ANVISA grants marketing authorization for Valneva’s Ixchiq in Brazil

BRAZIL—French drugmaker Valneva has achieved a significant milestone: the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization for its single-dose chikungunya vaccine, Ixchiq, for adults aged 18 and older.

This marks the first approval of a chikungunya vaccine in a country where the disease is endemic, underscoring the importance of this development for public health in Brazil and similar regions.

This authorization follows earlier approvals of Ixchiq by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), the European Commission, and Health Canada, where the vaccine is available for adults 18 years and above.

 The vaccine is also approved for adolescents aged 12 and older in the European Union, and ongoing applications are being made to extend this label to adolescents in the US, Canada, and the UK.

Chikungunya is a viral disease transmitted by Aedes mosquitoes, causing symptoms such as fever, severe joint pain, headaches, muscle pain, and rash.

The Americas have experienced a high burden of chikungunya, with nearly 300,000 cases and 300 deaths reported between January and July 2023 alone, and Brazil accounting for over 1 million cases since 2019.

 The introduction of Ixchiq in Brazil is expected to address this significant unmet medical need.

The Coalition for Epidemic Preparedness Innovations (CEPI) supports the vaccine’s development and distribution, with joint funding from the European Union and Brazil’s Instituto Butantan.

This partnership aims to ensure broader access to the vaccine in low- and middle-income countries (LMICs), particularly in Latin America.

Instituto Butantan will also manufacture and distribute another chikungunya vaccine candidate, VLA1555, pending approval expected by mid-2025. This local production is intended to provide affordable vaccines for the region.

The Brazilian authorization enables the start of large-scale clinical trials, including CEPI-funded Phase IV studies to gather additional data supporting regulatory approvals in the US and Europe.

Valneva and Instituto Butantan are collaborating closely to expedite vaccine access in Brazil and neighboring countries.

Further expanding its reach, Valneva announced a collaboration with the Serum Institute of India in December 2024 to facilitate vaccine supply in Asia, broadening the vaccine’s global impact.

 Additionally, Valneva is conducting a Phase II trial of Ixchiq in pediatric patients aged one to 11 in Honduras and the Dominican Republic, with positive results reported in January 2025.

Plans are also underway to evaluate the vaccine’s safety and efficacy in pregnant women in chikungunya-affected countries such as Brazil.

CEPI CEO Dr. Richard Hatchett highlighted the significance of ANVISA’s approval, stating it offers new hope in combating the debilitating disease and helps protect tens of thousands of people in Brazil annually.

 He emphasized the power of collaboration and innovation in addressing this public health challenge.

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