July 11 (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.