Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).
Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).
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DOI：
10.1016/j.vaccine.2015.07.035
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发表时间：
2015-08-26
期刊：
影响因子：
5.5
通讯作者：
DeStefano F
中科院分区：
文献类型：
--
作者：
Shimabukuro TT;Nguyen M;Martin D;DeStefano F
美国疾病控制和预防中心（CDC）和美国食品药品监督管理局（FDA）使用疫苗不良事件报告系统（VAERS）进行许可后疫苗安全性监测，这是一种自发（或被动）报告系统。这意味着在疫苗获得批准后，CDC和FDA通过收集和分析接种疫苗后发生的不良事件的自发报告，继续监测疫苗在市场上分发的安全性。使用各种方法和统计技术来分析VAERS数据，CDC和FDA使用这些数据来指导进一步的安全性评估，并为疫苗推荐和监管行动提供信息。由于被动监测的固有局限性，必须谨慎解释VAERS数据。VAERS主要是一个安全信号检测和假设生成系统。一般来说，VAERS数据不能用于确定疫苗是否引起不良事件。单独或断章取义地解释VAERS数据可能会导致关于因果关系以及疫苗接种后发生不良事件风险的错误结论。CDC向公众提供VAERS数据，并随时在线访问。我们描述了基本的疫苗安全性概念，为提供疫苗接种并可能希望报告或更好地了解疫苗不良事件的医疗保健专业人员提供了VAERS的概述，并解释了CDC和FDA如何分析VAERS数据。我们还描述了优势和局限性，并解决有关VAERS的常见误解。本综述中的信息将有助于医疗保健专业人员为患者、父母和其他人提供疫苗安全性和疫苗接种的获益-风险平衡方面的咨询。
The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination.