UK Marketing Authorisation for Chikungunya Vaccine IXCHIQ Revoked Following Benefit–Risk Review – Valneva

Valneva SE announced that, following a further benefit-risk assessment of Ixchiq for travelers by the United Kingdom’s (UK) Commission on Human Medicines (CHM), the UK marketing authorization for Ixchiq has been revoked by the Medicines and Healthcare products Regulatory Agency (MHRA).

The decision was based on a review of previous safety data and was not associated with any newly identified safety signal. It does not affect the product licenses for Ixchiq in the EU, Canada, Brazil, or other territories where Ixchiq is currently marketed.

Ixchiq was launched in the UK in mid-2025. Due to low sales amongst travelers, Valneva has not actively distributed Ixchiq in the UK for several months. As no product currently remains on the UK market, Valneva expects no expense related to product recall and only minimal impact on its overall sales revenue going forward.

Valneva considers the benefit-risk profile of Ixchiq favorable when used in accordance with the approved indication, contraindications, warnings and precautions. This is further supported by the emerging post-marketing evidence, including the ongoing pilot vaccination strategy (PVS) in Brazil, where more than 61,000 people aged 18-59 years have been vaccinated to date with no new safety concerns identified. Similar safety reviews were concluded recently by the European Medicines Agency (EMA) and by Health Canada, which maintained the marketing authorizations for Ixchiq, with updated product information. To date, approximately 187,000 doses of Ixchiq have been administered globally.

While the Company disagrees with CHM’s and MHRA’s conclusion, Valneva has decided not to appeal the decision, given its immaterial financial and commercial impact, and in line with the Company’s strategic focus on expanding access to Ixchiq in endemic territories, where the risk of chikungunya virus infection is highest.