Recent advances in meningococcal B disease prevention: real-world evidence from 4CMenB vaccination

Abstract

Objectives: 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. 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; 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.

Public Health Impact and Cost-Effectiveness Analysis of Routine Infant 4CMenB Vaccination in Germany to Prevent Serogroup B Invasive Meningococcal Disease

“…The four-component MenB vaccine (4CMenB), licensed in the European Union in 2013, is the only serogroup B vaccine for infants. In Europe, 4CMenB infant vaccination is already included as UMV in the United Kingdom (UK), Ireland, Portugal, Czech Republic, Lithuania, Malta, Italy (including San Marino), Andorra [ 9 ] as well as Austria [ 10 ] and recently France [ 11 ]. After the first 3 years of 4CMenB UMV introduction in the UK in 2015, and based on the high vaccination uptake achieved (i.e.…”

Looking beyond meningococcal B with the 4CMenB vaccine: the Neisseria effect

“…The vaccine was licensed based on clinical trials that gathered safety and immunogenicity data using hSBA assays. Evidence of effectiveness was expected to be collected after licensure 47 .…”

“…To overcome the limitations of the previously described methods, real-world effectiveness and impact data are important. However, these data can only be collected after broad implementation of a vaccine 43 , 47 .…”

Safety profile of MenB-FHBp vaccine among adolescents: data from surveillance of Adverse Events Following Immunization in Puglia (Italy), 2018–2020

“…The first multicomponent MenB vaccine (4CMenB, Bexsero, GSK) was licensed in 2013 in Europe and was based on a new approach to vaccinesʻ preparation, named “reversed vaccinology.” 5 , 6 …”

“…4CMenB and MenB-FHBp were licensed on the basis of safety and immunogenicity using serum bactericidal antibody assays in clinical trials, with the expectation that evidence of effectiveness would be gathered after licensure; safety data in prelicensure trials were deemed acceptable for both vaccines. 6 However, at the time of writing, MenB-FHBp has not been included in national immunization programs in any country and few postmarketing data are available about the safety of this vaccine in the real world.…”