UK revokes marketing authorization for Valneva's IXCHIQ chikungunya vaccine

The UK Medicines and Healthcare products Regulatory Agency has revoked the marketing authorization for Valneva SE's Ixchiq chikungunya vaccine following a benefit-risk assessment. The decision, based on previous safety data rather than new safety signals, does not affect licenses in the EU, Canada, or Brazil. Valneva SE will not appeal due to low UK sales and minimal financial impact, shifting its focus to endemic regions.

UK revocation of Ixchiq authorization

• ▪The UK Medicines and Healthcare products Regulatory Agency revoked the marketing authorization for Valneva SE's Ixchiq chikungunya vaccine following a benefit-risk assessment by the UK Commission on Human Medicines.
• ▪The UK Medicines and Healthcare products Regulatory Agency's revocation of the Ixchiq marketing authorization was based on a review of previous safety data and not associated with any newly identified safety signal.

Valneva's response to the UK decision

• ▪Valneva SE decided not to appeal the UK Medicines and Healthcare products Regulatory Agency's revocation decision due to its immaterial financial impact, aligning with its focus on expanding access to Ixchiq in endemic territories where chikungunya risk is highest.
• ▪No Ixchiq product remains on the UK market, and Valneva SE expects no expenses related to a product recall and only minimal impact on its overall sales revenue.
• ▪Valneva SE launched Ixchiq in the UK in mid-2025 but had not actively distributed the vaccine there for several months prior to October 2026 due to low sales among travelers.

Global safety profile of Ixchiq

• ▪Valneva SE maintains that the benefit-risk profile of Ixchiq is favorable when used in accordance with the approved indication, contraindications, warnings, and precautions.
• ▪Approximately 187,000 doses of Valneva SE's Ixchiq vaccine have been administered globally, with no new safety concerns identified in post-marketing evidence.

Ixchiq status in other markets

• ▪A pilot vaccination strategy in Brazil has vaccinated more than 61,000 people aged 18 to 59 with Ixchiq, with no new safety concerns identified.
• ▪The revocation of the UK marketing authorization does not affect the product licenses for Ixchiq in the European Union, Canada, Brazil, or other territories where the vaccine is marketed.
• ▪Recent safety reviews by the European Medicines Agency and Health Canada concluded with maintained marketing authorizations for Ixchiq, along with updated product information.

Overview of the chikungunya virus

• ▪Chikungunya is a mosquito-borne viral disease spread by Aedes mosquitoes that causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash.
• ▪Since 2004, the chikungunya virus has been identified in over 110 countries across Asia, Africa, Europe, and the Americas, with more than 3.7 million cases reported in the Americas between 2013 and 2023.

Valneva's vaccine pipeline

• ▪Valneva SE is partnering with Pfizer to develop a Lyme disease vaccine candidate, which is currently in advanced clinical development.
• ▪Valneva SE's vaccine pipeline includes the world's most clinically advanced Shigella vaccine candidate.

Debatable claims

• ▪The UK's revocation of Valneva's chikungunya vaccine is justified
• ▪The UK's regulatory divergence from other major health agencies on Ixchiq is justified
• ▪Chikungunya vaccination is unnecessary for travelers from non-endemic countries
• ▪Existing safety data is sufficient to justify revoking a vaccine's authorization