Bavarian Nordic Seeks EMA Nod to Expand Mpox Vaccine to Younger Children
Event summary
- Bavarian Nordic submitted clinical data to the EMA to extend MVA-BN® vaccine approval to children aged 2-11 years.
- Phase 2 study (NCT06549530) in 227 children and 224 adults showed non-inferior immune response and similar safety profile.
- Study co-funded by CEPI and conducted in DRC and Uganda, regions with recent mpox outbreaks.
- EMA review could lead to marketing authorization extension later in 2026.
The big picture
Bavarian Nordic's submission to the EMA reflects a strategic push to broaden the use of its MVA-BN vaccine, addressing a critical gap in protecting children disproportionately affected by mpox. The move aligns with global health priorities to enhance epidemic preparedness, particularly in regions like Africa where mpox remains a significant public health challenge. The collaboration with CEPI and local partners underscores the importance of international cooperation in vaccine development and access.
What we're watching
- Regulatory Timing
- The pace at which EMA reviews and potentially approves the extension for younger children.
- Market Expansion
- Whether other regulators follow EMA's lead in approving the vaccine for children.
- Public Health Impact
- How broader vaccine access for children affects mpox transmission and outbreak control in high-risk regions.