European Commission Approval of Mpox/Smallpox Vaccine for Children Aged 2 to Less than 12 Years – Bavarian Nordic

Bavarian Nordic A/S announced that the European Commission has adopted the recent Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the approval of a type II variation for IMVANEX (MVA-BN) smallpox and mpox vaccine, extending the current marketing authorization to include children 2 to less than 12 years of age.

The approval is based on data from a Phase II clinical study (NCT06549530) involving 227 children aged 2 to <12 years and 224 adults, demonstrating non-inferior immune responses and a similar safety profile in children compared to adults following vaccination with two standard doses of MVA-BN. The study was co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

With this approval, MVA-BN is now authorized in the European Union for use in individuals aged 2 years and older, marking a significant expansion of access to a non-replicating vaccine designed to help protect vulnerable populations against mpox, smallpox and disease caused by vaccinia virus.

Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said: “The European Commission’s approval of MVA-BN for children aged 2 to less than 12 years represents an important advancement in our efforts to broaden access to protection against mpox and smallpox. Children have carried a disproportionate burden during recent mpox outbreaks, particularly in parts of Africa, underscoring the importance of making safe and effective vaccines available to this vulnerable population. We are grateful to the study participants, investigators, CEPI and our partners whose collaboration helped generate the data supporting this approval.”

The approval adds to the growing body of clinical evidence supporting the use of MVA-BN across age groups and further strengthens Bavarian Nordic’s commitment to supporting global public health preparedness and outbreak response.