Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) announced on Thursday that the US Food and Drug Administration has lifted its recommended pause on the use of IXCHIQ in individuals aged 60 and older and approved updates to the vaccine's Prescribing Information.

IXCHIQ remains approved in the United States for individuals aged 18 and older at high risk of exposure to chikungunya virus.

The revised labelling follows similar action by the European Medicines Agency, which recently recommended lifting temporary restrictions for elderly use after completing a safety review.

Updates to the US Prescribing Information reflect reports of Serious Adverse Events, primarily in elderly patients with multiple chronic conditions, during a vaccination campaign in La Réunion.

The FDA emphasised that for most US travellers, the risk of exposure to chikungunya virus is low and vaccination should be based on individual risk assessment.

IXCHIQ remains contraindicated for immunocompromised individuals, and the Warnings and Precaution section now highlights SAE risks, particularly in those over 65 with existing health issues.

Regulatory reviews are ongoing regarding label expansion to include adolescents and additional long-term data.