Valneva SE announced that the U.S. Food and Drug Administration (FDA) has lifted its previously recommended pause on the use of the company’s Chikungunya vaccine, IXCHIQ, in individuals aged 60 and older. The agency also approved updates to the Prescribing Information (PI) to include new safety information.
IXCHIQ remains approved in the U.S. for the prevention of Chikungunya virus (CHIKV) in adults aged 18 and older who are at high risk of exposure to the virus. The FDA’s decision comes shortly after the European Medicines Agency (EMA) recommended lifting similar temporary restrictions in elderly individuals following a comprehensive safety review conducted by its Pharmacovigilance Risk Assessment Committee (PRAC).
The updated U.S. prescribing information now includes details of Serious Adverse Events (SAEs), primarily reported in elderly individuals with multiple underlying health conditions during a mass vaccination campaign in La Réunion, which followed a significant chikungunya outbreak.
The FDA emphasized that while IXCHIQ is an important preventive tool, the risk of CHIKV exposure is low for most U.S. travelers, and vaccination should be considered only when there is a significant risk of infection. The vaccine continues to be contraindicated for people with weakened immune systems due to illness or immunosuppressive treatments, as reflected in product labels across the U.S., Europe, and other regions.
In addition, the Warnings and Precautions section of the PI has been expanded to better reflect the observed SAE profile, especially in patients over 65 years of age with one or more chronic medical conditions.
Valneva noted that the FDA is also continuing its ongoing review of potential label extensions, including the possible use of IXCHIQ in adolescents and inclusion of longer-term efficacy data.
The company remains committed to working with global regulators to ensure safe access to the vaccine for populations at risk of chikungunya infection.