Bavarian Nordic Seeks Approval to Extend Mpox Vaccine Use to Children

MVA-RNA Danish vaccine manufacturer, Bavarian Nordic, has submitted clinical data to the European Medicines Agency (EMA) seeking approval to extend the use of its mpox and smallpox vaccine to children aged between two and 11 years.

The move, announced on Friday, is based on results from a Phase 2 clinical study which showed that the vaccine, known as MVA-BN, produced an immune response in children comparable to that seen in adults, while maintaining a similar safety profile.

The study involved 227 children aged two to 11 years and 224 adults, all of whom received two standard doses of the vaccine. It was conducted in the Democratic Republic of Congo (DRC) and Uganda—two African countries that recorded cases of mpox among both adults and children during recent outbreaks.

If approved, the vaccine’s authorisation could be expanded later in 2026 to include children as young as two years old.

Chief Executive Officer of Bavarian Nordic, Paul Chaplin, described the submission as a significant step toward broadening protection against mpox and smallpox, particularly among vulnerable populations.

“The submission of data for children aged 2–11 years to EMA marks another leap in the advancement of our MVA-BN vaccine,” Chaplin said. “While the risk of mpox in Africa is now more moderate, children remain disproportionately affected by the disease, highlighting the need to expand access to vaccines and therapies.”

He added that collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) and African partners was crucial in generating the data supporting the application.

Health experts have repeatedly warned that children face a higher risk of severe mpox infection, especially in settings where other health challenges such as malnutrition, malaria and HIV are prevalent.

Echoing this concern, CEPI’s Mpox Disease Programme Lead, Dr Kristine Rose, noted that expanding vaccine access to younger populations is critical in curbing transmission and reducing suffering.

“Children have been significantly impacted during recent global outbreaks of mpox,” she said. “Expanding access to vaccines specifically for this age group is essential, and this submission represents an important step towards protecting children globally.”

Also commenting, Professor Hypolite Muhindo Mavoko of the University of Kinshasa, who led the study in the DRC, said children account for a significant proportion of mpox cases and complications in the country.

“In the DRC, children aged two to under 12 years represent nearly one-third of the population and are disproportionately affected by mpox complications,” he said. “Expanding vaccine access to this group will strengthen outbreak control and reduce the health and economic burden of the disease.”

The MVA-BN vaccine is currently the only non-replicating mpox vaccine approved in multiple jurisdictions, including the United States, European Union, United Kingdom, Canada and Switzerland. It is already authorised for use in individuals aged 12 years and above who are at risk of mpox or smallpox infection.

Mpox, a viral disease that has affected several countries across Africa and beyond in recent years, continues to pose a public health concern, particularly among vulnerable populations.