The Coalition for Epidemic Preparedness Innovations (CEPI) has expanded its partnership with Valneva, committing up to $41.3m to support post-marketing trials of IXCHIQ, a chikungunya vaccine.
The expansion will also support broader access to the vaccine and potential extensions of the label in children, adolescents, as well as pregnant women.
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This initiative is aimed at making the vaccine available in low- and middle-income countries (LMICs).
The funding, part of the European Union’s Horizon Europe programme, will be distributed over the next five years.
It is intended to generate data that could support extended vaccine labels for use in children, adolescents, and pregnant women in chikungunya-endemic regions.
Trials involving several thousand participants are set to begin next year.
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By GlobalDataThese studies will assess the vaccine’s efficacy in children aged one to 11 years and pregnant women, primarily in nations at risk of chikungunya outbreaks.
Brazil, currently experiencing an outbreak with over 340,000 cases so far this year, is among the planned locations for these trials.
This collaboration builds on a previous agreement which granted Valneva $24.6m from CEPI-EU to develop and market the vaccine in select LMICs.
Under this agreement, Valneva and Brazil’s Instituto Butantan conducted a trial in Brazilian adolescents to support the vaccine’s licensure.
The Brazilian Health Regulatory Agency (ANVISA) is currently reviewing the marketing authorisation application for IXCHIQ, with potential approval expected this year.
CEPI-EU funding will also facilitate the technology transfer to an additional vaccine manufacturer, aiming to accelerate and widen IXCHIQ access in Asian LMICs.
Valneva CEO Thomas Lingelbach said: “We are extremely pleased to strengthen our partnership with CEPI. Chikungunya infection is a major unmet medical need, and we believe that our single-dose vaccine is uniquely positioned to help protect people living in areas where chikungunya occurs and for travellers to these regions.
“With climate change, more areas across the world are becoming habitable for the mosquito vectors that transmit the virus, thereby increasing the size of the human population at risk of infection.”
In December last year, the company reported positive antibody persistence data from its Study VLA1553-303 of a single dose of chikungunya vaccine, IXCHIQ.
