The company was recently notified of a new FDA decision to now suspend the IND (investigational new drug application) pending further information regarding a newly reported serious adverse event abroad.

The event in question involved a young adult who had received three different vaccines simultaneously, including Ixchiq. The company is actively seeking additional data to better analyze this event.

Valneva continues to believe that the benefit-risk profile of Ixchiq remains favorable for populations living in endemic or epidemic areas, where it could stand out as a single-dose vaccine offering lasting protection.

No clinical study involving active administration of Ixchiq is currently underway. Valneva plans to initiate the planned post-marketing clinical activities for the vaccine, subject to further discussions with the relevant regulatory authorities.