The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bavarian Nordic’s Vimkunya (recombinant, adsorbed) to prevent disease caused by the chikungunya virus in individuals aged 12 years and older.
Chikungunya is a mosquito-borne viral disease that causes fever, rash, severe joint pain, headache and fatigue. Symptoms typically resolve within one to two weeks, but up to 40% of patients may develop chronic arthritis that can last for months and sometimes years.
The virus has now been identified in more than 110 countries in Europe, Asia, Africa and the Americas, including many popular travel destinations, with 620,000 cases reported worldwide in 2024.
The MHRA’s decision on Vimkunya, which Bavarian Nordic expects to launch this summer, occurred through the International Recognition Procedure, a fast-track approval process that takes into account prior authorisations from other regulatory partners.
Among the evidence supporting the approval were results from two late-stage 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.
Bavarian Nordic’s president and chief executive officer, Paul Chaplin, said: “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 mosquitoes known to carry the disease have established themselves in many parts of Southern Europe and are moving further north due to climate change.
“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 approval comes three months after the MHRA approved Valneva’s chikungunya vaccine Ixchiq for use in individuals aged 18 years and older. The company has already submitted a label extension application in the UK to potentially expand the use of the vaccine to adolescents aged 12 to 17 years.