2011 年 10 月至 2018 年 7 月，美国疫苗不良事件报告系统（VAERS）中口服活腺病毒 4 型和 7 型疫苗的不良事件。
Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011-July 2018.
机构信息
Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, GA 30329, USA.
Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, GA 30329, USA.
出版信息
Vaccine. 2019 Oct 16;37(44):6760-6767. doi: 10.1016/j.vaccine.2019.08.087. Epub 2019 Sep 20.
BACKGROUND
In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS).
METHODS
We searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination.
RESULTS
During the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19 years (range 17-32). The most frequently reported serious AEs were Guillain Barré syndrome (GBS) (n = 12) and anaphylaxis (n = 8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%).
CONCLUSIONS
The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile.
背景
2011 年 3 月，美国食品和药物管理局批准腺病毒 4 型和 7 型疫苗，活，口服（Barr 实验室公司）（腺病毒疫苗）用于 17 至 50 岁的军事人员。该疫苗于 2011 年 10 月首次在美军新兵中普遍使用。我们调查了腺病毒疫苗接种后向疫苗不良事件报告系统（VAERS）提交的不良事件（AE）报告。
方法
我们在 VAERS 数据库中搜索了 2011 年 10 月至 2018 年 7 月期间接受腺病毒疫苗接种的美国报告，包括军事观察研究的参与者。我们审查了所有严重报告和随附的医疗记录。我们比较了代理新兵人群中严重报告的比例，并审查了腺病毒疫苗接种后疑似过敏反应的所有报告。
结果
在分析期间，VAERS 收到了 100 份腺病毒疫苗接种后报告；39 份（39%）被归类为严重，其中 17 份（44%）来自观察性研究。报告了一例死亡。报告者中男性占 72%。疫苗接种者的中位年龄为 19 岁（范围 17-32 岁）。最常报告的严重 AE 是格林-巴利综合征（GBS）（n=12）和过敏反应（n=8）；其中，2 例 GBS 和所有过敏反应报告均来自观察性研究。报告记录了同时接种多种其他疫苗（95%）和青霉素 G（IM Pen G）或其他抗生素（50%）。
结论
严重 AE 的报告率高于在比较军事新兵人群中接种的其他疫苗（39%比 18%）；然而，我们没有发现腺病毒疫苗 AE 有任何意外或令人担忧的模式。在这种军事人群中，疫苗和 IM Pen G 的联合使用经常被报告。这些暴露可能导致观察到的腺病毒疫苗的 GBS 和过敏反应结果。在没有这些联合用药的人群中进行未来的腺病毒疫苗安全性研究将有助于阐明疫苗的安全性概况。
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