COPENHAGEN, Denmark, August 7, 2026
Bavarian Nordic announced that the European Commission (EC) has approved a Type II variation extending the marketing authorization for IMVANEX® (MVA-BN) to include children aged 2 to less than 12 years. The expanded approval authorizes the non-replicating vaccine for protection against mpox, smallpox, and disease caused by vaccinia virus, significantly broadening access to pediatric vaccination across the European Union. The decision follows the recent positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) and strengthens MVA-BN’s role in supporting global outbreak preparedness. With this latest authorization, the vaccine is now approved in the EU for individuals aged two years and older, representing an important milestone in protecting children who remain vulnerable during mpox outbreaks.
Phase 2 Study Demonstrated Strong Immune Response and Safety
The European Commission’s approval was supported by data from a Phase 2 clinical trial (NCT06549530) involving 227 children aged 2 to less than 12 years and 224 adults. The study demonstrated that children vaccinated with two standard doses of MVA-BN developed non-inferior immune responses compared with adults while maintaining a similar safety profile. These findings confirmed that the vaccine performs consistently across pediatric and adult populations, providing regulators with evidence supporting expanded use in younger children. The study was co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI), highlighting the continued collaboration between public health organizations and vaccine developers to improve preparedness against emerging infectious diseases.
Expanded Pediatric Access Strengthens Global Outbreak Preparedness
The expanded authorization comes as children have experienced a disproportionate impact during recent mpox outbreaks, particularly in parts of Africa, emphasizing the need for safe and effective preventive vaccines. According to Bavarian Nordic, the approval reflects years of clinical development aimed at expanding access to MVA-BN across all eligible age groups. Company President and Chief Executive Officer Paul Chaplin noted that extending vaccine availability to younger children represents an important advancement in protecting vulnerable populations while supporting global efforts to strengthen infectious disease preparedness. The approval also adds to the growing body of evidence supporting the vaccine’s effectiveness and safety across diverse populations, reinforcing its importance in future outbreak response strategies.
Advertisement
MVA-BN Continues to Expand Its Global Regulatory Footprint
MVA-BN remains the only non-replicating mpox vaccine approved across multiple international markets, including the United States, European Union, United Kingdom, Canada, Switzerland, Singapore, and Mexico, where it is marketed under the brand names IMVANEX®, JYNNEOS®, and IMVAMUNE® depending on the region. Originally developed as a smallpox vaccine in collaboration with the U.S. government, the vaccine was specifically designed to provide protection for the general population, including immunocompromised individuals who are not suitable candidates for traditional replicating smallpox vaccines. The latest European Commission approval further reinforces Bavarian Nordic’s leadership in the global vaccine market while strengthening international public health preparedness against mpox, smallpox, and related orthopoxvirus diseases through broader pediatric immunization access.
Source:Bavarian Nordic, press release
