Core Viewpoint - Bavarian Nordic A/S has submitted clinical data to the European Medicines Agency (EMA) to extend the indication of the MVA-BN mpox and smallpox vaccine to include children aged 2 to 11 years, demonstrating a comparable safety profile and non-inferior immune response compared to adults [1][2]. Group 1: Clinical Study Results - The submission is based on positive topline results from a Phase 2 clinical study involving 227 children aged 2-11 years and 224 adults, showing non-inferiority of immune responses and a similar safety profile between both age groups after vaccination with 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, where cases of mpox were reported during recent outbreaks [2]. Group 2: Implications and Statements - The potential extension of the Marketing Authorisation for MVA-BN to include individuals from 2 years of age could occur later in 2026 following EMA's review of the data [3]. - The President and CEO of Bavarian Nordic emphasized the importance of broadening vaccine access for children, who are disproportionately affected by mpox, especially in the context of ongoing health challenges [4]. - CEPI's Mpox Disease Programme Lead highlighted that children face a higher risk of severe disease during outbreaks, underscoring the need for expanded vaccine access for this vulnerable population [4]. Group 3: Vaccine Information - MVA-BN is the only non-replicating mpox vaccine approved in several countries, including the U.S., Switzerland, and the EU, originally developed as a smallpox vaccine to ensure supply for the entire population, including immunocompromised individuals [5]. - The vaccine is indicated for use in the general population from 12 years old for those considered at risk for smallpox or mpox infection [5]. Group 4: 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 [6].