Valneva SE announced on August 7, 2025, that the U.S. Food and Drug Administration (FDA) removed its recommended pause on the use of IXCHIQ® in individuals 60 years of age and older. The FDA also approved updates to the vaccine's Prescribing Information (PI).
IXCHIQ® remains indicated in the United States for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years of age and older at high risk of exposure. The FDA's decision follows a thorough investigation into reported Serious Adverse Events (SAEs), primarily among elderly individuals with multiple underlying health conditions during a mass vaccination campaign in La Réunion.
The updated PI now reflects the observed SAE profile, especially in people above 65 years of age with chronic medical conditions, and reminds healthcare professionals that IXCHIQ® is contraindicated in immunocompromised individuals. While the FDA noted that for most U.S. travelers the risk of exposure is low, the removal of the pause restores broader access to the vaccine in the U.S. market.
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