The "Fluad Case" in Italy: Could it have been dealt differently?
The "Fluad Case" in Italy: Could it have been dealt differently?
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DOI：
10.1080/21645515.2017.1264738
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发表时间：
2017-01-01
影响因子：
4.8
通讯作者：
Bonanni, Paolo
中科院分区：
文献类型：
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作者：
Levi, Miriam;Sinisgalli, Ersilia;Bonanni, Paolo
在2014-2015年流感疫苗接种活动期间，据报道接种Fluad后48小时内有3人死亡，意大利药品管理局（AIFA）基于预防原则宣布撤回两批疫苗。意大利国家卫生研究院和欧洲药品管理局 (EMA) 负责监测和评估人类药物安全性的委员会药物警戒风险评估委员会 (PRAC) 进行的调查得出的结论是，报告的死亡与所接种的疫苗之间不存在因果关系。然而，AIFA 决定的媒体影响导致流感疫苗接种率较前几年有所下降。我们研究的目的是确定可能导致事件管理不完美的可能关键点。对现有监管框架进行了审查，特别关注 EMA 为促进信号管理流程而制定的良好药物警戒实践指南。报告的管理涉及以下步骤：信号检测、其验证和确认、分析和优先级排序、评估、行动建议和信息交换。我们认为，信号检测阶段和验证阶段都至关重要：即使出现单一疑似严重不良反应，也可以撤回疫苗批次。然而，还应考虑诸如生物学合理性、潜在替代原因的存在以及先前的认识等方面。此外，报告的死亡人数与疫苗接种队列中预期的背景死亡率一致。媒体对 AIFA 决定的过度报道导致普通人群对疫苗的信心下降，免疫覆盖率下降。现阶段，改善疫苗安全问题的沟通对于恢复人们对这一强大的一级预防工具的信任气氛至关重要。
During the influenza vaccination campaign 2014-2015, the reporting of 3 deaths within 48 hours of vaccination with Fluad brought the Italian Medicines Agency (AIFA) to pronounce the withdrawal of 2 batches of vaccine, based on the precautionary principle. Investigations by the Italian National Institute of Health, and by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee at the European Medicines Agency (EMA) responsible for monitoring and assessing the safety profiles of human drugs, concluded that there was a lack of causality between the reported deaths and the vaccines administered. However, the media impact of the decision taken by AIFA, resulted in a lower influenza vaccination coverage compared with the previous years. The aim of our study was to identify possible critical points that may have led to a non-perfect management of the event. A review of the regulatory framework in place was performed, with a particular focus on the Guidelines on Good Pharmacovigilance Practices developed by the EMA to facilitate the signal management process. The management of reports involves the following steps: signal detection, its validation and confirmation, analysis and prioritization, assessment, recommendations for action and the exchange of information. In our opinion, both the signal detection phase and the phase of validation have been critical: the withdrawal of vaccine batches is possible even in case of a single suspected serious adverse reaction. However, aspects such as the biological plausibility, the presence of potential alternative causes and previous awareness should also be considered. Furthermore, the number of reported deaths was consistent with the expected background mortality rate in the vaccinated cohort. The disproportionate media coverage given to the AIFA decision resulted in a reduced vaccine confidence in the general population and in a decreased immunization coverage. Improving the communication on vaccine safety issues is crucial at this stage to restore a climate of trust in this powerful tool for primary prevention.