Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
Vaccine. 2019 Mar 7;37(11):1516-1520. doi: 10.1016/j.vaccine.2019.01.052. Epub 2019 Feb 7.
Trivalent adjuvanted influenza vaccine (aIIV3; Fluad®) was approved in the United States (U.S.) in 2015 for adults aged ≥65 years and has been in use since the 2016-17 influenza season.
We analyzed U.S. reports for aIIV3 submitted from July 1, 2016 through June 30, 2018 to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. Medical records were reviewed for serious reports. Among individuals ≥65 years of age, the relative frequency of the most commonly reported adverse events (AEs) after aIIV3 were compared with non-adjuvanted inactivated influenza vaccines given to adults aged ≥65 years, high-dose trivalent influenza vaccine (IIV3-HD) and trivalent or quadrivalent vaccines (IIV3/IIV4). Data mining analyses were undertaken to identify whether AEs for aIIV3 occurred disproportionately more than expected compared to all influenza vaccines.
VAERS received 630 reports after aIIV3, of which 521 (83%) were in adults aged ≥65 years; 79 (13%) in persons <65 years and in 30 (5%) reports age was missing; 19 (3%) reports were serious, including two deaths (0.4%) related to myocardial infarction and Sjogren's syndrome. The most common AEs reported in adults aged ≥65 years were injection site pain (21%) and erythema (18%), with similar proportions reported for IIV3-HD (17% and 19%, respectively) and for IIV3/IIV4 (15%, each). Except for reports related to vaccination of inappropriate age (n = 79) and syringe malfunction (n = 6), data mining did not identify other disproportionately reported AEs.
Although our review of aIIV3 in VAERS did not identify any unexpected health conditions of concern, we observed more than twice the expected number of reports with administration of the vaccine to persons outside of the age range for which the vaccine is approved in the U.S. Health care providers should be educated on the age groups for whom aIIV3 is recommended.
三价佐剂流感疫苗（aIIV3；Fluad®）于 2015 年在美国获得批准，用于年龄≥65 岁的成年人，并自 2016-17 流感季节开始使用。
我们分析了 2016 年 7 月 1 日至 2018 年 6 月 30 日期间向疫苗不良事件报告系统（VAERS）提交的 aIIV3 美国报告，VAERS 是一个全国性的自发报告系统。对严重报告进行了病历审查。在年龄≥65 岁的人群中，与接种给年龄≥65 岁成年人的非佐剂灭活流感疫苗、高剂量三价流感疫苗（IIV3-HD）和三价或四价疫苗（IIV3/IIV4）相比，比较 aIIV3 后最常报告的不良事件（AE）的相对频率。进行了数据挖掘分析，以确定 aIIV3 的 AE 是否与所有流感疫苗相比不成比例地更常见。
VAERS 收到了 630 份 aIIV3 报告，其中 521 份（83%）来自年龄≥65 岁的成年人；79 份（13%）来自<65 岁的人群，30 份（5%）报告年龄缺失；19 份（3%）报告为严重报告，包括与心肌梗死和干燥综合征相关的 2 例死亡（0.4%）。年龄≥65 岁的成年人报告的最常见 AE 为注射部位疼痛（21%）和红斑（18%），与 IIV3-HD（分别为 17%和 19%）和 IIV3/IIV4（各 15%）报告的比例相似。除了与不适当年龄接种（n=79）和注射器故障（n=6）相关的报告外，数据挖掘未发现其他不成比例报告的 AE。
尽管我们对 VAERS 中的 aIIV3 进行了审查，但并未发现任何令人担忧的意外健康状况，但我们观察到，在疫苗批准的美国年龄范围之外接种疫苗的报告数量是预期的两倍多。应向医疗保健提供者提供有关推荐 aIIV3 的年龄组的教育。
