Valneva lifts EMA’s temporary restriction on use of chikungunya vaccine IXCHIQ in elderly
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Valneva lifts EMA’s temporary restriction on use of chikungunya vaccine IXCHIQ in elderly

The agency concluded that for people of all ages, IXCHI should be administered when there is a significant risk of chikungunya infection

  • By IPP Bureau | July 15, 2025

Valneva, a specialty vaccine company, announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and older with IXCHIQ, Valneva’s single-dose chikungunya vaccine. The decision follows a thorough review by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).

The committee began its review in May after reports of serious side effects, mainly in elderly people with multiple underlying medical conditions. In a statement published today on its website¹, the EMA noted that the vaccine is already contraindicated for people with weakened immune systems. The agency concluded that for people of all ages, IXCHI should be administered when there is a significant risk of chikungunya infection and after carefully weighing the benefits and risks.

The EMA also noted that while most of the serious side effects occurred in older adults, IXCHIQ remains effective in triggering the production of antibodies against chikungunya. This could be particularly important for older people, who face a higher risk of severe chikungunya disease.

IXCHIQ was authorized in the European Union in June 2024, and in March 2025, the European Commission granted a label extension to include adolescents aged 12 years and older.

 

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