The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Bavarian Nordic’s Vimkunya (recombinant, adsorbed) vaccine for preventing chikungunya virus infection in people aged 12 and above.
Vimkunya also received approvals from the US Food and Drug Administration (FDA) and the European Commission (EC).
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The vaccine’s authorisation in the UK was facilitated by the international recognition procedure, acknowledging the recent EC approval.
Vimkunya’s launch in the country is anticipated by the summer of 2025.
Bavarian Nordic’s chikungunya vaccine application has been submitted for approval to Health Canada, with potential authorisation expected in the first half of 2026.
Designed as a prefilled, single-dose, adjuvanted virus-like particle recombinant protein vaccine, Vimkunya is approved for active immunisation to prevent the virus in these individuals.
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By GlobalDataApprovals in the UK, EU and US were supported by the outcomes from two Phase III trials.
These trials, which involved 3,500 healthy participants, met their primary endpoints, demonstrating the vaccine’s performance in inducing neutralising antibodies in up to 97.8% of the vaccinated subjects, within 21 days post-vaccination.
Vimkunya was found to be tolerated well, with the most common side effects being injection site pain, headache, muscle pain and fatigue, mostly mild or moderate.
Bavarian Nordic CEO and president Paul Chaplin stated: “Chikungunya mostly represents a risk for UK citizens travelling 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.”
In December 2024, the company entered a licence and manufacturing agreement with the Serum Institute of India for its mpox vaccine, MVA-BN.
