Bavarian Nordic wins EC approval of mpox vaccine for young children
Bavarian Nordic has secured European Commission approval to extend the marketing authorisation of its IMVANEX vaccine to children aged 2 to less than 12 years, covering protection against mpox, smallpox and disease caused by vaccinia virus. The decision, announced on 7 August 2026, follows a positive opinion from the Committee for Medicinal Products for Human Use and broadens the vaccine's EU-authorised age range to cover anyone from 2 years old upwards.
The approval is supported by data from a Phase 2 study (NCT06549530) enrolling 227 children and 224 adults. Results showed non-inferior immune responses in children compared with adults after two standard doses of MVA-BN, alongside a comparable safety profile. The Coalition for Epidemic Preparedness Innovations co-funded the study, reflecting the broader international interest in securing paediatric coverage ahead of future outbreaks.
Why paediatric coverage matters
Chief executive Paul Chaplin noted that children have carried a disproportionate burden during recent mpox outbreaks, particularly in parts of Africa. That observation is borne out by surveillance data from the 2022 to 2024 multi-country outbreaks and the ongoing clade Ib epidemic in central and eastern Africa, where paediatric cases have represented a sizeable share of reported infections and deaths. The absence of a licensed paediatric vaccine had been a recognised gap in the public health response, and the EC decision closes that gap for EU member states.
MVA-BN, or Modified Vaccinia Ankara-Bavarian Nordic, is a non-replicating vaccine, a property that makes it suitable for immunocompromised individuals who cannot safely receive traditional replicating vaccinia-based vaccines. That design distinction has been central to its adoption by governments as a stockpile asset for both mpox and smallpox preparedness.
Regulatory landscape and competitive context
The product is already authorised across a wide range of markets under several trade names: JYNNEOS in the United States, IMVAMUNE in Canada and IMVANEX in the EU, UK and Switzerland. Bavarian Nordic holds a dominant commercial position in the non-replicating mpox and smallpox vaccine segment, with no directly comparable approved competitor in its class across major markets.
Regulatory read-across from the EC decision is relevant for other jurisdictions where MVA-BN holds authorisation but paediatric use has not yet been formally extended. The US FDA authorised JYNNEOS for adults in 2019 and issued emergency use authorisation for adolescents during the 2022 outbreak; a formal paediatric label extension in the US would require a separate regulatory submission supported by the same or equivalent clinical data. Health authorities in the UK and Canada will be watching the EC precedent as they evaluate their own paediatric preparedness positions.
The approval reinforces Bavarian Nordic's strategic positioning as a preferred government supplier for outbreak response, and the company is likely to use the paediatric label to support ongoing tender processes in regions with active mpox transmission.