Valneva said Wednesday that the UK Medicines and Healthcare products Regulatory Agency has revoked the marketing authorization for IXCHIQ, its single-dose chikungunya vaccine, following a further benefit-risk assessment by the Commission on Human Medicines. The review examined existing safety data and identified no new safety signal, but the regulators concluded the authorization could no longer stand for travelers.
The UK action follows a tightening sequence. Britain approved IXCHIQ in February 2025, restricted its use for adults 60 and older and people with hypertension, cardiovascular disease, diabetes or chronic kidney disease in February 2026 after reports of very rare fatal reactions and other serious adverse events globally, and has now pulled the authorization outright. The vaccine’s retreat began when the FDA suspended its U.S. license in August 2025 over serious adverse events, after which Valneva withdrew its U.S. applications.
Valneva said it disagrees with the conclusion but will not appeal, calling the financial and commercial impact immaterial. The vaccine has not been actively distributed in the UK for several months because of low demand among travelers, so the company expects no recall expense and minimal revenue impact. IXCHIQ remains authorized in the EU, Canada, Brazil and other markets, where the EMA and Health Canada recently maintained authorizations with updated product information.
The company pointed to its Brazil pilot vaccination strategy, where more than 61,000 people have been vaccinated with no new safety concerns, and to roughly 187,000 doses administered worldwide. IXCHIQ contributed 8.4 million euros in 2025 product sales. For Valneva, whose most advanced pipeline asset is a late-stage Lyme disease vaccine partnered with Pfizer, the UK exit is the second license loss in a year and keeps the regulatory cloud over the program even as endemic-market sales continue elsewhere.