Bavarian Nordic A/S has announced that the European Commission has approved an extension of the Marketing Authorisation for Imvanex (MVA-BN), allowing the smallpox and mpox vaccine to be used in children aged 2 to less than 12 years.

The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and expands the approved age range of MVA-BN in the European Union to individuals aged 2 years and older.

The approval is supported by data from a Phase 2 clinical study (NCT06549530) involving 227 children aged 2 to under 12 years and 224 adults. The study showed that children generated immune responses that were non-inferior to those observed in adults after receiving two standard doses of MVA-BN. The vaccine also demonstrated a similar safety profile across the two age groups. The study was co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

The expanded authorisation provides an additional vaccination option for younger children who may be vulnerable to mpox and smallpox. Children have been disproportionately affected during some recent mpox outbreaks, particularly in parts of Africa, highlighting the importance of expanding access to vaccines for younger populations.

Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said the European Commission’s decision represents an important advancement in expanding access to protection against mpox and smallpox. He also acknowledged the contribution of study participants, investigators, CEPI and other partners involved in generating the clinical evidence supporting the approval.

The decision adds to the clinical evidence supporting MVA-BN across different age groups and strengthens Bavarian Nordic’s efforts to support global public health preparedness and outbreak response.

MVA-BN, also known as Modified Vaccinia Ankara-Bavarian Nordic, is a non-replicating vaccine developed initially as a smallpox vaccine in collaboration with the US government. Its development was aimed at providing a smallpox vaccination option, including for immunocompromised individuals who are not recommended to receive traditional replicating smallpox vaccines.

The vaccine is approved for use in several markets, including the United States, Switzerland, Singapore, Mexico, Canada, the European Union/European Economic Area and the United Kingdom, under different brand names including Jynneos, Imvamune and Imvanex.

With the latest European approval, MVA-BN is authorised for individuals aged 2 years and older in the EU, broadening the potential reach of vaccination programmes targeting mpox and smallpox and supporting preparedness for future outbreaks.

Bavarian Nordic is a global vaccine company focused on developing and supplying vaccines for infectious diseases. The company is a preferred supplier of mpox and smallpox vaccines to governments and also maintains a portfolio of travel vaccines.