UK MHRA grants marketing authorization in the UK for Vimkunya vaccine for the prevention of disease caused by chikungunya virus in individuals 12 years and older – Bavarian Nordic

Bavarian Nordic A/S announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for Vimkunya (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognizes approvals from certain other regulatory bodies, in this case the recent approval by the European Commission. Bavarian Nordic is targeting launch of the vaccine in the UK during the summer of 2025.

“Chikungunya mostly represents a risk for UK citizens traveling overseas to affected regions in the Americas, Africa and Asia, but as recent research has shown, invasive mosquitos known to carry the disease have established themselves in many parts of Southern Europe and are moving further north due to climate change,” said Paul Chaplin, President and CEO of Bavarian Nordic. “The mosquitos cannot be stopped, but with preventative measures such as vaccines, we can mitigate the impact of emerging diseases like chikungunya for those at risk, and we look forward to launching our vaccine in the UK later this year.”

The UK approval of Vimkunya marks the third approval of Bavarian Nordic’s chikungunya vaccine, which was approved by the FDA and the European Commission in February 2025. Bavarian Nordic has also submitted an application to Health Canada, potentially supporting approval of the chikungunya vaccine in the first half of 2026.The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase III clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65 year olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12-64 year old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain.