Bavarian Nordic, with its subsidiary located in Planegg/Munich, has received marketing authorization from the European Commission for VIMKUNYA® for active immunization against Chikungunya virus disease in individuals aged 12 years and older in Europe. The company plans to launch the vaccine in key European markets during the first half of 2025.
This single-dose, virus-like particle (VLP) vaccine is the first Chikungunya vaccine approved in Europe for individuals aged 12 and above. The authorization, which applies across all EU member states as well as Iceland, Liechtenstein, and Norway, marks the second approval of VIMKUNYA® following its recent approval by the U.S. Food and Drug Administration (FDA) earlier this month.
Bavarian Nordic has also recently submitted a marketing authorization application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), with approval anticipated in the first half of 2025. Simultaneously, VIMKUNYA® will be introduced in key European markets within the same timeframe.
The European Commission’s approval was based on the recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025. The decision was supported by data from two Phase 3 clinical trials involving over 3,500 healthy individuals aged 12 years and older. Both studies met their primary endpoints, demonstrating that the vaccine induced neutralizing antibodies in up to 97.8% of vaccinated individuals within 21 days and showed a rapid immune response beginning within one week of vaccination.