The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revoked approval for Valneva’s chikungunya vaccine after deciding that the jab’s risks outweigh its benefits in preventing the tropical disease.
The withdrawal follows a review of the post-marketing data and a consultation with the Commission on Human Medicines (CHM), which acts as an expert advisory committee to the MHRA.
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In a notice, the MHRA stated: “The benefit-risk balance for the Ixchiq chikungunya vaccine is no longer considered favourable.”
Healthcare professionals are no longer allowed to prescribe, supply or administer the French company’s vaccine, and any remaining stocks should be disposed of.
In a statement, Valneva said it “disagrees with the CHM’s and MHRA’s conclusion”, though said it would not appeal the decision. Instead, the company will focus on continuing to expand the vaccine’s access in endemic territories.
The move means the UK now only has one approved chikungunya vaccine – Bavarian Nordic’s Vimkunya.
Caused by its namesake virus, chikungunya is a mosquito-borne disease mainly found in tropical regions. Although cases are not prevalent in North America or Europe, there is a risk of disease transmission to travellers visiting outbreak-affected countries in Africa and South America, along with islands in the Indian and Pacific Oceans. The MHRA stated that those travelling to affected regions will now need to use an “alternate vaccine”.
Shares in Paris-listed Valneva were largely unchanged at market open on 20 October, suggesting limited financial impact due to a relatively small UK market. Bavarian Nordic’s stock rose 0.5% at market open following the news.
Ixchiq secured its first approval in the US in November 2023. At the time, it became the only licensed vaccine against chikungunya. The live attenuated vaccine subsequently won authorisation in Europe and the UK in June 2024 and February 2025, respectively.
Since coming to market, however, the product has been plagued by safety concerns. There have been adverse events (AEs) reported in individuals who received the vaccine, including three deaths. As per analyses, Ixchiq can causing chikungunya-like illness in vaccine recipients, as well as rare neurological events such as encephalitis. Global regulators initiated respective reviews into the appropriateness of the vaccine’s place on the market.
In August last year, the US Food and Drug Administration (FDA) suspended Ixchiq’s license, citing “serious safety concerns related to the vaccine”. In a statement, Valneva said it was mandated to stop shipping and selling Ixchiq in the country.
The MHRA had already restricted Ixchiq’s use to certain age groups shortly after approval, though the marketing authorisation withdrawal means the jab’s use has been fully banned. The vaccine remains available in Europe, though with narrowed access.
