The Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) and French biotechnology company Valneva SE have expanded their partnership to support broader access to the world’s first chikungunya vaccine, IXCHIQ, in low- and middle-income countries (LMICs), as well as post-marketing trials and potential label extensions in children, adolescents and pregnant women.

CEPI will provide Valneva with up to $41.3 million in additional funding over the next five years, with support from the European Union (EU) Horizon Europe programme.

The project will help generate additional data to support expanded IXCHIQ labeling in countries where chikungunya is endemic and in vulnerable populations at risk of infection with this debilitating mosquito-borne disease.

Several thousand participants will be enrolled in the planned trials, which will begin in 2025. The study will evaluate the vaccine in children aged 1 to 11 years and pregnant women in countries at risk of a chikungunya outbreak. Some trials are planned to be conducted in Brazil, which is currently dealing with a significant chikungunya outbreak with more than 340,000 cases reported so far this year.

The expanded partnership reinforces an earlier agreement that awarded Valneva $24.6 million in CEPI-EU funding to develop, manufacture and commercialize its single-shot vaccine in certain LMICs affected by chikungunya. Under this initial agreement, Valneva partnered with Brazil’s Instituto Butantan (IB) in 2021 and conducted a clinical trial in adolescents in Brazil to support licensure of the vaccine in that country, which would be the first potential approval for use in endemic populations, as well as the expansion of the label in this age group in the U.S. and other territories.

The Brazilian Health Regulatory Agency (ANVISA) is currently reviewing the application for marketing authorization for IXCHIQ. Approval could occur in 2024.

The CEPI-EU funding will also support technology transfer of the vaccine product to an additional vaccine manufacturer to accelerate and expand access to IXCHIQ in LMICs in Asia vulnerable to chikungunya outbreaks.