Slade Barbara A, Leidel Laura, Vellozzi Claudia, Woo Emily Jane, Hua Wei, Sutherland Andrea, Izurieta Hector S, Ball Robert, Miller Nancy, Braun M Miles, Markowitz Lauri E, Iskander John
Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Mailstop D-26, Atlanta, GA 30333, USA.
JAMA. 2009 Aug 19;302(7):750-7. doi: 10.1001/jama.2009.1201.
In June 2006, the Food and Drug Administration licensed the quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine (qHPV) in the United States for use in females aged 9 to 26 years; the Advisory Committee on Immunization Practices then recommended qHPV for routine vaccination of girls aged 11 to 12 years.
To summarize reports to the Vaccine Adverse Event Reporting System (VAERS) following receipt of qHPV.
DESIGN, SETTING, AND PARTICIPANTS: Review and describe adverse events following immunization (AEFIs) reported to VAERS, a national, voluntary, passive surveillance system, from June 1, 2006, through December 31, 2008. Additional analyses were performed for some AEFIs in prelicensure trials, those of unusual severity, or those that had received public attention. Statistical data mining, including proportional reporting ratios (PRRs) and empirical Bayesian geometric mean methods, were used to detect disproportionality in reporting.
Numbers of reported AEFIs, reporting rates (reports per 100,000 doses of distributed vaccine or per person-years at risk), and comparisons with expected background rates.
VAERS received 12 424 reports of AEFIs following qHPV distribution, a rate of 53.9 reports per 100,000 doses distributed. A total of 772 reports (6.2% of all reports) described serious AEFIs, including 32 reports of death. The reporting rates per 100,000 qHPV doses distributed were 8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barré syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease. Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods.
Most of the AEFI rates were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events. The significance of these findings must be tempered with the limitations (possible underreporting) of a passive reporting system.
2006年6月，美国食品药品监督管理局批准了四价人乳头瘤病毒（6、11、16和18型）重组疫苗（qHPV）用于9至26岁的女性；免疫实践咨询委员会随后建议为11至12岁的女孩进行qHPV常规接种。
总结向疫苗不良事件报告系统（VAERS）报告的接种qHPV后的情况。
设计、地点和参与者：回顾并描述2006年6月1日至2008年12月31日期间向VAERS（一个全国性的、自愿的、被动监测系统）报告的免疫接种后不良事件（AEFI）。对一些上市前试验中的AEFI、严重程度异常的AEFI或受到公众关注的AEFI进行了额外分析。使用统计数据挖掘方法，包括比例报告率（PRR）和经验贝叶斯几何平均法，来检测报告中的不均衡性。
报告的AEFI数量、报告率（每10万剂分发疫苗的报告数或每10万人年的报告数）以及与预期背景率的比较。
VAERS收到了12424份接种qHPV后的AEFI报告，每10万剂分发疫苗的报告率为53.9份。共有772份报告（占所有报告的6.2%）描述了严重AEFI，包括32份死亡报告。每10万剂qHPV分发疫苗的报告率分别为：晕厥8.2份；局部部位反应7.5份；头晕6.8份；恶心5.0份；头痛4.1份；过敏反应3.1份；荨麻疹2.6份；静脉血栓栓塞事件、自身免疫性疾病和格林-巴利综合征0.2份；过敏反应和死亡0.1份；横贯性脊髓炎和胰腺炎0.04份；运动神经元病0.009份。数据挖掘方法显示晕厥和静脉血栓栓塞事件的报告不均衡。
与其他疫苗相比，大多数AEFI率不高于背景率，但晕厥和静脉血栓栓塞事件的报告存在不均衡性。这些发现的意义必须结合被动报告系统的局限性（可能存在报告不足）来考量。
