The European Commission (EC) has extended the marketing authorisation for Bavarian Nordic’s smallpox and mpox vaccine to include adolescents aged 12 to 17 years.
Imvanex (MVA-BN) is already approved in the EU to protect adults against smallpox, mpox and disease caused by the vaccinia virus.
The EC’s decision follows a recommendation from the European Medicines Agency’s (EMA) human medicines committee and was supported by interim results from a study comparing the vaccine’s ability to generate an immune response in 315 adolescents and in 211 adults.
The trial demonstrated non-inferiority of the immune responses as well as a similar safety profile between both age groups following vaccination with two standard doses.
More than 120 countries have confirmed over 103,000 cases of mpox since the global outbreak began in 2022, while smallpox was officially declared eradicated in 1980.
Imvanex was originally developed as a smallpox vaccine in collaboration with the US government and contains a weakened form of the vaccinia virus, which is closely related to both viruses.
The EMA gave high priority to its assessment of Imvanex for adolescents and is now working with African regulators to advance authorisations of the vaccine to support the response to the outbreak in the region.
Stella Kyriakides, EU commissioner for health and food safety, said: “While the overall risk of getting infected with mpox for the general population in the EU remains low, we are continuously working at EU level to ensure preparedness.
“Together with the European Centre for Disease Prevention and Control, we will continue to work with the member states, the World Health Organization, the African Union, including the Africa Centres for Disease Control and Prevention, and other local and international partners to help control the spread of mpox on the African continent.”
Also commenting on the authorisation, Bavarian Nordic’s president and chief executive officer, Paul Chaplin, said: “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.”
The company said it is aiming to further extend the indication of Imvanex into younger populations and is preparing for a clinical trial to assess the vaccine in children aged two to 12 years.