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Valneva receives first marketing authorization for Ixchiq vaccine in a chikungunya endemic country

Valneva SE announced that the Brazilian Health Regulatory Agency (ANVISA) approved Ixchiq vacccine 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 ISA) has granted marketing authorization to its single-dose vaccine Ixchiq for chikungunya 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).
This important approval primarily enables initiation of large-scale clinical trials of Ixchiq in Brazil, including the committed Phase IV clinical trials supporting Ixchiq’s approval by the FDA and the European Commission to generate additional data on vaccine effectiveness. CEPI is providing funding support to these trials.
Dr. Juan Carlos Jaramillo, 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.”