2012年6月1日至2015年12月31日美国疫苗不良事件报告系统（VAERS）对19岁及以上成年人中13价肺炎球菌结合疫苗（PCV13）的上市后监测。
Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015.
作者信息
Haber Penina, Arana Jorge, Pilishvili Tamara, Lewis Paige, Moro Pedro L, Cano Maria
机构信息
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 30329, United States.
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 30329, United States.
出版信息
Vaccine. 2016 Dec 7;34(50):6330-6334. doi: 10.1016/j.vaccine.2016.10.052. Epub 2016 Nov 9.
BACKGROUND
The 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged ⩾19years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged ⩾65years.
METHODS
We assessed adverse events (AEs) reports following PCV13 in adults aged ⩾19years reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to December 2015. VAERS is a national spontaneous reporting system for monitoring AEs following vaccination. Our assessment included automated data analysis, clinical review of all serious reports and reports of special interest. We conducted empirical Bayesian data mining to assess for disproportionate reporting.
RESULTS
VAERS received 2976 US PCV13 adult reports; 2103 (71%) of these reports were from PCV13 administered alone. Fourteen percent were in persons aged 19-64years and 86% were in persons aged ⩾65years. Injection site erythema (28%), injection site pain (24%) and fever (22%) were the most frequent AEs among persons aged 19-64years; injection site erythema (30%), erythema (20%) and injection site swelling (18%) were the most frequent among persons aged ⩾65years who were given the vaccine alone. The most frequently reported AEs among non-death serious reports were injection site reactions and general malaise among persons 19-64years old; injection site reactions, general malaise and Guillain-Barré syndrome among those ⩾65years (Table 2). Data mining did not detect disproportional reporting for any unexpected AE.
CONCLUSIONS
The results of this study were consistent with safety data from pre-licensure studies of PCV13. We did not detect any new or unexpected AEs.
背景
2012年6月，13价肺炎球菌结合疫苗（PCV13）首次被推荐用于年龄≥19岁的免疫功能低下成人。2014年8月，免疫实践咨询委员会（ACIP）建议在年龄≥65岁的成人中常规使用PCV13。
方法
我们评估了2012年6月至2015年12月期间向疫苗不良事件报告系统（VAERS）报告的年龄≥19岁成人接种PCV13后的不良事件（AE）报告。VAERS是一个用于监测疫苗接种后AE的全国性自发报告系统。我们的评估包括自动数据分析、对所有严重报告和特殊关注报告的临床审查。我们进行了经验贝叶斯数据挖掘以评估不成比例报告情况。
结果
VAERS收到了2976份美国PCV13成人报告；其中2103份（71%）报告来自单独接种PCV13的情况。14%的报告涉及19 - 64岁的人群，86%的报告涉及年龄≥65岁的人群。在19 - 64岁的人群中，注射部位红斑（28%）、注射部位疼痛（24%）和发热（22%）是最常见的AE；在单独接种疫苗的年龄≥65岁的人群中，注射部位红斑（30%）、红斑（20%）和注射部位肿胀（18%）是最常见的。在非死亡严重报告中，19 - 64岁人群中最常报告的AE是注射部位反应和全身不适；在年龄≥65岁的人群中是注射部位反应、全身不适和吉兰 - 巴雷综合征（表2）。数据挖掘未检测到任何意外AE的不成比例报告。
结论
本研究结果与PCV13上市前研究的安全性数据一致。我们未检测到任何新的或意外的AE。
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