Valneva Reports Positive Final Data for IXCHIQ Vaccine
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."
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Valneva Withdraws Ixchiq Vaccine Applications Amid FDA Hold
- Application Withdrawal: Valneva SE has voluntarily withdrawn its Biologics License Application (BLA) and Investigational New Drug (IND) application for the Ixchiq vaccine in the U.S. following the FDA's suspension of the license in August 2025 due to four reports of serious adverse events (SAEs) resembling chikungunya illness.
- Clinical Hold: The FDA has placed the IND for Ixchiq on clinical hold pending an investigation into a newly reported foreign SAE, resulting in no active clinical studies vaccinating participants, which significantly impacts the company's vaccine rollout strategy.
- Safety Assessment: Valneva is actively seeking additional information to further characterize the case related to Ixchiq vaccination, as the case may be plausibly linked to the vaccine, although causality has not been established, potentially affecting public confidence and market acceptance of the vaccine.
- Future Plans: Despite these challenges, Valneva intends to continue discussions with health authorities in all territories where Ixchiq is licensed and plans to advance post-marketing clinical activities, while also looking forward to submitting a Biologics License Application for the Lyme disease vaccine candidate VLA15 in collaboration with Pfizer in 2026.

Valneva SE Withdraws Chikungunya Vaccine Applications, Shares Drop 7.7%
- Vaccine Withdrawal: Valneva SE has withdrawn its BLA and IND applications for the IXCHIQ Chikungunya vaccine due to an FDA suspension and review of new serious adverse events, leading to a 7.7% drop in pre-market trading to $9.29, indicating market concerns over its product prospects.
- Market Decline: U.S. stock futures are broadly lower, with Dow futures falling around 700 points, reflecting investor caution regarding economic outlook, which may impact overall market sentiment and exacerbate volatility in other stocks.
- Other Stock Movements: Shares of Rezolve AI PLC and POET Technologies Inc fell 15% and 11.2% respectively in pre-market trading, indicating widespread investor apprehension towards tech stocks, potentially prompting a reassessment of risk appetite.
- Tesla Update: Tesla's stock fell 2.7% to $425.75 in pre-market trading, despite CEO Elon Musk confirming that vehicles equipped with the AI4 chip will achieve unsupervised autonomous driving, suggesting insufficient market confidence in the electric vehicle sector.






