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Influenza is an acute, highly communicable viral disease that affects the respiratory tract and is responsible for seasonal epidemics worldwide. Influenza A is the most prevalent type associated with widespread outbreaks and is subtyped based on two surface glycoproteins: hemagglutinin (H) and neuraminidase (N), as in H1N1. These glycoproteins are essential for viral infectivity, transmission, and immune recognition. Transmission occurs primarily through respiratory droplets and contaminated...
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在活体,适应感冒的,鼻内流感疫苗后报告的不良事件.

Hector S Izurieta1, Penina Haber, Robert P Wise

  • 1Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md 20852-1448, USA. hector.izurieta@fda.hhs.gov

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对三价活体减弱型流感疫苗 (LAIV-T) 的许可后监测没有发现意外的严重风险. 观察到过敏反应等罕见事件,并且在有过史的人群中出现了喘恶化.

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科学领域:

  • 疫苗学 疫苗学 疫苗学
  • 公共卫生监督 公共卫生监督
  • 免疫学 免疫学 免疫学

背景情况:

  • 美国食品和药物管理局在2003年6月批准了三价活体减弱型流感疫苗 (LAIV-T),用于5-49岁的健康个体的鼻入使用.
  • 许可前的试验不足以可靠地检测与LAIV-T相关的罕见不良事件.

研究的目的:

  • 识别和分析LAIV-T许可证后报告的不良事件.

主要方法:

  • 分析了在2003-2004年和2004-2005年流感季节向美国疫苗不良事件报告系统 (VAERS) 报告的不良事件.
  • 报告率是按每10万接种疫苗的人计算的.

主要成果:

  • 在许可证颁发后的前两个赛季,大约有250万个人接受了LAIV-T.
  • VAERS收到了460份报告;没有报告死亡事故. 罕见的事件包括过敏反应 (7),吉兰-巴雷综合征 (2),贝尔 (1) 和之前患有喘的人的喘恶化 (8).
  • 16%的报告是针对疫苗批准指示之外的个人.

结论:

  • 经过VAERS的许可后监测没有透露LAIV-T在按指示使用时存在意想不到的严重风险.
  • 过敏反应是一种罕见的潜在不良事件,与其他疫苗一致.
  • 在有喘病史的人群中喘恶化突显了遵守批准的疫苗标签的重要性.