Brussels, 20 September 2024
The EU Commission has extended the authorisation of the Imvanex vaccine to adolescents aged 12 to 17 years. Imvanex is the only Mpox vaccine currently authorised in the EU, together with an antiviral treatment (Tecovirimat SIGA). The authorisation follows a recommendation from the European Medicines Agency (EMA), which considered the vaccine to be effective and safe in this age group.
It was first authorised in the EU in 2013 to protect adults against smallpox, with the authorisation extended in 2022 to protect adults against Mpox and vaccinia virus disease. Given the importance of the vaccine, particularly for Africa, the EMA gave high priority to assessing the extension of the authorisation of the vaccine to adolescents, and the Commission authorised the vaccine through an accelerated decision-making process. EMA is working with African regulators to advance vaccine authorisations 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 step forward that adolescents aged 12 to 17 can now be protected against Mpox with a safe and effective vaccine. While the overall risk of becoming infected with Mpox for the general population in the EU remains low, we are working continuously at EU level to ensure adequate preparedness. Together with the European Centre for Disease Prevention and Control (ECDC), we will continue to work with Member States, the World Health Organization (WHO), the African Union, including the Africa Centre for Disease Control and Prevention (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.”
Source – EU Commission (e-translated from the French version)