Bavarian Nordic Reports Positive Topline Data for Mpox/Smallpox Vaccine in Pediatric Population

• Primary endpoint was met in clinical study, demonstrating a comparable safety profile and a non-inferior immune response for MVA-BN in children aged 2-11 years compared to adults.
• Results will support filing for label extension with EMA in 2026.

COPENHAGEN, Denmark, October 7, 2025 – Bavarian Nordic A/S (OMX: BAVA) today reported topline results from a clinical study of its MVA-BN mpox/smallpox vaccine in children 2 to 11 years of age.

The study (NCT06549530) enrolled 460 individuals in two cohorts: children aged 2-11 years and adults aged 18-50 years with the purpose of comparing safety and immunogenicity of two standard doses of the MVA-BN vaccine between the pediatric and the adult populations. The study was co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at sites in the Democratic Republic of Congo (DRC) and Uganda.

Topline results from the study, comprising 451 individuals evaluable for the primary endpoint, showed that the immune response in children (n=227) two weeks after the second vaccination with MVA-BN was non-inferior to the adult group (n=224), with the highest immune responses observed in the youngest subgroup of children aged 2-5 years. While the safety and immunogenicity generated from this study in adults were comparable to historical data with MVA-BN, the immune response in children was 2.5 times higher than in the adult group as demonstrated by neutralizing antibody titers. The vaccine was generally well tolerated in the pediatric population, with a safety profile similar to adults and no unexpected signals.

Pending final results from the study, Bavarian Nordic plans to submit the data to the European Medicines Agency (EMA) in 2026 to support an extension of the vaccine’s approval to include children aged 2 years and older. MVA-BN is currently approved by the European Commission for individuals aged 12 years and older.

The findings could also expand the use of the vaccine to children in countries severely affected by the current mpox outbreak surging in Africa, with cases also reported in other countries around the world.

Paul Chaplin, President & CEO of Bavarian Nordic, said: “Mpox remains a major public health threat, particularly in Africa, where the disease is widespread. While vaccination efforts have significantly improved, certain populations remain highly vulnerable, including younger children. With the support from CEPI and local partners in Africa, we have now shown MVA-BN to be well-tolerated and to generate a robust and clinically relevant immune response in this population, bringing us one step closer to approval of our vaccine for children aged 2-11 years. This will significantly strengthen the profile of the vaccine and provides an even stronger tool in the public health response to current and future mpox outbreaks.”