Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) and French biotech firm 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 up to $41.3 million of additional funding over the next five years, with support from the European Union’s (EU) Horizon Europe programme.

The project will help generate additional data to potentially support extended IXCHIQ labels in chikungunya- endemic countries and vulnerable populations at risk of being infected with this debilitating mosquito-borne disease.

Several thousand participants are set to take part in the planned trials, due to start in 2025. The research will include assessment of the vaccine in children aged 1-11 and pregnant women in countries that may be affected by a chikungunya outbreak. Some trials are planned to be conducted in Brazil, which is currently facing a significant chikungunya outbreak with over 340,000 cases reported so far this year.

The expanded partnership strengthens an earlier agreement which awarded Valneva $24.6 million in CEPI-EU funding to develop, manufacture, and market 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 an adolescent clinical trial in Brazil to support licensure of the vaccine in this country, which would be the first potential approval for use in endemic populations, as well as label extension in this age group in the US and other territories.

Review of the marketing authorisation application for IXCHIQ by the Brazilian Health Regulatory Agency (ANVISA) is ongoing with potential approval in 2024.

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