Bavarian Nordic Gains UK Approval for Chikungunya Vaccine for Ages 12+

7 May 2025
Bavarian Nordic A/S, a company based in Copenhagen, Denmark, has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for VIMKUNYA®, a vaccine designed for active immunization against chikungunya virus in individuals aged 12 and older. This approval was achieved through the international recognition procedure, acknowledging prior approval by the European Commission.

The company plans to launch the vaccine in the UK during the summer of 2025. The vaccine aims to protect UK citizens, particularly travelers to regions in the Americas, Africa, and Asia where the chikungunya virus is prevalent. Paul Chaplin, President and CEO of Bavarian Nordic, noted that the spread of invasive mosquitos carrying the virus in Southern Europe is a growing concern due to climate change. He emphasized the importance of preventative measures such as vaccination in mitigating the impact of diseases like chikungunya.

This approval in the UK marks the third regulatory endorsement for Bavarian Nordic’s chikungunya vaccine, following approvals by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025. Additionally, Bavarian Nordic has submitted for regulatory review in Canada, with potential approval anticipated in the first half of 2026.

Chikungunya is a disease transmitted by mosquitos and caused by the chikungunya virus (CHIKV). Over the past two decades, the virus has spread across regions in Asia, Africa, and the Americas, leading to significant outbreaks. It has been identified in over 110 countries, with active transmission reported in more than 50 countries over the last five years. Symptoms typically include fever, rash, fatigue, headache, and severe joint pain, with most patients recovering within one to two weeks. However, 30-40% of sufferers may develop chronic arthritis lasting months or even years. In 2024, there were 620,000 reported cases worldwide, resulting in over 200 deaths. It is suggested that chikungunya is underreported and often misdiagnosed as dengue fever due to similar symptoms.

VIMKUNYA® is a single-dose, prefilled, adjuvanted VLP recombinant protein vaccine. It is intended for active immunization against the chikungunya virus in individuals aged 12 years and older. The approvals in the US, EU, and UK were based on phase 3 clinical trials involving over 3,500 healthy participants aged 12 and older. The trials demonstrated that 21 days post-vaccination, up to 97.8% of participants developed neutralizing antibodies, with a seroresponse rate of 46.6% at day 8, increasing significantly by day 15. The vaccine was generally well-tolerated with mild or moderate side effects, primarily including pain at the injection site, fatigue, headache, and muscle pain.

Bavarian Nordic is a global vaccine company committed to enhancing health and saving lives through innovative vaccines. They are a preferred supplier of mpox and smallpox vaccines to governments and hold a leading portfolio of travel vaccines.

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