Hospital Clínico Universitario de Santiago de Compostela and University of Santiago, A Choupana, s/n, 15706 Santiago de Compostela, Spain.
GSK, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany.
J Infect. 2021 Jul;83(1):17-26. doi: 10.1016/j.jinf.2021.04.031. Epub 2021 Apr 30.
4CMenB is a broadly protective vaccine against invasive meningococcal capsular group B disease (MenB IMD). Licensed worldwide based on immunogenicity and safety data, effectiveness and impact data are now available. We comprehensively reviewed all available real-world evidence gathered from use of 4CMenB since licensure.
Data from 7 countries provide evidence of effectiveness and impact across different healthcare settings and age-groups, including national/regional immunization programs, observational studies and outbreak control. At least 2 4CMenB doses reduced MenB IMD by 50%-100% in 2-month to 20-year-olds depending on length of follow-up. Estimates of vaccine effectiveness in fully vaccinated cohorts ranged from 59%-100%. The safety profile of 4CMenB administered in real-world settings was consistent with pre-licensure clinical trial data.
MenB IMD is an uncommon but life-threatening disease with unpredictable epidemiology. The substantial body of data demonstrating 4CMenB effectiveness and impact supports its use in IMD prevention. The results reinforce the importance of direct protection of the highest risk groups; infants/young children and adolescents. Direct protection via routine infant immunization with catch-up in young children and routine adolescent vaccination could be the preferred option for MenB disease control. A Video Abstract linked to this article is available on Figshare: https://doi.org/10.6084/m9.figshare.14546790.
4CMenB 是一种广泛保护性的针对侵袭性脑膜炎奈瑟菌 B 群疾病（MenB IMD）的疫苗。该疫苗基于免疫原性和安全性数据在全球获得许可，目前已有有效性和影响力数据。我们全面审查了自许可以来使用 4CMenB 收集的所有可用真实世界证据。
来自 7 个国家的数据提供了在不同医疗保健环境和年龄组中使用 4CMenB 的有效性和影响力的证据，包括国家/地区免疫计划、观察性研究和暴发控制。根据随访时间的不同，至少 2 剂 4CMenB 可将 2 个月至 20 岁儿童和青少年的 MenB IMD 降低 50%-100%。完全接种疫苗的队列中疫苗有效性的估计值在 59%-100%之间。在真实环境中使用 4CMenB 的安全性概况与上市前临床试验数据一致。
MenB IMD 是一种罕见但危及生命的疾病，其流行病学不可预测。大量数据表明 4CMenB 的有效性和影响力，支持其用于预防 IMD。这些结果强调了直接保护最高风险群体（婴儿/幼儿和青少年）的重要性。通过常规婴儿免疫接种、幼儿补种和常规青少年疫苗接种进行直接保护可能是控制 MenB 疾病的首选方案。本文的视频摘要可在 Figshare 上查看：https://doi.org/10.6084/m9.figshare.14546790。
