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UK MHRA revokes IXCHIQ marketing authorization; Valneva says impact immaterial
VALNValneva SE
The UK Medicines and Healthcare products Regulatory Agency (MHRA) revoked the marketing authorization for Valneva's travel vaccine, IXCHIQ, following a benefit-risk assessment by the Commission on Human Medicines. The decision was based on previous safety data without any newly identified signals. Valneva stated that due to low sales and lack of active distribution in the UK for several months, it expects no recall expenses and only minimal impact on overall revenue. The company decided not to appeal the ruling given its immaterial financial effect. IXCHIQ licenses remain valid in the EU, Canada, Brazil, and other territories where over 187,000 doses have been administered globally. Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases.