Danish biotechnology company Bavarian Nordic has received the European Commission (EC) approval for its chikungunya vaccine, Vimkunya, for people aged 12 and older.
Vimkunya is an adjuvanted virus-like particle (VLP) recombinant protein vaccine designed to prevent chikungunya virus infections.
It comprises neutralising antibodies that protect the body against the mosquito-borne disease.
The EC authorisation follows the recent US Food and Drug Administration (FDA) approval.
Vimkunya is the first chikungunya vaccine approved in Europe for this age group, and is valid across all EU member states, along with Iceland, Liechtenstein, and Norway, said the Danish firm.
Bavarian Nordic plans to launch the vaccine in key European markets in the first half of 2025, offered as a suspension for injection in pre-filled syringes.
Bavarian Nordic president and CEO Paul Chaplin said: “We are highly encouraged by the European Commission’s accelerated decision to approve our chikungunya vaccine in Europe, which offers a differentiated profile for travellers, including those as young as 12 years.
“As we expand our presence across Europe, this vaccine will help to further consolidate our leading position in travel vaccines and we look forward to making the vaccine available in key markets during the first half of 2025.”
The EC authorisation follows the European Medicines Agency (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommendation.
It is based on Phase 3 clinical trials in more than 3,500 individuals, aged 12 and older.
In the studies, the vaccine showed that up to 97.8% of participants developed neutralising antibodies 21 days post-vaccination, with a rapid immune response seen within one week.
Chikungunya is caused by the chikungunya virus and presents with symptoms such as fever, rash, fatigue, headache, and severe joint pain.
Furthermore, the Danish company has submitted a Marketing Authorisation Application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), with the approval expected in the first half of this year.
