Core Insights - Bavarian Nordic A/S reported topline results from a clinical study of its MVA-BN mpox/smallpox vaccine in children aged 2 to 11 years, indicating a strong immune response and safety profile comparable to adults [1][3][9] Study Details - The clinical study (NCT06549530) enrolled 460 individuals, including children aged 2-11 years and adults aged 18-50 years, to compare the safety and immunogenicity of two standard doses of the MVA-BN vaccine [2] - The study was co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in the Democratic Republic of Congo and Uganda [2] Results Summary - Among 451 evaluable individuals, the immune response in children (n=227) two weeks post-vaccination was non-inferior to that of adults (n=224), with the highest immune responses in the youngest subgroup (2-5 years) [3] - The immune response in children was 2.5 times higher than in adults, as shown by neutralizing antibody titers, and the vaccine was well tolerated with a safety profile similar to that of adults [3] Future Plans - Bavarian Nordic plans to submit the study data to the European Medicines Agency (EMA) in 2026 to seek approval for the vaccine's use in children aged 2 years and older [4] - Currently, MVA-BN is approved for individuals aged 12 years and older in the European Commission [4] Public Health Implications - The findings could expand the vaccine's use in children in countries severely affected by the ongoing mpox outbreak, particularly in Africa [5] - The CEO of Bavarian Nordic emphasized the importance of the vaccine in protecting vulnerable populations, including younger children, against mpox [6] Vaccine Background - MVA-BN is the only non-replicating mpox vaccine approved in several countries, including the U.S. and EU, originally developed as a smallpox vaccine [7] - The vaccine is indicated for use in the general population from 12 years old, particularly for those at risk of smallpox or mpox infection [7] Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines and is a preferred supplier of mpox and smallpox vaccines to governments [8]