Bavarian Nordic announced that the European Commission has adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation for the approval of a type II variation for IMVANEX® (MVA-BN) smallpox and mpox vaccine, extending the current marketing authorization to include adolescents 12 to 17 years of age.

The CHMP recommendation follows the submission last month to EMA of data from a clinical study sponsored by the U.S. National Institutes of Health’s (NIH) National Institutes of Allergy and Infectious Diseases (NIAID), in 315 adolescents 12-17 years of age and 211 adults aged 18 years and older, demonstrating non-inferiority of the immune responses as well as a similar safety profile between both age groups after vaccination with two standard doses of the MVA-BN vaccine.

Paul Chaplin, President & CEO of Bavarian Nordic, said: “We applaud EMA for their expedited review and decision to recommend approval of MVA-BN for adolescents. This represents an important milestone in our efforts to make our vaccine available for all populations and will help improve access for some of the most vulnerable individuals mostly impacted by the ongoing mpox outbreak in Africa.”

Bavarian Nordic is preparing for a clinical trial to assess the immunogenicity and safety of MVA-BN in children 2-12 years of age, aiming to further extend the indication of the vaccine into younger populations. The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is expected to start next month.