EMA Lifts Temporary Restriction on Valneva's Chikungunya Vaccine IXCHIQ® Use in Elderly

VALN
October 08, 2025

Valneva SE announced on July 11, 2025, that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above with its single-dose chikungunya vaccine, IXCHIQ®. This decision follows a thorough review by EMA's safety committee (PRAC), which had initiated its review in early May due to reports of serious side effects.

The EMA concluded that for people of all ages, IXCHIQ® should be administered when there is a significant risk of chikungunya infection and after careful consideration of benefits and risks. The agency noted that while most serious side effects occurred in older people, IXCHIQ® is effective in triggering antibody production, which can be particularly beneficial for older individuals at increased risk of severe chikungunya disease.

This lifting of restrictions is a positive development for IXCHIQ®, which was authorized in the European Union in June 2024 and received a label extension for adolescents aged 12 and older in March 2025. It restores broader access to the vaccine in Europe, supporting its commercial potential.

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