The Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to Valneva SE’s single-dose vaccine Ixchiq for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.

Chikungunya virus is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes, which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash.

Joint pain is often debilitating and can persist for weeks to years.

The ANVISA decision marks the world’s first approval of a chikungunya vaccine in an endemic country.

Also Read: Valneva Vaccine Shows Sustained Immune Response In Adolescents One Year After Single Shot

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.

In addition to Brazil, Ixchiq is approved for preventing disease caused by the chikungunya virus in people aged 12 years and older in the E.U. and those aged 18 years and older in the U.S., Canada and the U.K.

Label extension applications to adolescents were submitted in the U.S., Canada and the U.K.

The approval primarily enables the initiation of large-scale clinical trials of Ixchiq in Brazil, including the committed phase four 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 and support for these trials.

ANVISA continues to review VLA1555, the chikungunya vaccine candidate which, if approved, will be locally manufactured and distributed by Instituto Butantan under 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.

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 one million total between January 2019 and July 2024.

Additionally, as part of the CEPI and EU support, Valneva is conducting a Phase 2 trial in children aged one to 11 years in the Dominican Republic and Honduras, for which positive results were reported in January 2025.

The trial is intended to support a pivotal phase three study in children, which the company expects to initiate in the fourth quarter of 2025 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.

VALN Price Action: VALN stock is up 10.02% at $6.92 at publication Monday.

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