EMA lifts restriction on Valneva's chikungunya vaccine for those over 65.

The European Medicines Agency (EMA) has lifted the temporary restriction on vaccinating people over 65 with Valneva's single-dose chikungunya vaccine IXCHIQ after a thorough review. The EMA concluded that the vaccine should be given with caution, especially in people with underlying medical conditions. IXCHIQ is contraindicated for those with weakened immune systems.

The European Medicines Agency (EMA) has lifted the temporary restriction on vaccinating people over 65 with Valneva SE's single-dose chikungunya vaccine IXCHIQ®. The decision follows a thorough review by EMA's safety committee (PRAC) which concluded that the vaccine should be given with caution, especially in people with underlying medical conditions. The committee noted that IXCHIQ® is contraindicated for individuals with weakened immune systems.

The review was initiated in May following reports of serious side effects in elderly individuals with several underlying medical conditions. EMA emphasized that IXCHIQ® should be administered when there is a significant risk of chikungunya infection, and after careful consideration of the benefits and risks. The vaccine is already contraindicated for people with weakened immune systems.

IXCHIQ® was authorized in the European Union in June 2024 and received a label extension for adolescents aged 12 and above in March 2025. Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases, addressing unmet medical needs. Their pipeline includes vaccines against chikungunya, Lyme disease, Shigella, and Zika virus, among others.

The chikungunya virus is a mosquito-borne disease that causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain can be debilitating and persistent. Since 2004, chikungunya has caused large-scale outbreaks worldwide, with over 3.7 million cases reported in the Americas between 2013 and 2023 [1].

Valneva SE's stock is listed on Nasdaq (VALN) and Euronext Paris (VLA). The company's revenues from its growing commercial business help fund the advancement of its vaccine pipeline.

References:
[1] https://finance.yahoo.com/news/valneva-announces-lifting-european-medicines-153500263.html