The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has formally recommended extending the indication of Bavarian Nordic's Imvanex vaccine to protect adolescents aged 12 to 17 years against smallpox, mpox, and disease caused by vaccinia virus. Previously authorized across the European Union exclusively for adults aged 18 and older, the live modified vaccinia Ankara (MVA-BN) vaccine is marketed as Jynneos in the United States and Imvamune in Canada.
Following the CHMP's positive scientific opinion in Amsterdam, the recommendation advances to the European Commission for a legally binding EU-wide marketing authorization decision. Public health officials emphasized that broadening the age indication equips national health ministries across the 27 EU member states—as well as international regulatory partners relying on EMA assessments—with a critical preventive option for younger populations.
Clinical Immunogenicity Data and Adolescent Safety Assessment
The committee's regulatory endorsement was anchored by interim results from a National Institutes of Health (NIH)-sponsored clinical study evaluating the vaccine's safety and immunogenicity in 315 adolescents aged 12 to 17 compared with 211 adults aged 18 to 50. Researchers confirmed that two standard doses of the MVA-BN vaccine generated neutralizing antibody titers in adolescents that were non-inferior to those observed in adults.
Safety monitoring throughout the trial demonstrated that the adolescent tolerability profile closely mirrored that of adults, with mild-to-moderate injection site pain, fatigue, and headache reported as the primary transient side effects. As part of its regulatory review, the EMA requested that Bavarian Nordic submit final long-term follow-up data from the study by May 2025 to further characterize post-vaccination reactogenicity in youth.
“Extending the authorization of Imvanex to adolescents aged 12 to 17 provides national public health authorities across Europe and partner nations with a vital tool to protect younger populations.”
Strengthening Global and European Preparedness Against Clade Ib Mpox
The expanded authorization carries major implications beyond Europe's borders, particularly in the Democratic Republic of the Congo (DRC) and neighboring East and Central African nations confronting the spread of the Clade Ib mpox strain. Unlike the 2022 global outbreak that predominantly affected adults, recent epidemiological surveillance in Central Africa has documented significant household and community transmission among children and teenagers.
Because the World Health Organization (WHO) and African national regulatory authorities closely coordinate with the EMA on vaccine prequalification and emergency deployment, the CHMP's assessment paves the way for UNICEF, Gavi, and the Africa Centres for Disease Control and Prevention (Africa CDC) to include adolescents in targeted immunization campaigns. Bavarian Nordic has pledged to scale manufacturing capacity to deliver millions of doses through 2025.
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