Post-licensure surveillance of quadrivalent live attenuated influenza vaccine United States, Vaccine Adverse Event Reporting System (VAERS), July 2013-June 2014
Post-licensure surveillance of quadrivalent live attenuated influenza vaccine United States, Vaccine Adverse Event Reporting System (VAERS), July 2013-June 2014
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DOI：
10.1016/j.vaccine.2015.01.080
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发表时间：
2015-04-15
期刊：
影响因子：
5.5
通讯作者：
Shimabukuro, Tom T.
中科院分区：
文献类型：
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作者：
Haber, Penina;Moro, Pedro L.;Shimabukuro, Tom T.
背景：四价流感减毒活疫苗（LAIV 4）于2012年获批用于2-49岁健康人群。从2013-2014年流感季节开始，LAIV 4取代了三价流感减毒活疫苗（LAIV 3）。将2013-2014年的LAIV 4报告与前三个流感季节的LAIV 3报告进行比较。审查病历中的非制造商严重报告（即，死亡、住院、延长住院、危及生命的疾病、永久性残疾）以及所关注的选定病症的报告。结果：2013-2014年，全国共发放LAIV 4疫苗1270万剂，VAERS共收到779例2-49岁患者报告，95%为非严重病例。当LAIV 4单独给药时，2-17岁儿童最常报告的是使用过期药物（42%）、发热（13%）和咳嗽（8%），而头痛（18%）、使用过期药物（15%）和妊娠期间暴露（12%）在18-49岁成人中最常见。我们确定了一例儿童死于小脑血管肿瘤并发症的死亡报告。在非死亡严重报告中，神经系统疾病在儿童和成人中常见。在儿童中，癫痫发作（3）和格林巴利。综合征（2）是最常见的严重神经系统结局。我们确定了3例儿童LAIV 4后哮喘/喘息的严重报告。数据挖掘检测不成比例的报告疫苗管理错误和流感疾病的childhen.Conclusions：我们的分析LAIV 4的VAERS报告没有发现任何有关的模式。流感疾病报告的数据挖掘结果与2013-2014年在儿童中观察到的LAIV 4疫苗对甲型流感疾病的低有效性一致。对不推荐接种疫苗的人接种LAIV 4的报告（例如，孕妇）表示需要有关适应症的教育、培训和筛查。爱思唯尔有限公司出版
Background: Quadrivalent live attenuated influenza vaccine (LAIV4) was approved in 2012 for healthy persons aged 2-49 years. Beginning with the 2013-2014 influenza season, LAIV4 replaced trivalent live attenuated influenza vaccine (LAIV3).Methods: We analyzed LAIV4 reports to VAERS, a national spontaneous reporting system. LAIV4 reports in 2013-2014 were compared to LAIV3 reports from the previous three influenza seasons. Medical records were reviewed for non-manufacturer serious reports (i.e., death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability) and reports of selected conditions of interest. We conducted Empirical Bayesian data mining to identify disproportional reporting for LAIV4.Results: In 2013-2014, 12.7 million doses of LAIV4 were distributed and VAERS received 779 reports in individuals aged 2-49 years; 95% were non-serious. Expired drug administered (42%), fever (13%) and cough (8%) were most commonly reported in children aged 2-17 years when LAIV4 was administered alone, while headache (18%), expired drug administered (15%) and exposure during pregnancy (12%) were most common in adults aged 18-49 years. We identified one death report in a child who died from complications of cerebellar vascular tumors. Among non-death serious reports, neurologic conditions were common in children and adults. In children, seizures (3) and Guillain-Barre. syndrome (2) were the most common serious neurologic outcomes. We identified three serious reports of asthma/wheezing following LAIV4 in children. Data mining detected disproportional reporting for vaccine administration errors and for influenza illness in children.Conclusions: Our analysis of VAERS reports for LAIV4 did not identify any concerning patterns. The data mining finding for reports of influenza illness is consistent with low LAIV4 vaccine effectiveness observed for influenza A disease in children in 2013-2014. Reports of LAIV4 administration to persons in whom the vaccine is not recommended (e.g., pregnant women) indicate the need for education, training and screening regarding indications. Published by Elsevier Ltd.