The European Commission has expanded Bavarian Nordic’s Imvanex vaccine approval to include children from 2 years old, enhancing protection amid a severe mpox outbreak affecting vulnerable populations in Africa and Europe.
The European Commission has expanded Bavarian Nordic’s Imvanex vaccine to cover children from 2 years old, after the bloc’s medicines regulator backed the move with a positive opinion in June. The decision means the shot, which protects against smallpox, mpox and disease caused by vaccinia virus, is now authorised across the EU for people aged 2 and above. According to the European Medicines Agency, the change follows a type II variation to the product’s marketing authorisation.
The approval rests on phase 2 data from 227 children aged 2 to 11 and adults, with the company saying the study showed immune responses in children were not inferior to those seen in adults and that safety looked similar after two standard doses. Bavarian Nordic submitted the data to the EMA in March, after earlier developing the same vaccine for older groups. The agency had already supported its use in adolescents aged 12 to 17 in 2024, and last year its Emergency Task Force said children were being hit disproportionately hard by the mpox outbreak but that no trial data were yet available for those under 12.
The latest move arrives against the backdrop of a severe clade I mpox outbreak in central Africa, particularly the Democratic Republic of the Congo. EMA figures cited in its emergency guidance said children accounted for a large share of cases and deaths in the outbreak, underscoring why paediatric access matters. In a statement, Bavarian Nordic chief executive Paul Chaplin said the approval was an important step towards widening access to protection for a vulnerable age group.
The company says the authorisation reinforces the evidence base for MVA-BN, the non-replicating vaccine sold as JYNNEOS in the US and IMVAMUNE in Canada. For Europe, the change extends an already broader paediatric rollout and gives regulators a vaccine option for younger children at risk from smallpox- and mpox-related disease.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
