The US Food and Drug Administration (FDA) has approved Bavarian Nordic’s chikungunya vaccine Vimkunya for use in individuals aged 12 years and older.
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 620,000 cases reported globally in 2024.
The mosquito-borne viral disease causes fever, rash, fatigue, headache and often severe joint pain. While the majority of patients make a full recovery, some may develop chronic symptoms that can last for months or even years.
Valneva’s Ixchiq became the world’s first licensed chikungunya vaccine in November 2023 after it was approved by the FDA for use in adults.
However, Bavarian Nordic’s Vimkunya is now the first chikungunya to be approved by the regulator for those as young as 12 years, which the company said “[addresses] an unmet need for chikungunya prevention for younger travellers”.
The FDA’s decision on Vimkunya was supported by positive results from two late-stage clinical trials, in which the vaccine induced neutralising antibodies in up to 97.8% of 3,500 healthy individuals aged 12 years and older 21 days after vaccination. Vimkunya also demonstrated a rapid immune response from as early as week one and was well tolerated across both studies.
Bavarian Nordic’s president and chief executive officer, Paul Chaplin, said: “As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travellers and vulnerable populations.
“We are proud to provide the first vaccine specifically approved for the prevention of chikungunya virus in individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge.”
The company said it is “on track” for the commercial launch of Vimkunya in the US in the first half of 2025.
The authorisation comes less than three weeks after Vimkunya was recommended by the European Medicines Agency’s human medicines committee, also for use in individuals aged 12 years and older.
The European Commission will now review the recommendation as it makes a final decision on the vaccine, which is expected in the coming months.