Valneva Secures First IXCHIQ Approval in Chikungunya-Endemic Country
Valneva SE, a specialty vaccine company announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to its single-dose vaccine IXCHIQ for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The ANVISA decision marks the world’s first approval of a chikungunya vaccine in an endemic country. Part of Valneva’s endemic country strategy, this endeavor is supported by the Coalition for Epidemic Preparedness Innovations (CEPI), with co-funding from the European Union (EU), and Instituto Butantan to support broader access to a chikungunya vaccine in low-and-middle-income countries (LMICs).
IXCHIQ® is the world’s first licensed chikungunya vaccine available to address this significant unmet medical need. In addition to Brazil, IXCHIQ® is approved for the prevention of disease caused by the chikungunya virus in people aged 12 years and older in the EU, and in people aged 18 years and older in the United States (U.S.), Canada and the United Kingdom (U.K.). Label extension applications to adolescents were submitted in the U.S., Canada and the U.K.
This important approval primarily enables initiation of large-scale clinical trials of IXCHIQ in Brazil, including the committed Phase 4 clinical trials supporting IXCHIQ’s approval by the U.S. Food and Drug Administration (FDA) and the European Commission to generate additional data on vaccine effectiveness. CEPI is providing funding support to these trials.
ANVISA continues to review VLA1555, the chikungunya vaccine candidate which, if approved, will be locally manufactured and distributed by Instituto Butantan pursuant to its collaboration with Valneva. Potential approval is anticipated in mid-2025. Instituto Butantan is committed to providing a locally manufactured vaccine at an affordable price in Latin America and selected LMICs.
Valneva and Instituto Butantan are working together to ensure fast access to its chikungunya vaccines for the Brazilian market and other countries in the region as quickly as possible. The Americas saw nearly 300,000 chikungunya cases and 300 deaths attributed to the virus between January and July 2023, totaling more than 720,000 cases since 2020. Brazil has reported the highest number of cases, with over 1 million total between January 2019 and July 2024.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This approval marks a crucial milestone toward making our chikungunya vaccine available to LMICs where the disease is endemic. The ongoing outbreak in Brazil underscores the fact that containing chikungunya is an international public health priority. Our vaccine is particularly well suited for LMICs, where vaccine access is often limited, due to its ability to induce a robust, long-lasting antibody response in both younger and older adults with a single vaccination. We would like to thank our partners CEPI and Instituto Butantan for helping us address this urgent medical need by accelerating further access to our highly differentiated vaccine.”
Dr. Esper Kallás, Director of Instituto Butantan added, “The approval of the chikungunya vaccine is a great victory for Brazil, where over 150,000 people suffer from the disease every year. It is an honor for Butantan to be able to contribute to ensuring that this vaccine reaches the population that needs it the most.”
Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), commented, “As we confront the ongoing challenges posed by chikungunya, today marks a significant step forward in our collective efforts to expand access to an important vaccine to not only benefit the travelers’ market but also populations in need in outbreak-affected countries, like Brazil. ANVISA’s marketing authorization of the vaccine offers new hope in the fight against the debilitating disease and allows us to make headway in our goal to protect the tens of thousands in the country who suffer from chikungunya each year. Brazil’s approval is testament to the power of collaboration, innovation and determination and should help set the world up for additional approvals in other endemic regions in the near future.”
Supported by CEPI and the EU’s Horizon program, Valneva remains focused on expanding the vaccine’s access in LMICs. In December 2024, Valneva announced a new partnership with the Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses, enabling supply of the vaccine in Asia.
Additionally, as part of the CEPI and EU support, Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, for which it reported positive results in January 2025. The trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the fourth quarter of 2025, with the objective to extend the product label to this age group. Valneva is also expected to evaluate the vaccine in pregnant women in countries affected by chikungunya outbreaks, like Brazil .
