The European Commission has approved a label extension for Imvanex (MVA-BN), Denmark-based Bavarian Nordic's (OMX: BAVA) non-replicating smallpox and mpox vaccine, expanding its authorized use to children aged 2 to less than 12 years. The decision converts a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) — as previously reported — into a binding marketing authorization across the EU, making MVA-BN now authorized for all individuals aged 2 years and older in the region.
Children have been disproportionately affected during recent mpox outbreaks, particularly across parts of Africa, where clade Ib transmission has driven sustained community spread. Prior to this approval, the EU authorization covered individuals aged 12 and older, leaving younger children without a formally approved option. The extension addresses that gap directly, providing a regulatory pathway for vaccination in a population that had previously been excluded from the label despite documented exposure risk.
Bavarian Nordic Chief Executive Paul Chaplin said children had "carried a disproportionate burden during recent mpox outbreaks," and described the approval as an important step in broadening access to the vaccine for a vulnerable population.
The approval is structured as a type II variation to the existing marketing authorization. MVA-BN is administered as a two-dose subcutaneous regimen. No modified dosing schedule for the pediatric age group was reported in the company's announcement; the approval is based on two standard doses, the same regimen used in adults.
MVA-BN is a live attenuated, non-replicating viral vaccine derived from the Modified Vaccinia Ankara strain. Because it cannot complete replication in human cells, it produces viral antigens sufficient to prime orthopoxvirus-specific humoral and cellular immunity without the replication-associated adverse effects associated with earlier smallpox vaccines. This profile makes it suitable for immunocompromised individuals — a population for whom traditional replicating vaccinia vaccines are contraindicated.