UK MHRA revokes Valneva chikungunya vaccine IXCHIQ marketing authorization after benefit-risk review
VALN•The UK MHRA revoked Valneva’s IXCHIQ marketing authorization after a benefit-risk reassessment, citing previously reviewed safety data and no new safety signal. The revocation does not affect licenses in other markets, and Valneva will not appeal, citing an immaterial financial impact.
1. UK authorization revoked
The UK MHRA revoked the marketing authorization for Valneva’s chikungunya vaccine IXCHIQ after a benefit-risk reassessment by the Commission on Human Medicines. The decision relied on previously reviewed safety data, with no new safety signal cited. The revocation does not affect the vaccine’s licenses in the EU, Canada, Brazil or other markets where it is sold.
2. Limited UK distribution
IXCHIQ had not been actively distributed in the UK for months because of low traveler demand, and no recall costs are expected. Valneva said it will not appeal, citing an immaterial financial impact while prioritizing expansion in endemic markets.
