对四价人类乳头瘤病毒复合疫苗进行许可后安全监测
Barbara A Slade1, Laura Leidel, Claudia Vellozzi
1Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Mailstop D-26, Atlanta, GA 30333, USA. bfs9@cdc.gov
JAMA
|August 20, 2009
概括
与其他疫苗相比,四价人乳头瘤病毒疫苗 (qHPV) 没有增加不良事件发生率. 然而,数据挖掘揭示了失眠和静脉血栓栓塞事件的不成比例报告.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 公共卫生 公共卫生
背景情况:
- 四价人乳头瘤病毒 (qHPV) 疫苗于2006年在美国获得许可,适用于9-26岁的女性.
- 建议11-12岁的女孩进行常规的qHPV疫苗接种.
研究的目的:
- 为了总结免疫接种后的不良事件 (AEFI),在 qHPV 接收后向疫苗不良事件报告系统 (VAERS) 报告.
- 分析2006年6月至2008年12月的AEFI数据,包括许可前试验和公开报告的事件.
主要方法:
- 审查并描述了向VAERS报告的AEFI,这是一个被动监控系统.
- 使用统计数据挖掘,包括比例报告比率 (PRRs),以检测报告中的不成比例.
- 计算了每10万分发剂量报告率,并将其与背景报告率进行比较.
主要成果:
- 美国联邦医疗服务局收到了12424份AEFI报告 (每10万剂量中有53.9份).
- 严重的AEFI占报告的6.2%,其中包括32例死亡.
- 对 (8.2/100,000剂量) 和静脉血栓栓塞事件 (0.2/100,000剂量) 观察到不成比例的报告.
结论:
- 大多数qHPV AEFI率与其他疫苗的背景率相当.
- 失眠和静脉血栓栓塞事件的不成比例报告需要进一步关注.
- 必须考虑被动监控的局限性,包括潜在的报告不足.
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