Commission extends authorisation of Mpox vaccine to adolescents

The Commission has extended the authorisation of the Imvanex vaccine for use in adolescents aged 12 to 17 years. Imvanex is the only vaccine against Mpox currently authorised in the EU, together with one antiviral treatment (Tecovirimat SIGA). The authorisation follows a recommendation from the European Medicines Agency (EMA), which assessed the vaccine to be effective and safe for this age group.

It was first authorised in the EU in 2013 to protect adults from smallpox, with the authorisation extended in 2022 to protect adults from Mpox and disease caused by the vaccinia virus. Given the importance of the vaccine, in particular for Africa, EMA has given high priority to the assessment of the extension of the authorisation of the vaccine to adolescents, and the Commission authorised the vaccine using an accelerated decision-making process. The EMA is working with African regulators to advance authorisations of the vaccine in the African region to support the response to the outbreak in the region.

Stella Kyriakides, Commissioner for Health and Food Safety, said: “It is an important development that adolescents aged 12 to 17 can now also be protected against Mpox with a safe and efficient vaccine. 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 ECDC, we will continue to work with the Member States, the WHO, the African Union, including the Africa CDC, and other local and international partners to help control the spread of Mpox on the African continent. It is only through global cooperation that we can overcome health emergencies.”