The European Commission has authorised the use of Bavarian Nordic’s Imvanex vaccine for children aged 2 to under 12, aiming to bolster protection against mpox, smallpox, and vaccinia virus disease amid ongoing outbreaks impacting vulnerable populations, especially in Africa.
The European Commission has authorised Bavarian Nordic’s Imvanex vaccine for children aged 2 to under 12, extending protection against mpox, smallpox and vaccinia virus disease across the EU and European Economic Area. The decision, announced on August 7, follows a recommendation from the European Medicines Agency’s human medicines committee in late June and fills a major gap for countries struggling to protect young children in the current outbreak.
The move matters most far beyond Brussels. In the Democratic Republic of Congo, children under 15 account for roughly 60% of confirmed cases and about 80% of reported deaths, according to UNICEF data cited in the lead report. Health officials have been grappling with an epidemic in which the youngest patients are often the most vulnerable, particularly where malnutrition and HIV exposure weaken immune defences.
Until now, Imvanex had been cleared in the EU only for adults and, from 2024, adolescents aged 12 to 17, according to the EMA. The new approval was backed by a phase 2 study in the Democratic Republic of Congo and Uganda involving children and adults exposed to active transmission. Bavarian Nordic said the children’s immune response was non-inferior to that of adults after two doses, with no unexpected safety signals.
The technical feature that makes the vaccine especially important is that it is non-replicating. Unlike older live smallpox vaccines, it cannot reproduce inside human cells, which is why it is better suited to children who may already be immunocompromised. The World Health Organisation has said MVA-BN may be used off-label for children in emergencies, but until this EU decision there was no formal paediatric authorisation below age 12.
Even so, regulatory clearance does not automatically solve access. The lead report said vaccine supply, cold chain limits and weak health systems have all slowed delivery in the Democratic Republic of Congo and elsewhere in Africa. The authorisation may help unlock wider procurement through international agencies, but getting doses to the children who need them most remains the harder task.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
