RegulatoryOct 8, 2026, 08:01 AM
Valneva's IXCHIQ® UK Marketing Authorization Revoked by MHRA
AI Summary
Valneva SE announced that the UK's MHRA has revoked the marketing authorization for its chikungunya vaccine, IXCHIQ®, based on a review of previous safety data without any new safety signals. This decision does not affect the product's status in the EU, Canada, Brazil, or other markets. Valneva expects minimal financial impact due to low sales in the UK and will not appeal the decision. The company maintains its belief in the vaccine's favorable benefit-risk profile, supported by global administration of approximately 187,000 doses and ongoing positive safety reviews in other regions.
Key Highlights
- UK marketing authorization for Valneva's IXCHIQ® revoked by MHRA following further benefit-risk assessment.
- Decision based on review of previous safety data; no new safety signal identified.
- Marketing authorizations for IXCHIQ® remain valid in EU, Canada, Brazil, and other territories.
- Valneva expects minimal impact on overall sales revenue due to low UK sales and no product remaining on market.
- Valneva disagrees with the decision but will not appeal due to immaterial financial and commercial impact.
- Approximately 187,000 doses of IXCHIQ® administered globally to date with no new safety concerns identified in ongoing pilot vaccination strategy in Brazil.
Price Impact
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