Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system
Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system
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DOI：
10.1016/j.puhe.2015.11.010
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发表时间：
2016-06-01
期刊：
影响因子：
5.2
通讯作者：
Lluch-Rodrigo, J. A.
中科院分区：
文献类型：
--
作者：
Alguacil-Ramos, A. M.;Muelas-Tirado, J.;Lluch-Rodrigo, J. A.
目标：监测疫苗安全性是疫苗接种规划的一项基本要求。计算机化免疫登记，如巴伦西亚社区（西班牙）的疫苗接种信息系统（SIV），提供了根据个人信息估计不良事件发生率的机会。本研究的目的是分析2005年至2011年通过SIV报告的免疫接种后不良事件，按年龄、性别、疫苗类型和剂量以及不良事件进行分类，并突出这种报告类型的优势。研究设计：利用人口健康数据库对巴伦西亚社区接种疫苗的受试者进行回顾性队列研究。方法：对巴伦西亚社区疫苗接种情况和经SIV感染的AEFI报告进行分析。结果：2005 - 2011年接种了1300多万剂疫苗，不良事件报告率为12.4/10万剂，2009年报告率最高（27.4 /10万剂），不同年龄和性别存在差异。DTaP疫苗在儿童中报告最多（96.6/10万），而甲型H1N1流感pdm09疫苗在成人中报告最多（87.7/10万）。在5-6岁的儿童中，实时检测到DTaP的不良事件报告增加，这促使将该疫苗换成低剂量的Tdap，随后给药部位事件减少。结论：SIV在被动监测中具有优势。按个体特征计算的报告率是准确的，它还允许实时检测特定疫苗报告率的变化。研究表明，儿童常规疫苗接种计划和成人疫苗接种计划中的疫苗是安全的。(C) 2015年，皇家公共卫生学会。Elsevier Ltd.出版。版权所有。
Objectives: The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting.Study design: A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out.Methods: Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out.Results: More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1) pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events.Conclusions: SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe. (C) 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.