The European Medicines Agency’s human medicines committee has recommended that Bavarian Nordic’s chikungunya vaccine Vimkunya be approved for use in individuals aged 12 years and older.
Chikungunya is a mosquito-borne viral disease that causes fever, rash, fatigue, headache and often severe joint pain. The majority of patients make a full recovery, but some may develop chronic symptoms that can last for months or even years.
The chikungunya virus has emerged across several regions in Asia, Africa and the Americas, including many popular travel destinations, in the past 20 years, with approximately 480,000 cases reported globally in 2024 alone.
The European Commission (EC) has already approved Valneva’s chikungunya vaccine Ixchiq for use in individuals aged 18 years and older, but Bavarian Nordic’s Vimkunya is the first chikungunya vaccine to be recommended by the CHMP for those as young as 12 years.
The committee’s decision was based on positive results from two late-stage clinical trials, in which Vimkunya induced neutralising antibodies in up to 97.8% of 3,500 healthy individuals aged 12 years and older 21 days after vaccination. The vaccine also demonstrated a rapid immune response from as early as week one and was well tolerated across both studies.
The EC will now review the CHMP’s recommendation as it makes a final decision on Vimkunya, which is expected in the coming months.
Bavarian Nordic’s president and chief executive officer, Paul Chaplin, said: “The recommendation of our chikungunya vaccine for approval in Europe marks a huge milestone in our efforts to deliver protection against this debilitating disease and, once approved, would represent a significant contribution to expanding the availability of vaccines to a broader population, including adolescents aged 12 to 17 years.”
Beyond the EU, Vimkunya is also currently under priority review with the US Food and Drug Administration, and an application to the UK Medicines and Healthcare products Regulatory Agency is planned.
“Chikungunya, like other mosquito-borne illnesses, represents an increasing public health risk across the globe due to factors such as climate change, and we look forward to making the vaccine available for travellers at risk later this year, while also continuing our efforts to expand access to endemic populations across the globe,” Chaplin said.