Valneva has received marketing authorisation from the Brazilian Health Regulatory Agency (ANVISA) for its single-dose chikungunya vaccine, Ixchiq, for individuals aged 18 years and above.
This is the first approval of a chikungunya vaccine in a country where the condition is endemic.
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Chikungunya is a viral disease spread through the bites of Aedes mosquitoes, which causes fever, severe joint pain, headaches, muscle pain and rash.
The initiative is backed by the Coalition for Epidemic Preparedness Innovations (CEPI), joint funding from the European Union and Brazil’s Instituto Butantan to ensure wider access in low and middle-income countries (LMICs).
Ixchiq is also approved in the European Union for preventing the condition in those aged 12 years and above, and in individuals aged 18 years and over in the UK, Canada and the US.
Valneva has filed label extension applications for adolescents in these regions.
The authorisation in Brazil paves the way for the commencement of clinical studies, including CEPI-funded Phase IV studies to support US Food and Drug Administration (FDA) and European Commission approvals of the vaccine.
The Brazilian regulator is also reviewing another chikungunya vaccine candidate, VLA1555. Once approved, Instituto Butantan will manufacture and distribute it locally along with the company. Approval is expected by mid-2025.
The institute aims to offer an affordable vaccine for the Latin American region and certain LMICs.
Instituto Butantan and the company are collaborating to expedite access to chikungunya vaccines in Brazil and the region.
With CEPI and the EU’s Horizon programme support, the company is also broadening vaccine access in LMICs.
CEPI CEO Dr Richard Hatchett stated: “ANVISA’s marketing authorisation 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.”
A new collaboration with the Serum Institute of India, announced in December 2024, will facilitate the vaccine supply in Asia.
The company is carrying out a Phase II trial in paediatric patients aged one to 11 years in Honduras and the Dominican Republic. Positive outcomes were announced in January 2025.
The company also plans to assess the vaccine in pregnant women in chikungunya-affected nations such as Brazil.
In August 2024, the company and LimmaTech Biologics entered a strategic collaboration to advance the development of the Shigella4V vaccine.
