The Coalition for Epidemic Preparedness Innovations (CEPI) and specialised vaccine firm Valneva have expanded their collaboration to enhance the availability of the first chikungunya vaccine, Ixchiq.
Valneva and CEPI will expand access to Ixchiq in low- and middle-income countries (LMICs).
The expansion also includes conducting post-marketing trials and exploring potential label extensions for children, adolescents, and pregnant women.
Ixchiq received approval in the US in November 2023 and in Canada and Europe in June 2024.
CEPI, supported by the European Union’s Horizon Europe programme, will allocate up to $41.3m in additional funding to Valneva over the next five years.
The initiative aims to generate data that could potentially expand the labels for Ixchiq in chikungunya-endemic regions and among vulnerable populations.
The planned trials, commencing in 2025, will involve several thousand participants to assess the vaccine’s efficacy in children aged one to 11 years and pregnant women in countries at risk of chikungunya outbreaks.
These trials will be conducted at planned locations that includes Brazil, which is currently experiencing a severe chikungunya outbreak.
CEPI CEO Richard Hatchett said: “These clinical studies and tech transfer to an additional endemic-region manufacturer will accelerate endemic country access, inform future vaccine rollout strategies and alleviate the burden of future chikungunya outbreaks.”
The expanded partnership builds upon a previous agreement that initially granted Valneva $24.6m in CEPI-EU funding to develop and market Valneva’s single-shot chikungunya vaccine in certain LMICs.
Under the initial agreement, Valneva collaborated with Brazil’s Instituto Butantan (IB) in 2021 to conduct an adolescent clinical trial in Brazil.
The trial supported the vaccine’s licensure in Brazil, paving the way for use in endemic populations and label extension to include adolescents in the US and other regions.
The Brazilian Health Regulatory Agency (ANVISA) is currently reviewing the marketing authorization application for Ixchiq, with potential approval expected in 2024.
Additionally, CEPI-EU funding will facilitate the technology transfer of the vaccine drug product to another vaccine manufacturer.
The initiative aims to expedite and broaden access to Ixchiq in Asian LMICs that are vulnerable to chikungunya outbreaks.
Valneva CEO Thomas Lingelbach said: “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.”
