactured by ID Biomedical Corporation;
  • FluMist, manufactured by MedImmune Vaccines Inc.;
  • Fluvirin, manufactured by Novartis Vaccines and Diagnostics Limited; and
  • Fluzone, Fluzone High-Dose and Fluzone Intradermal, manufactured by Sanofi Pasteur.
（来源： 互联网 ）


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