Systematic causality assessment of adverse events following HPV vaccines: Analysis of current data from Apulia region (Italy)
Systematic causality assessment of adverse events following HPV vaccines: Analysis of current data from Apulia region (Italy)
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DOI：
10.1016/j.vaccine.2018.01.018
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发表时间：
2018-02-14
期刊：
影响因子：
5.5
通讯作者：
Prato, Rosa
中科院分区：
文献类型：
--
作者：
Tafuri, Silvio;Fortunato, Francesca;Prato, Rosa
自2013年以来，世界卫生组织（世卫组织）建议应通过因果关系评估的标准化算法评估免疫接种后不良事件（AEFIs），但很少采用世卫组织程序。在意大利，aefi（仅按时间标准分类）在国家药物管理局（AIFA）数据库中注册，但因果关系评估不是强制性的。每年，AIFA都会发布aefi的报告，其中不包含事件与疫苗之间因果关系的信息。从AIFA数据库中，我们选择了2008-2016年Apulia（约400万居民）报告的人乳头瘤病毒（HPV）疫苗接种后的aefi。对于严重的空气污染，我们采用了世卫组织的因果关系评估标准；对于住院病例，我们重复评估，从健康文件中获取更多信息。2008-2016年，登记了100例HPV急性感染（报告率：每10万剂17.8例），其中19例严重（报告率：每10万剂3.4例），12例导致住院。经因果关系评估，9例急性呼吸道感染事件的分类为“与免疫有一致的因果关系”，3例不确定，5例“与免疫有不一致的因果关系”，2例不可分类。住院患者中，5例aefi一致，5例不一致，1例不可分，1例不确定；加上来自健康文件的信息，结果是相似的，除了不确定和不可分类的aefi变成“不一致”。只有一半的严重急性呼吸道感染可能与疫苗接种有关，这表明AIFA报告提供了HPV疫苗安全性的不完整情况，读者有可能在不考虑因果关系评估结果的情况下混淆“事后”和“适当的临时”方法。鉴于在AEFI监测中系统地使用世卫组织因果关系评估算法，公共卫生部门的工作必须侧重于提高所提供信息的质量，以减少结论在观察者之间的差异；必须保证报告的例行后续工作，也是为了收集更多的资料。(C) 2018 Elsevier Ltd.版权所有。
Since 2013, World Health Organization (WHO) recommended that adverse events following immunization (AEFIs) should be evaluated by a standardized algorithm for causality assessment, however the use of WHO procedure is rarely adopted. In Italy, AEFIs (classified only by temporal criteria) are registered in the National Drug Authority (AIFA) database, but causality assessment is not mandatory. Every year AIFA publishes the AEFIs report, that doesn't contain information about causal correlation between events and vaccines. From AIFA database, we selected AEFIs following human papillomavirus vaccination (HPV) reported in Apulia (about 4,000,000 inhabitants) during 2008-2016. For serious AEFIs, we applied WHO causality assessment criteria; for cases hospitalized, we repeated the assessment getting additional information from health documentation. In 2008-2016, 100 HPV AEFIs (reporting rate: 17.8 per 100,000 doses) were registered of which 19 were serious (rate: 3.4 per 100,000 doses) and 12 led to hospitalization. After causality assessment, for 9 AEFIs the classification was "consistent causal association to immunization", for 3 indeterminate, for 5 "inconsistent causal association to immunization" and for 2 not-classifiable. Among hospitalized patients, 5 AEFIs were consistent, 5 inconsistent, 1 not-classifiable and 1 indeterminate; adding information from health documentation, the results were similar except for indeterminate and not classifiable AEFIs that turned into "not consistent". Only half of severe AEFIs could be associated with vaccination and this suggests that AIFA report provides a incomplete picture of HPV vaccine safety, with a risk for readers to confound "post hoc" and "propter hoc" approach without considering the causality assessment results. In the view of the systematic use of WHO causality assessment algorithm in the AEFI surveillance, the efforts of Public Health must be focused on the improvement of the quality of the information provided to reduce conclusions inter-observer variability; the routine follow-up of reports, also to collect additional information, must be guaranteed. (C) 2018 Elsevier Ltd. All rights reserved.