Bavarian Nordic A/S recently reported topline results from a phase 2 clinical study of its MVA-BN® (JYNNEOS®) mpox/smallpox vaccine in children 2 to 11 years of age.
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's safety profile is similar to that of adults and has no unexpected signals.
Nina Wressnigg, Head of Clinical Development Science at the Coalition for Epidemic Preparedness Innovations (CEPI), commented in a press release on October 7, 2025, "Mpox has been raging across Africa for over a year and remains a declared continental health emergency."
"Although MVA-BN has been licensed for emergency use in children in the Democratic Republic of the Congo (DRC) - the worst-affected country - many other countries lack this access, causing children to continue to bear the brunt of the suffering, marked by severe illness and possible loss of life.
"These new topline data provide additional positive findings that could expand licensure to children in more countries to control the ongoing outbreak."
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.
The European Commission currently approves MVA-BN 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.
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore, Mexico, Canada (IMVAMUNE®), the EU/EAA, and the United Kingdom (IMVANEX®).
In the United States, JYNNEOS is commercailly available at clinics and pharmacies.
Recently, the Chicago Department of Public Health reported 104 cases of Mpox have been confirmed in 2025. This data is more cases than were reported over the same time period in 2023 (40) and 2024 (53) combined.
The study was co-funded by the CEPI and was conducted at sites in the DRC and Uganda.