UK MHRA Reviews Chikungunya Vaccine

The application was submitted to MHRA in February 2025 under the international recognition procedure based on the positive opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency in January 2025. CHIKV VLP vaccine was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025 under the trade name Vimkunya, and could potentially obtain approval in the UK later in the first half of 2025.

Bavarian Nordic recently expanded its global commercial presence to include a dedicated UK-based organization to manage its travel health portfolio, also comprising vaccines for rabies, typhoid and cholera. The Company is also a supplier of mpox vaccines to the UK Health Security Agency (UKHSA).

“Following the approvals of our chikungunya vaccine in the US and EU last month, we are excited about the opportunity to expand its availability to European countries later this year.” said Paul Chaplin, President and CEO of Bavarian Nordic. “With our recent organizational expansion into the UK, we are strongly positioned to leverage synergies across our growing travel health portfolio in the launch of the chikungunya vaccine for travelers, including those aged 12-17 years, pending approval by the MHRA.”

The US and EU approvals of Vimkunya (CHIKV VLP vaccine) were based on results from two phase III clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals and demonstrated a rapid immune response starting to develop within one week. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature.