Bavarian Nordic said Tuesday its mpox and smallpox vaccine produced a strong immune response and was well-tolerated in children aged 2 to 11 in a clinical study.
The Danish vaccine maker reported that the study met its primary goal, showing an immune response in children that was not only comparable to adults but 2.5 times higher.
The safety profile in the pediatric population was similar to that observed in adults, with no unexpected signals, according to the company.
Bavarian Nordic plans to use the data to apply for an extension of the vaccine's European approval in 2026 to include children as young as two.
The vaccine, marketed as Imvanex in Europe, is currently approved for individuals aged 12 and older.
"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 2-11 years," said Paul Chaplin, President and CEO of Bavarian Nordic.
The positive trial results come as Bavarian Nordic is in the process of being acquired by a private equity consortium led by Nordic Capital and Permira.
The vaccine is a key product for the company, which supplies it to governments for public health stockpiles amid an ongoing mpox outbreak in Africa.
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