VALN News & Events

Valneva SE announced that the company has decided to voluntarily withdraw the biologics license application, BLA, and Investigational New Drug, IND, application for its chikungunya vaccine, Ixchiq, in the United States, following suspension of the license by the U.S. Food and Drug Administration, FDA, in August 2025. The Company had been awaiting further information with respect to its formal response to the vaccine license suspension. Valneva was recently informed of the FDA's further decision to now place the Investigational New Drug, IND, on clinical hold pending an investigation of a newly reported foreign Serious Adverse Event, SAE. There are currently no clinical studies involving Ixchiq that are actively vaccinating participants, and the Company intends to move forward with its planned post-marketing clinical activities, subject to further discussions with relevant regulatory authorities.

Valneva and Serum Institute of India announced that they have mutually agreed to discontinue their license agreement for Valneva's single-shot chikungunya vaccine. "Valneva's strategic intent in regaining full rights is to assume direct control over its supply chain and commercialization for endemic high-risk countries, thereby accelerating access for regions most affected by the disease. Supporting access to the vaccine in low-and-middle-income countries falls within the framework of the funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations in July 2024 with co-funding from the European Union," the company stated.

Valneva announced "positive" final antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ, in 304 children, twelve months after vaccination. Final VLA1553-221 results aligned with the initial data and six-month outcomes that the company previously reported for this trial in January 2025 and June 2025, respectively, the company stated. The strong immune response was confirmed in CHIKV-naive children with a 94.7% seroresponse rate at Day 360. The vaccine was well tolerated in children aged one to eleven years regardless of the dose or previous CHIKV infection. No safety concerns were identified. Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, "The twelve months persistence and safety data in children are consistent with the robust antibody response and favorable safety profile previously observed in adolescents following a single vaccination. As safety is of the utmost importance, particularly when advancing into a Phase 3 pediatric study, we have decided, in alignment with the regulatory authorities, to continue gathering additional real-world experience in the adolescent population before initiating our planned Phase 3 study in children. We remain convinced, considering the significant risk chikungunya poses to individuals living in or traveling to endemic areas, that it is crucial to ensure a vaccine capable of potentially offering long-term protection from a single shot is accessible to people of all ages. This is especially important in Low- and Middle-Income countries where access to vaccines is often limited."