Moro Pedro L, Winiecki Scott, Lewis Paige, Shimabukuro Tom T, Cano Maria
Immunization Safety Office, Centers for Disease Control and Prevention, United States.
Center for Biologics Evaluation and Research, Food and Drug Administration, United States.
Vaccine. 2015 Nov 27;33(48):6684-8. doi: 10.1016/j.vaccine.2015.10.084. Epub 2015 Oct 27.
In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the US for adults aged ≥ 18 years.
To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
We searched VAERS for US reports after ccIIV3 among persons vaccinated from July 1, 2013-March 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category using MedDRA system organ classes (SOC) to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following ccIIV3.
VAERS received 629 reports following ccIIV3 of which 313 were for administration of vaccine to persons <18 years. Among 309 reports with an AE documented, 19 (6.1%) were serious and the most common categories were 152 (49.2%) general disorders and administration site conditions (mostly injection site and systemic reactions) and 73 (23.6%) immune system disorders with two reports of anaphylaxis. Four reports of GBS were submitted. Disproportional reporting was identified for 'drug administered to patient of inappropriate age.'
Review of VAERS reports did not identify any concerning pattern of AEs after ccIIV3. Injection site and systemic reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Reports following ccIIV3 in persons <18 years highlight the need for education of healthcare providers regarding approved ccIIV3 use.
2012年11月，首款细胞培养流感疫苗——三价亚单位灭活流感疫苗（Flucelvax(®)，ccIIV3）在美国获批用于18岁及以上成年人。
评估向美国疫苗不良事件报告系统（VAERS，一个自发报告监测系统）报告的ccIIV3接种后的不良事件（AE）。
我们在VAERS中搜索了2013年7月1日至2015年3月31日期间接种ccIIV3的美国报告。对于分类为严重（死亡、住院、延长住院时间、残疾、危及生命的疾病）以及提示过敏反应和吉兰-巴雷综合征（GBS）的报告，索取了医疗记录。医生审查了可用信息，并使用MedDRA系统器官分类（SOC）为每份报告指定一个主要临床类别。采用经验贝叶斯数据挖掘来识别ccIIV3接种后不成比例的AE报告。
VAERS收到了629份ccIIV3接种后的报告，其中313份是针对18岁以下人群接种疫苗的报告。在309份记录了AE的报告中，19份（6.1%）为严重报告，最常见的类别是152份（49.2%）一般疾病和接种部位状况（主要是注射部位和全身反应）以及73份（23.6%）免疫系统疾病，有两份过敏反应报告。提交了4份GBS报告。发现“给不适当年龄的患者用药”存在不成比例报告。
对VAERS报告的审查未发现ccIIV3接种后有任何令人担忧的AE模式。注射部位和全身反应是最常报告的AE，与上市前临床试验情况相似。18岁以下人群接种ccIIV3后的报告凸显了对医疗保健提供者进行ccIIV3批准使用教育的必要性。
