Valneva SE (NASDAQ: VALN) recently announced a strategic withdrawal of its biologics license application (BLA) as well as its Investigational New Drug (IND) application concerning its chikungunya vaccine, branded as Ixchiq, specifically in the United States. This step reflects a response to regulatory actions and emerging safety signals connected with the vaccine's deployment in the U.S. market.
In August 2025, the U.S. Food and Drug Administration (FDA) issued a suspension of the Ixchiq vaccine license. This move was prompted by the identification of four newly reported serious adverse events (SAEs) demonstrating symptoms characteristic of chikungunya-like illness. The suspension necessitated that Valneva await clarification on the FDA’s formal response before proceeding further with the license application process.
However, subsequent developments revealed that the FDA has placed the Ixchiq IND on clinical hold. This action was taken following the emergence of a newly reported foreign SAE under investigation. Notably, there are no active clinical trials administering Ixchiq to participants in the U.S. at present, as a result of these regulatory holds.
Valneva has expressed intentions to pursue its planned post-marketing clinical investigations, contingent upon fruitful engagement and agreement with the appropriate regulatory bodies. The particular SAE prompting the latest clinical hold involved a younger adult outside of the United States, who had received three vaccines simultaneously, including Ixchiq. The company has acknowledged that, based on currently available data submitted to the U.S. Vaccine Adverse Event Reporting System (VAERS) and pharmacovigilance networks consistent with the product’s licensure, there exists a plausible link between the vaccination and the adverse event; however, definitive causal relationships have not been established.
Valneva is actively engaged in efforts to obtain additional clinical information to better characterize the SAE case, reflecting a methodical approach to safety assessment and regulatory compliance. Parallel to the U.S. developments, the company maintains ongoing proactive dialogue with health authorities in other territories where Ixchiq holds licensure, notably including Europe, Canada, the United Kingdom, and Brazil.
Ixchiq currently targets travelers to regions where the chikungunya virus is endemic, such as areas of Asia, Africa, and the Americas characterized by tropical and subtropical climates. Additionally, vaccination is designated for individuals assessed to be at heightened risk in line with approved indications and vaccination guidelines. Valneva underscores that, despite the recent regulatory challenges in the United States, the benefit-risk profile of Ixchiq remains favorable for residents in endemic zones and during outbreak scenarios. The vaccine’s positioning as a durable, single-dose option could prove uniquely advantageous in these contexts.
In other company developments, Valneva has shared final Phase 2 safety and immunogenicity data for its Lyme disease vaccine candidate, VLA15, from study VLA15-221. This data was released in November 2025 and represents progress towards subsequent clinical milestones. The company’s partner for VLA15, Pfizer Inc. (NYSE: PFE), has indicated plans to seek regulatory submissions, including a Biologics License Application to the FDA and a Marketing Authorization Application to the European Medicines Agency, anticipated in 2026, conditional on favorable Phase 3 results.
The market responded to the Ixchiq-related news with shares of Valneva declining by approximately 4.37%, trading at $9.63 as of the last check following the announcement.