Recent advances in meningococcal B disease prevention: real-world evidence from 4CMenB vaccination - 19/06/21
, 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, 8Editor: Prof. R. Read
Highlights |
• | Evidence of 4CMenB effectiveness, impact, and safety in routine use is now available |
• | Data are presented from Quebec, South Australia, UK, Italy and Portugal |
• | MenB invasive disease cases decreased by 50-100% in vaccine-eligible populations |
• | Statistically significant vaccine effectiveness (79-100% ≥2 doses) was demonstrated |
• | 4CMenB demonstrated an acceptable safety profile in routine use |
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.
A Video Abstract linked to this article is available on Figshare: m9.figshare.14546790.
Le texte complet de cet article est disponible en PDF.Keywords : 4CMenB, Effectiveness, Impact, Neisseria meningitis serogroup B, Vaccine, Safety
Plan
Vol 83 - N° 1
P. 17-26 - juillet 2021 Retour au numéro
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