(Reuters) -The European Union’s health regulator has lifted the temporary restriction on the use of French drugmaker Valneva’s chikungunya vaccine, Ixchiq, in adults aged 65 and above, following a safety review.
The European Medicines Agency’s (EMA) safety committee had temporarily suspended use of the vaccine, branded Ixchiq, among the elderly in May as a precautionary measure.
Chikungunya is a mosquito-borne disease that causes sudden fever and joint pain, transmitted by bites from infected Aedes mosquitoes.
Ixchiq, the first preventive vaccine for chikungunya approved in both Europe and the United States, uses a weakened form of the virus to stimulate an immune response.
Since its approval in the EU in 2024, more than 36,000 doses have been administered globally.
The EMA panel found that while serious adverse events, including two deaths, were reported in people aged 62 to 89—often those with underlying health conditions—the vaccine remains effective in generating immunity.
Older adults are at higher risk of severe chikungunya infection, making vaccination important in certain circumstances.
As a result, the panel recommends the vaccine should now be reserved for situations where there is a significant risk of chikungunya infection, after careful benefit-risk assessment.
The agency warned against administering Ixchiq to patients with compromised immune systems.
Valneva did not immediately respond to Reuters’ request for a comment.
The agency will update product information to reflect the new recommendations.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Tasim Zahid)
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