Tong Jiayi, Huang Jing, Du Jingcheng, Cai Yi, Tao Cui, Chen Yong
Perelman School of Medicine, The University of Pennsylvania, Philadelphia, PA, USA.
School of Biomedical Informatics, The University of Texas Health Science Center at Houston, Houston, TX, USA.
AMIA Annu Symp Proc. 2018 Dec 5;2018:1544-1551. eCollection 2018.
In 2012, a new influenza vaccine - FLU4 was first licensed in the US. FLU4 is a quadrivalent flu vaccine, which can protect against four flu viruses. Compared to FLU and FLU3, FLU4 gives broader protection against the flu viruses. To our knowledge, few studies have focused on the FLU4 vaccine and its adverse events. Since safety signal detection is important in vaccination, it is necessary to launch such studies on FLU4. In this paper, we used the Vaccine Adverse Event Reporting System (VAERS), which is a national post-marketing vaccine safety surveillance program to identify rare adverse events with year-varying reporting rates for FLU4. The differences in the reporting rates over years are potential signals of vaccine safety issues caused by updates of FLU4 ingredients. We used a likelihood ratio test to simultaneously test the sparsity of events and the differences of event rates over years. We identified 4 adverse events that are rare and have significantly different reporting rates over years.
2012年，一种新型流感疫苗——FLU4首次在美国获得许可。FLU4是一种四价流感疫苗，可预防四种流感病毒。与FLU和FLU3相比，FLU4对流感病毒的防护范围更广。据我们所知，很少有研究关注FLU4疫苗及其不良事件。由于安全信号检测在疫苗接种中很重要，因此有必要开展关于FLU4的此类研究。在本文中，我们使用了疫苗不良事件报告系统（VAERS），这是一项全国性的上市后疫苗安全监测计划，以识别FLU4在不同年份报告率变化的罕见不良事件。多年来报告率的差异是由FLU4成分更新引起的疫苗安全问题的潜在信号。我们使用似然比检验来同时检验事件的稀疏性和多年来事件发生率的差异。我们确定了4种罕见的不良事件，这些事件在多年来的报告率有显著差异。
