Muhammad Riyadh, Haber Penina, Broder Karen, Leroy Zanie, Ball Robert, Braun M Miles, Davis Robert L, McMahon Ann W
Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology Rockville, MD, USA.
Pediatr Infect Dis J. 2011 Jan;30(1):e1-8. doi: 10.1097/INF.0b013e3181ff9795.
The Advisory Committee on Immunization Practices' recommendations for influenza vaccination of children have expanded from the long-standing recommendation to vaccinate high-risk children aged ≥6 months, to vaccinating all 6- to 23-month-olds (2004), 2- to 4-year-olds (2006), and 5- to 18-year-olds (2008).
To identify new or unexpected adverse events (AEs) after trivalent inactivated vaccine (TIV) in children.
We analyzed reports after TIV to the Vaccine Adverse Event Reporting System from 1990-2006 in children aged 2 to 17 years, and from the 2008-2009 influenza season in children aged 5 to 17 years. Empiric Bayesian data mining techniques were used to identify new or unexpected AEs during 1990-2006.
During 1990-2006, the Vaccine Adverse Event Reporting System received 2054 reports of children aged 2 to 17 years with a peak in the 2003-2004 influenza season. In 2008-2009, 506 reports describing 5 to 17 year olds were received. The serious reports of tests performed after TIV were approximately 10% of all reports from 2001-2006, and 6% of the reports in the 2008-2009 season. Data mining showed an increased proportion of medication errors and Guillain Barré Syndrome (GBS). The findings of GBS could not be interpreted as causally related to vaccination. Among 201 reports of medication error, 94% had no AE reported other than the medication error itself.
In this analysis, we found no unexpected AEs. Our review of medication error and GBS reports suggests that ongoing monitoring in these areas is appropriate.
免疫实践咨询委员会对儿童流感疫苗接种的建议已从长期以来为≥6个月的高危儿童接种疫苗，扩展到为所有6至23个月大的儿童（2004年）、2至4岁的儿童（2006年）以及5至18岁的儿童（2008年）接种疫苗。
确定儿童接种三价灭活疫苗（TIV）后出现的新的或意外的不良事件（AE）。
我们分析了1990 - 2006年2至17岁儿童以及2008 - 2009流感季节5至17岁儿童向疫苗不良事件报告系统报告的TIV接种后情况。采用经验贝叶斯数据挖掘技术来确定1990 - 2006年期间新的或意外的不良事件。
1990 - 2006年期间，疫苗不良事件报告系统收到了2054份2至17岁儿童的报告，在2003 - 2004流感季节达到峰值。2008 - 2009年，收到了506份描述5至17岁儿童的报告。TIV接种后进行的检测的严重报告约占2001 - 2006年所有报告的10%，以及2008 - 2009季节报告的6%。数据挖掘显示用药错误和吉兰 - 巴雷综合征（GBS）的比例有所增加。GBS的发现不能解释为与疫苗接种有因果关系。在201份用药错误报告中，94%除了用药错误本身外没有报告其他不良事件。
在本分析中，我们未发现意外的不良事件。我们对用药错误和GBS报告的审查表明，在这些领域进行持续监测是合适的。
