Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for Children
Background: <i>Neisseria meningitidis</i> B is one of the main causative pathogens of meningitis and other forms of severe meningococcal disease. In the past decade, meningococcal B vaccines have been developed to address this infection and its sequelae. Objective: This article aims to p...
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2025-07-01
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| author | Maribel Gonzalez Tome Rosa Gonzalez-Quevedo Maria Escudeiro dos Santos Hans Juergen Dornbusch Sabine Straus Emer Cooke |
| author_facet | Maribel Gonzalez Tome Rosa Gonzalez-Quevedo Maria Escudeiro dos Santos Hans Juergen Dornbusch Sabine Straus Emer Cooke |
| author_sort | Maribel Gonzalez Tome |
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| description | Background: <i>Neisseria meningitidis</i> B is one of the main causative pathogens of meningitis and other forms of severe meningococcal disease. In the past decade, meningococcal B vaccines have been developed to address this infection and its sequelae. Objective: This article aims to present an example of how the EU regulatory framework allowed the early authorisation of two life-saving vaccines initially based on immunogenicity surrogates of clinical evidence. This was subsequently followed by post-marketing surveillance providing real-world evidence to support their safety profile and impact on the paediatric population in the EU. Methods: We review the evidence supporting the initial regulatory approval of the vaccines, the confirmatory data demonstrating vaccine effectiveness post-authorisation, and the real-world impact of these vaccines on the paediatric population. Results: Two vaccines were approved in the EU for active immunisation to prevent IMD caused by MenB (4CMenB in 2013 and MenB-fHBP in 2017). Both marketing authorisations were based on immunogenicity data (efficacy studies were not feasible due to the rarity of the disease) and safety data generated from pre-authorisation studies. Additional pharmacovigilance activities to further investigate the safety profile and effectiveness studies were requested to be conducted after approval. Both the effectiveness and safety profile of the vaccines were confirmed by these data. Conclusions: This paper illustrates that the EU medicines regulatory framework and safety monitoring system are robust. By supplementing the initial evidence with post-authorisation studies, further effectiveness and safety data enabled regulators to confirm the positive benefit–risk of the vaccines without delaying their access to the people who need them. |
| format | Article |
| id | doaj-art-5e6d52d282d642639fec0ae4f9b0b33a |
| institution | Kabale University |
| issn | 2076-393X |
| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj-art-5e6d52d282d642639fec0ae4f9b0b33a2025-08-20T03:32:16ZengMDPI AGVaccines2076-393X2025-07-0113777010.3390/vaccines13070770Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for ChildrenMaribel Gonzalez Tome0Rosa Gonzalez-Quevedo1Maria Escudeiro dos Santos2Hans Juergen Dornbusch3Sabine Straus4Emer Cooke5Vaccines and Therapies for Infectious Diseases, Human Medicines Division, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The NetherlandsPublic and Stakeholder Engagement Department, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The NetherlandsVaccines and Therapies for Infectious Diseases, Human Medicines Division, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The NetherlandsEuropean Academy of Paediatrics (EAP)/Union of European Medical Specialists—Section of Paediatrics (UEMS-SP), Avenue de la Couronne, 20, B-1050 Brussels, BelgiumVaccines and Therapies for Infectious Diseases, Human Medicines Division, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The NetherlandsEuropean Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The NetherlandsBackground: <i>Neisseria meningitidis</i> B is one of the main causative pathogens of meningitis and other forms of severe meningococcal disease. In the past decade, meningococcal B vaccines have been developed to address this infection and its sequelae. Objective: This article aims to present an example of how the EU regulatory framework allowed the early authorisation of two life-saving vaccines initially based on immunogenicity surrogates of clinical evidence. This was subsequently followed by post-marketing surveillance providing real-world evidence to support their safety profile and impact on the paediatric population in the EU. Methods: We review the evidence supporting the initial regulatory approval of the vaccines, the confirmatory data demonstrating vaccine effectiveness post-authorisation, and the real-world impact of these vaccines on the paediatric population. Results: Two vaccines were approved in the EU for active immunisation to prevent IMD caused by MenB (4CMenB in 2013 and MenB-fHBP in 2017). Both marketing authorisations were based on immunogenicity data (efficacy studies were not feasible due to the rarity of the disease) and safety data generated from pre-authorisation studies. Additional pharmacovigilance activities to further investigate the safety profile and effectiveness studies were requested to be conducted after approval. Both the effectiveness and safety profile of the vaccines were confirmed by these data. Conclusions: This paper illustrates that the EU medicines regulatory framework and safety monitoring system are robust. By supplementing the initial evidence with post-authorisation studies, further effectiveness and safety data enabled regulators to confirm the positive benefit–risk of the vaccines without delaying their access to the people who need them.https://www.mdpi.com/2076-393X/13/7/770invasive meningococcal disease<i>Neisseria meningitidis</i> serogroup Bvaccineregulatory frameworkeffectivenesssafety monitoring system |
| spellingShingle | Maribel Gonzalez Tome Rosa Gonzalez-Quevedo Maria Escudeiro dos Santos Hans Juergen Dornbusch Sabine Straus Emer Cooke Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for Children Vaccines invasive meningococcal disease <i>Neisseria meningitidis</i> serogroup B vaccine regulatory framework effectiveness safety monitoring system |
| title | Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for Children |
| title_full | Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for Children |
| title_fullStr | Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for Children |
| title_full_unstemmed | Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for Children |
| title_short | Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for Children |
| title_sort | meningococcal b vaccines as a paradigm of safe and effective vaccines for children |
| topic | invasive meningococcal disease <i>Neisseria meningitidis</i> serogroup B vaccine regulatory framework effectiveness safety monitoring system |
| url | https://www.mdpi.com/2076-393X/13/7/770 |
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