The European Commission has authorised the use of Bavarian Nordic’s Imvanex vaccine for children aged 2 to under 12, marking a significant advancement in protective measures against mpox and smallpox across the EU amid ongoing public health concerns.
Bavarian Nordic said on Thursday that the European Commission has approved its Imvanex vaccine for children aged 2 to under 12, widening use of the shot across the bloc as health authorities look to strengthen protection against mpox and smallpox. The decision follows a positive opinion from the European Medicines Agency’s human medicines committee and extends the medicine’s existing authorisation to a younger age group.
The approval is based on a phase 2 study involving 227 children and 224 adults, which found that children generated an immune response no worse than that seen in adults and showed a similar safety profile after two standard doses. The study was partly funded by the Coalition for Epidemic Preparedness Innovations and was carried out in the Democratic Republic of Congo and Uganda, where mpox cases have affected both adults and children during the latest outbreak in Africa.
The European Medicines Agency had previously warned that children under 12 were at greater risk of severe mpox and noted in 2024 that no vaccine was authorised for that age group in the European Union. It also pointed to planned trials in younger children after the World Health Organisation declared mpox a public health emergency of international concern in August 2024. In September 2024, the WHO’s vaccine advisers said Imvanex could be used off-label in outbreak settings when the benefits outweighed the risks.
With the latest ruling, Bavarian Nordic said MVA-BN is now authorised in the EU for people from age 2 onwards. The company described the move as an important step in widening access to a non-replicating vaccine, meaning one that cannot reproduce in the body, for use against mpox, smallpox and disease caused by vaccinia virus. The Danish group also said the decision reinforces its role in supporting global outbreak preparedness.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
