Valneva’s single-shot chikungunya vaccine – IXCHIQ®/ VLA1553

  • IXCHIQ® was the world’s first licensed chikungunya vaccine available to addresses this significant unmet medical need.
  • It is approved in Europe[1] and Canada[2] for the prevention of disease caused by the Chikungunya virus in individuals 12 years of age and older.[3] In the United Kingdom[4] and Brazil, it is approved in individuals between ages 18-59. In the US, the license was temporarily suspended in August 2025, as the FDA reviewed four cases of severe adverse events, mostly in elderly individuals with multiple underlying health conditions.[5] In January 2026, Valneva announced that the Company decided to voluntarily withdraw the biologics license application (BLA) and Investigational New Drug (IND) application for IXCHIQ®, in the United States.[6]
  • To make  IXCHIQ® more accessible to Low- and Middle-Income Countries (LMIC),  Valneva entered a partnership with the Coalition for Epidemic Preparedness (CEPI) in 2019, with support from the European Union (EU) Horizon program, and received a $24.6 million grant. This partnership was extended in 2024[7] through a new $41.3 million grant.
  • In January 2026, Valneva and Instituto Butantan announced the initiation of a Pilot Vaccination Strategy (PVS) in Brazil using IXCHIQ®.
    The pilot vaccination program will serve as the basis for post-marketing commitment studies evaluating the effectiveness and safety of IXCHIQ® in a real-world setting and generating real-world evidence in a large population.
  • Additionally, Valneva is continuing to generate additional clinical data to support label extensions and further establish IXCHIQ® as a differentiated brand. The company notably reported positive four-year Phase 3 persistence data demonstrating positive antibody persistence in 95% of study participants after a single dose, positive twelve-month Phase 3 data in adolescents and the world’s first positive Phase 2 pediatric data for a chikungunya vaccine.

 

Valneva’s press releases about VLA1553

Scientific publications about Chikungunya and VLA1553