{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T04:37:10Z","timestamp":1788583030531,"version":"build-2803163510"},"reference-count":62,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2025,7,21]],"date-time":"2025-07-21T00:00:00Z","timestamp":1753056000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background: Neisseria meningitidis 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\u2013risk of the vaccines without delaying their access to the people who need them.<\/jats:p>","DOI":"10.3390\/vaccines13070770","type":"journal-article","created":{"date-parts":[[2025,7,21]],"date-time":"2025-07-21T10:35:31Z","timestamp":1753094131000},"page":"770","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Meningococcal B Vaccines as a Paradigm of Safe and Effective Vaccines for Children"],"prefix":"10.3390","volume":"13","author":[{"given":"Maribel","family":"Gonzalez Tome","sequence":"first","affiliation":[{"name":"Vaccines and Therapies for Infectious Diseases, Human Medicines Division, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa","family":"Gonzalez-Quevedo","sequence":"additional","affiliation":[{"name":"Public and Stakeholder Engagement Department, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Escudeiro dos Santos","sequence":"additional","affiliation":[{"name":"Vaccines and Therapies for Infectious Diseases, Human Medicines Division, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans Juergen","family":"Dornbusch","sequence":"additional","affiliation":[{"name":"European Academy of Paediatrics (EAP)\/Union of European Medical Specialists\u2014Section of Paediatrics (UEMS-SP), Avenue de la Couronne, 20, B-1050 Brussels, Belgium"},{"name":"Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, 8036 Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Straus","sequence":"additional","affiliation":[{"name":"Vaccines and Therapies for Infectious Diseases, Human Medicines Division, European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands"},{"name":"Pharmacovigilance and Risk Assessment Committee (PRAC), European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emer","family":"Cooke","sequence":"additional","affiliation":[{"name":"European Medicines Agency, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,7,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"521","DOI":"10.1186\/s12889-022-12933-3","article-title":"Epidemiology of invasive meningococcal disease and sequelae in the United Kingdom during the period 2008 to 2017\u2014A secondary database analysis","volume":"22","author":"Guedes","year":"2022","journal-title":"BMC Public Health"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1007\/s40121-018-0213-2","article-title":"Systematic Review of Invasive Meningococcal Disease: Sequelae and Quality of Life Impact on Patients and Their Caregivers","volume":"7","author":"Olbrich","year":"2018","journal-title":"Infect. 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