
Drugmaker Bavarian Nordic yesterday announced encouraging topline results from a clinical trial of its combined mpox/smallpox vaccine in young children.
In a news release, the company said the immune response to the Jynneos (MVA-BN) vaccine in children aged 2 to 11 years, measured 2 weeks after the second dose, was non-inferior to that observed in adults. In children aged 2 to 5, the immune response was 2.5 times greater than observed in adults.
The findings, which have not been peer-reviewed, are from a trial that examined the safety and immunogenicity of the two-dose vaccine in 227 children and 224 adults aged 18 to 50 years. The trial was conducted in locations in the Democratic Republic of the Congo and Uganda, two countries that have been at the epicenter of the mpox outbreak in Africa, and jointly funded by Bavarian Nordic and the Coalition for Epidemic Preparedness Innovations (CEPI).
The vaccine was also well tolerated in children, with no unexpected safety signals reported.
"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 two to 11 years," said Bavarian Nordic President and CEO Paul Chaplin, PhD.
Chaplin noted that though mpox vaccination efforts have improved in Africa, young children remain highly vulnerable to the disease.
Jynneos is currently approved for use in individuals aged 12 and older. Bavarian Nordic said it will submit final trial data to the European Medicines Agency in 2026 to support an extension of approval for children aged 2 and above.