Global pharma powerhouse Bavarian Nordic has submitted clinical data to the European Medicines Agency (EMA) to extend the indication of its MVA-BN mpox and smallpox vaccine to children aged 2 to 11 years.

 

The submission follows positive topline results from a Phase 2 study involving 227 children and 224 adults. The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN. 

 

Conducted in the Democratic Republic of Congo (DRC) and Uganda, and co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the study comes amid reports of mpox cases in both adults and children during recent outbreaks in Africa and globally.

 

If EMA approves, the vaccine could be authorized for children as young as two later in 2026.

 

“The submission of data for children aged 2-11 years to EMA marks another leap in the advancement of our MVA‑BN vaccine to protect populations broadly against mpox and smallpox,” said Paul Chaplin, President and CEO of Bavarian Nordic. 

 

“While the risk of mpox in Africa is now more moderate, children remain disproportionally affected by the disease, highlighting the importance to broaden the access to vaccines and therapies for this vulnerable population. Our collaboration with CEPI and local partners in Africa has been instrumental in generating the data to support this submission, and together we continue our endeavors to ensure access to the vaccine for other vulnerable populations.”

 

Dr. Kristine Rose, Mpox Disease Programme Lead at CEPI, added: “Children have been significantly impacted during recent global outbreaks of mpox, with many facing a higher risk of severe disease compared to adults—especially when other health challenges, such as malnutrition, malaria or HIV, are present. 

 

"This has led to ongoing suffering in the younger populations and continued transmission of the virus, underscoring the need to expand access to vaccines specifically for this age group. Bavarian Nordic’s submission to a WHO listed Authority like the EMA is an important step towards protecting children around the world as, following potential expansion of the vaccine to younger demographics, other regulators could follow suit.”

 

Professor Hypolite Muhindo Mavoko of the University of Kinshasa, principal investigator of the study, emphasized the public health stakes: “In the Democratic Republic of the Congo, children aged 2 to under 12 years represent nearly one-third of the population and are disproportionately affected by mpox complications. 

 

"Because children interact closely with one another and within households, they can also contribute to ongoing transmission. Expanding vaccine access to this age group is therefore an important step to better protect vulnerable populations and strengthen outbreak control, while reducing the health and economic burden associated with mpox.”