Federico Martinón-Torres1, Angelika Banzhoff2, Chiara Azzari3, Philippe De Wals4, Robin Marlow5, Helen Marshall6, Mariagrazia Pizza7, Rino Rappuoli7, Rafik Bekkat-Berkani8. 1. Hospital Clínico Universitario de Santiago de Compostela and University of Santiago, A Choupana, s/n, 15706 Santiago de Compostela, Spain. 2. GSK, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany. Electronic address: angelika.x.banzhoff@gsk.com. 3. University of Florence, Dipartimento di Scienze della Salute, Florence, Italy. 4. 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. 5. Bristol Medical School, University of Bristol, Bristol, BS8* 2PS, United Kingdom. 6. VIRTU, Women's and Children's Health Network & Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, Australia. 7. GSK, via Fiorentina 1, 53100 Siena, Italy. 8. GSK, Rockville, MD, USA.
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: https://doi.org/10.6084/m9.figshare.14546790.
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: https://doi.org/10.6084/m9.figshare.14546790.
Authors: Pasquale Stefanizzi; Francesco Paolo Bianchi; Andrea Martinelli; Antonio Di Lorenzo; Paola De Petro; Giusi Graziano; Sabrina Lattanzio; Giusy Diella; Paolo Stella; Domenica Ancona; Silvio Tafuri Journal: Hum Vaccin Immunother Date: 2022-02-24 Impact factor: 3.452