Bavarian Nordic has announced encouraging topline results from a clinical trial assessing its MVA-BN mpox/smallpox vaccine in children aged between two and 11 years.
The trial involved 460 participants across two cohorts, examining the immunogenicity and safety of two standard vaccine doses in both paediatric and adult populations aged 18–50 years.
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It was jointly funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and took place at various locations in the Democratic Republic of Congo and Uganda.
Findings from 451 evaluable participants indicated that the immune response in children, measured two weeks after the second vaccination, was not inferior to that observed in the adult group.
The trial involved 227 children and 224 adults, with the significant immune responses noted in children aged two to five years.
The immune response in this age group was found to be 2.5-times greater than that of adults, as evidenced by the neutralising antibody titres, while also exhibiting a similar safety profile.
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By GlobalDataBavarian Nordic president and CEO Paul Chaplin said: “Mpox remains a major public health threat, particularly in Africa, where the disease is widespread. While vaccination efforts have significantly improved, certain populations remain highly vulnerable, including younger children.
“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.”
The vaccine was observed to be well tolerated among the paediatric population, with no unexpected safety signals reported. The immunogenicity and safety data for MVA-BN in adults were found to be comparable to historical data.
The company intends to submit the final trial data to the European Medicines Agency in 2026 to support an extension of approval for children aged two years and above.
At present, the MVA-BN vaccine has received approval from the European Commission for use in subjects aged 12 years and older.
