Journal of Infection 83 (2021) 17–26 Contents lists available at ScienceDirect Journal of Infection journal homepage: www.elsevier.com/locate/jinf Review Recent advances in meningococcal B disease prevention: real-world evidence from 4CMenB vaccination Federico Martinón-Torres a,1 , Angelika Banzhoff b,2,∗ , Chiara Azzari c,3 , Philippe De Wals d,4 , Robin Marlow e,5 , Helen Marshall f,6 , Mariagrazia Pizza g,7 , Rino Rappuoli g,7 , Rafik Bekkat-Berkani h,8 a Hospital Clínico Universitario de Santiago de Compostela and University of Santiago, A Choupana, s/n, 15706 Santiago de Compostela, Spain b GSK, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany c University of Florence, Dipartimento di Scienze della Salute, Florence, Italy d Department of Social and Preventive Medicine, Laval University, Division of Biological Risks and Occupational Health, Quebec National Public Health Institute (Direction des risques biologiques et de la santé au travail, Institut national de santé publique du Québec), and Quebec University Hospital Research Centre, Quebec City, Canada e Bristol Medical School, University of Bristol, Bristol, BS8 ∗ 2PS, United Kingdom f VIRTU, Women’s and Children’s Health Network & Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, Australia g GSK, via Fiorentina 1, 53100 Siena, Italy h GSK, Rockville, MD, USA a r t i c l e i n f o Article history: Accepted 25 April 2021 Available online 30 April 2021 Editor: Prof. R. Read Keywords: 4CMenB Effectiveness Impact Neisseria meningitis serogroup B Vaccine Safety s u m m a r y Objectives: 4CMenB is a broadly protective vaccine against invasive meningococcal capsular group B dis- ease (MenB IMD). Licensed worldwide based on immunogenicity and safety data, effectiveness and im- pact data are now available. We comprehensively reviewed all available real-world evidence gathered from use of 4CMenB since licensure. Results: 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. Conclusion: 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; in- fants/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. © 2021 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd on behalf of The British Infection Association. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) ∗ Corresponding author at: GSK, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany. E-mail address: [email protected] (A. Banzhoff). 1 (ORCID 0000-0002-9023-581X) 2 (ORCID 0000-0002-8813-282X) 3 (ORCID 0000-0001-7236-1655) 4 (ORCID 0000-0002-9239-3096) 5 (ORCID 0000-0002-3192-3102) 6 (ORCID 0000-0003-2521-5166) Introduction to 4CMenB Meningitis and septicemia caused by Neisseria meningitidis are uncommon but life-threating diseases that can result in death or permanent sequelae. Of the 6 serogroups that cause the major- ity of invasive meningococcal disease (IMD) in humans (A, B, C, 7 (ORCID MP: 0000-0002-7800-1404; RR: 0000-0002-8827-254X) 8 (ORCID 0000-0003-0683-6055) https://doi.org/10.1016/j.jinf.2021.04.031 0163-4453/© 2021 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd on behalf of The British Infection Association. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
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