Investing.com -- Valneva (EPA: VLS ) SE ADR (NASDAQ: VALN ) stock closed up 12.1% following the announcement that the Brazilian Health Regulatory Agency (ANVISA) has granted the first marketing authorization for its chikungunya vaccine, IXCHIQ®, in a country where the disease is endemic. The approval, announced on April 14, 2025, is a significant milestone for the specialty vaccine company, as it marks the world’s first approval of a chikungunya vaccine in an endemic country.

The authorization in Brazil is part of Valneva’s strategy to address the unmet medical needs in low-and-middle-income countries (LMICs) and is supported by the Coalition for Epidemic Preparedness Innovations (CEPI), with co-funding from the European Union and Instituto Butantan. The approval enables the initiation of large-scale clinical trials in Brazil, including Phase 4 trials to generate additional data on the vaccine’s effectiveness.

IXCHIQ® is also approved in the EU, the U.S., Canada, and the U.K. for the prevention of disease caused by the chikungunya virus, with label extension applications submitted for adolescents in these regions. ANVISA is currently reviewing another chikungunya vaccine candidate, VLA1555, which is anticipated to be approved in mid-2025 and will be locally manufactured and distributed by Instituto Butantan.

Valneva’s Chief Medical Officer, Juan Carlos Jaramillo, M.D., expressed gratitude towards partners CEPI and Instituto Butantan for their support in addressing the urgent medical need posed by chikungunya, especially in LMICs. Dr. Esper Kallás, Director of Instituto Butantan, highlighted the vaccine’s importance for Brazil, which suffers from over 150,000 chikungunya cases annually.

Dr. Richard Hatchett, CEO of CEPI, emphasized the collaborative effort leading to the vaccine’s approval, which represents a significant step in the fight against chikungunya and expands access to populations in need.

The Americas reported nearly 300,000 chikungunya cases and 300 deaths from January to July 2023, with Brazil having the highest number of cases. Valneva’s partnership with the Serum Institute of India, announced in December 2024, will enable vaccine supply in Asia. The company is also conducting trials to potentially extend the vaccine’s label to children and evaluate its use in pregnant women in chikungunya-affected countries.

Valneva’s stock movement reflects investor optimism following the Brazilian regulatory approval, which could pave the way for further access to the chikungunya vaccine in other endemic regions.

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