Bavarian Nordic Reports Positive Topline Data for Mpox/Smallpox Vaccine in Pediatric Population
October 7, 2025
Bavarian Nordic’s new clinical study marks a critical advancement in mpox prevention for children. Conducted in the Democratic Republic of the Congo and Uganda, the MVA-BN vaccine trial demonstrated that children aged 2–11 generated stronger immune responses than adults, with no unexpected safety issues. These findings pave the way for extending vaccine approval to younger populations, offering vital protection in regions hardest hit by ongoing outbreaks. With CEPI’s support, the results could transform pediatric mpox prevention and strengthen public health resilience in Africa and beyond. Pending regulatory review, this development represents meaningful progress toward broader global vaccine equity.
Bavarian Nordic’s topline results from its pediatric clinical trial of the MVA-BN mpox/smallpox vaccine mark an important milestone in global outbreak preparedness and child health protection. The Phase III study, co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI), enrolled 460 participants across the Democratic Republic of the Congo and Uganda. It compared immune responses between children aged 2–11 and adults aged 18–50.
The results showed that two weeks after receiving two standard doses, children’s immune responses were not only non-inferior but significantly stronger than those of adults, with neutralizing antibody titers 2.5 times higher. The vaccine was well tolerated, with no safety concerns or unexpected signals, reaffirming its suitability for pediatric use. Bavarian Nordic plans to submit these findings to the European Medicines Agency in 2026 to extend MVA-BN’s approval to children as young as 2 years old.
Currently approved in Europe for individuals aged 12 and older, MVA-BN has already proven instrumental in controlling mpox outbreaks among adults. Extending this protection to younger children could fill a major gap in regions like Africa, where mpox remains a persistent and deadly public health threat. In the Democratic Republic of the Congo, for instance, mpox continues to cause severe illness and mortality, particularly among children.
Paul Chaplin, Bavarian Nordic’s CEO, emphasized that this data “brings us one step closer to approval” for pediatric use, providing “an even stronger tool in the public health response.” CEPI’s Head of Clinical Development Science, Nina Wressnigg, echoed the significance, noting that expanded licensure would help control mpox in countries where children are disproportionately affected.
If approved, MVA-BN’s expanded indication could reshape mpox control strategies, ensuring that one of the most at-risk populations—young children—finally gains access to safe, effective vaccination against this enduring global health emergency.