Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring
Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring
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DOI：
10.1016/j.vaccine.2009.01.125
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发表时间：
2009-03-26
期刊：
影响因子：
5.5
通讯作者：
Haber, Penina
中科院分区：
文献类型：
--
作者：
Vellozzi, Claudia;Burwen, Dale R.;Haber, Penina
在准备大流行疫苗安全监测时，我们评估了1990年至2005年成人接种三价灭活流感疫苗后向疫苗不良事件报告系统报告的不良事件。我们计算了非严重、严重和神经系统不良事件的报告率。我们回顾了复发事件和死亡的报告，以及通过先进的信号检测确定的报告。报道最多的事件是局部反应和全身症状。格林-巴利综合征是报道最多的严重事件(每百万份疫苗接种报告0.70份)。随着时间的推移，不良事件报告率一直相当稳定。在我们审查了15年的执照后监测数据后，没有出现新的安全问题。如果大流行疫苗迅速分发，且许可前数据有限，这些发现将提供有用的信息。爱思唯尔有限公司出版。
In preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barre syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited. Published by Elsevier Ltd.