Chikungunya – VLA1553

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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 18 and older. 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.
  • Within the framework of its CEPI agreement, Valneva announced an exclusive license agreement with the Serum Institute of India (SII)[8] at the end of 2024 to enable supply of its chikungunya vaccine in Asia. This agreement was discontinued by mutual agreement at the end of 2025.
  • 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

 

[1] Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ® – Valneva

[2] Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ® – Valneva

[3] Valneva Receives EMA’s Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ® – Valneva

[4] Valneva Receives Marketing Authorization in the UK for the World’s First Chikungunya Vaccine, IXCHIQ® – Valneva

[5] Valneva Announces FDA’s Decision to Suspend License of Chikungunya Vaccine IXCHIQ In the U.S. – Valneva

[6] Valneva Provides Update on Chikungunya Vaccine IXCHIQ

[7] CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World’s First Chikungunya Vaccine – Valneva

[8] Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India – Valneva