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.
[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