CEPI Grants $41.3 Million to Valneva to Boost Access to Chikungunya Vaccine

Valneva SE, in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), is set to receive up to $41.3 million to increase access to its chikungunya vaccine, IXCHIQ®, in low- and middle-income countries (LMICs). This funding, supported by the European Union’s Horizon Europe programme, will assist in conducting clinical trials in children and pregnant women, expanding the vaccine's reach and utility.

The additional funding aims to gather more data to potentially extend the vaccine's label in regions endemic to chikungunya, targeting populations at high risk of the disease. These trials are anticipated to commence in 2025, involving thousands of participants. Key focus groups include children aged 1-11 and pregnant women, with some trials planned for Brazil, a country currently experiencing a significant chikungunya outbreak with over 340,000 cases reported this year.

This expansion builds on a prior agreement where Valneva received $24.6 million in CEPI-EU funding to develop and market the single-dose vaccine in certain LMICs. Initially, Valneva collaborated with Brazil’s Instituto Butantan (IB) in 2021, conducting adolescent clinical trials to support the vaccine’s licensure in Brazil, which would mark its first approval for use in endemic regions. The Brazilian Health Regulatory Agency (ANVISA) is currently reviewing the marketing authorization application for IXCHIQ®, with potential approval expected in 2024. Once approved, IB plans to produce and distribute the vaccine at an affordable price across Latin America and selected LMICs.

The new funding will also facilitate the transfer of vaccine production technology to another manufacturer, enhancing access to IXCHIQ® in Asian LMICs vulnerable to chikungunya outbreaks. This technology transfer is crucial for speeding up and broadening the vaccine's availability.

Dr. Richard Hatchett, CEO of CEPI, highlighted the importance of providing an affordable chikungunya vaccine to regions heavily burdened by the disease. He emphasized that the clinical studies and technology transfer to additional manufacturers will expedite the vaccine's availability in endemic countries, contributing to future vaccine rollout strategies and mitigating the impact of chikungunya outbreaks.

Thomas Lingelbach, CEO of Valneva, expressed enthusiasm for the strengthened partnership with CEPI. He stressed the significant unmet medical need for chikungunya prevention and noted the unique advantage of Valneva’s single-dose vaccine in protecting populations in endemic areas and travelers. Lingelbach also pointed out the growing concern of climate change, which is expanding the habitats of mosquitoes that transmit the virus, thereby increasing the risk of infection.

Esper Kallás, Director of Instituto Butantan, remarked on the rising global concern of arboviruses due to climate change, which facilitates the spread of mosquitoes to new environments. He reiterated Butantan's commitment to co-develop the chikungunya vaccine, which aligns with their mission to tackle public health issues both locally and globally.

The European Commission’s representatives, Laurent Muschel and Irene Norstedt, underscored the EU's commitment to ensuring access to medical countermeasures for vulnerable populations. They noted the importance of the Horizon Europe programme in supporting research and clinical studies to enhance preparedness against vector-borne diseases, which are likely to spread to non-endemic regions due to climate change.

IXCHIQ® has already received approvals in the U.S. in November 2023, and in Canada and Europe in June 2024. Regulatory reviews are ongoing in Brazil and the United Kingdom. Pending approvals, upcoming trials will assess the vaccine's effectiveness in Brazil, its efficacy in outbreak settings in LMICs, safety and immunogenicity in pregnant women, and optimal doses for children aged 1-11 in various regions. These efforts aim to address the global health challenge posed by chikungunya, a mosquito-borne disease causing severe joint pain and other debilitating symptoms. The disease, which re-emerged in 2004, has now spread to over 110 countries and poses a significant medical and economic burden exacerbated by climate change.

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