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UK revokes Valneva's IXCHIQ marketing authorization after benefit-risk review

October 7, 2026 4:00 PM

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has revoked the marketing authorization for Valneva SE's (Nasdaq: VALN; Euronext Paris: VLA) chikungunya vaccine IXCHIQ, following a benefit-risk assessment by the Commission on Human Medicines (CHM).

According to a statement from Valneva, the decision was based on a review of existing safety data and was not associated with any newly identified safety signal. The revocation applies only to the UK and does not affect IXCHIQ's product licenses in the European Union, Canada, Brazil, or other markets where the vaccine is currently sold.

IXCHIQ was launched in the UK in mid-2025 but saw low sales among travelers. Valneva said it had not actively distributed the vaccine in the UK for several months prior to the revocation, and no product remains on the UK market. The company said it expects no product recall expenses and only minimal impact on overall sales revenue.

Valneva said it disagrees with the MHRA's conclusion but has decided not to appeal the decision, citing its limited financial and commercial impact. The European Medicines Agency and Health Canada recently completed similar safety reviews and maintained their respective marketing authorizations for IXCHIQ, with updated product information.

Valneva noted that more than 61,000 people aged 18 to 59 have been vaccinated under an ongoing pilot vaccination strategy in Brazil, with no new safety concerns identified. Approximately 187,000 doses of IXCHIQ have been administered globally to date.

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