Haber Penina, Moro Pedro L, McNeil Michael M, Lewis Paige, Woo Emily Jane, Hughes Hayley, Shimabukuro Tom T
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.
Vaccine. 2014 Nov 12;32(48):6499-504. doi: 10.1016/j.vaccine.2014.09.018. Epub 2014 Sep 22.
Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults.
We searched Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged ≥ 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season.
During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n=207, 17%), headache (n=192, 16%), and fever (n=133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n=40, 39%), cardiovascular (n=14, 14%), and other non-infectious conditions (n=20, 19%). We noted a higher proportion of Guillain-Barré syndrome (GBS) and cardiovascular reports in the Department of Defense (DoD) population compared to the civilian population. Data mining detected disproportional reporting of ataxia (n=15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS.
Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in the DoD population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications.
三价减毒活流感疫苗（LAIV3）于2003年获得许可并被推荐用于2至49岁的儿童和成人。上市后安全性数据有限，尤其是在成人中。
我们检索了疫苗不良事件报告系统（VAERS），以获取2005年7月1日至2013年6月30日（八个流感季节）≥18岁成人中LAIV3接种后的美国报告。我们进行了描述性分析，并对严重报告（即死亡、危及生命的疾病、住院、长期住院或永久性残疾）以及选定的感兴趣疾病的报告进行了临床审查。我们使用经验贝叶斯数据挖掘来识别报告频率高于预期的不良事件（AE）。我们按流感季节计算了向VAERS报告的AE粗率。
在研究期间，VAERS收到了1207份18至49岁成人接种LAIV3的报告；107份（8.9%）为严重报告，包括4份死亡报告。最常报告的事件是接种过期疫苗（n = 207，17%）、头痛（n = 192，16%）和发热（n = 133，11%）。非致命严重报告最常见的诊断类别是神经系统疾病（n = 40，39%）、心血管疾病（n = 14，14%）和其他非感染性疾病（n = 20，19%）。我们注意到，与平民人群相比，国防部人群中格林-巴利综合征（GBS）和心血管疾病报告的比例更高。数据挖掘发现共济失调报告比例失调（n = 15）；临床审查显示，共济失调是包括GBS在内的多种临床病症的一个组成部分。
对VAERS报告的审查令人放心，LAIV3唯一意外的安全问题是国防部人群中GBS报告数量高于预期，目前正在对此进行调查。接种过期LAIV3的报告代表给药错误，表明需要对批准的适应症进行教育、培训和筛查。
