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四价脑膜炎球菌结合疫苗的当前安全性问题。

Current safety issues with quadrivalent meningococcal conjugate vaccines.

机构信息

a Immunization Safety Office, Division of Healthcare Quality Promotion , National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , GA , USA.

b Department of Epidemiology , Rollins School of Public Health, Emory University , Atlanta , GA , USA.

出版信息

Hum Vaccin Immunother. 2018 May 4;14(5):1175-1178. doi: 10.1080/21645515.2017.1366393. Epub 2017 Nov 8.

Abstract

Invasive meningococcal disease, although rare, can present as sudden, life-threatening disease with high risk of mortality or severe long-term sequelae. The main prevention strategy for invasive meningococcal disease in the United States is the routine vaccination of adolescents and other persons at increased risk of meningococcal disease with quadrivalent meningococcal conjugate vaccines. Two such vaccines are currently licensed and available in the United States, Menactra® (Sanofi Pasteur) and Menveo® (GlaxoSmithKline), and usage in the adolescent population has steadily increased since their introduction. Although early reports raised concerns about a possible association of Menactra with Guillain-Barré syndrome, a comprehensive safety review determined that if such risk existed it was no more than 0.66 cases per 1 million vaccinations. More recently, a study found an elevated risk of Bell's palsy when Menveo was administered concomitantly with other vaccines but no association was found when the vaccine was administered alone. In this commentary, we describe the current state of knowledge with respect to the safety of quadrivalent meningococcal conjugate vaccines, and we identify potential areas for safety research for these vaccines.

摘要

侵袭性脑膜炎球菌病虽然罕见,但可表现为突然发生的危及生命的疾病,病死率或严重长期后遗症风险高。侵袭性脑膜炎球菌病在美国的主要预防策略是用四价脑膜炎球菌结合疫苗对青少年和其他脑膜炎球菌病高危人群进行常规疫苗接种。目前有两种此类疫苗在美国获得许可和使用,分别是 Menactra(赛诺菲巴斯德)和 Menveo(葛兰素史克),自推出以来,青少年人群的使用率稳步上升。尽管早期报告对 Menactra 与格林-巴利综合征可能存在关联表示担忧,但一项全面的安全性审查确定,如果存在这种风险,每接种 100 万剂疫苗的病例数不超过 0.66 例。最近,一项研究发现,当同时使用 Menveo 与其他疫苗时,贝尔氏面瘫的风险升高,但当单独使用疫苗时,并未发现关联。在本述评中,我们描述了四价脑膜炎球菌结合疫苗安全性的现有知识状况,并确定了这些疫苗的潜在安全性研究领域。

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