UK Approves Valneva's IXCHIQ®, First Chikungunya Vaccine

On February 5, 2025, Valneva SE, a company specializing in vaccines, announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for IXCHIQ®, marking the world's first and only authorized chikungunya vaccine. This single-dose vaccine is designed for individuals aged 18 and over to prevent chikungunya virus (CHIKV) infection. Valneva's Livingston, Scotland facility is responsible for the vaccine's production.

The approval from the UK MHRA follows promising Phase 3 trial results, published in The Lancet, demonstrating that a single dose of IXCHIQ® triggers a swift and potent immune reaction. This protective response has been shown to last for at least three years across both younger and older adult populations. The UK joins the United States, Europe, and Canada in approving this vaccine for adults. Valneva aims to secure marketing authorization in Brazil by early 2025, which would be the first approval in a chikungunya-endemic nation. Additionally, Valneva has filed for label extensions with the FDA, the European Medicines Agency, and Health Canada to expand the vaccine's use to adolescents aged 12-17 and plans a similar application with MHRA.

Dr. Juan Carlos Jaramillo, Valneva’s Chief Medical Officer, emphasized the significance of this approval, highlighting the necessity for a chikungunya vaccine given the ongoing outbreak in India, a popular destination for UK travelers. In 2023, a substantial number of UK tourists visited India, which has experienced a sharp increase in chikungunya cases, particularly in Maharashtra and Telangana. The CDC has issued travel advisories due to the rising number of cases among returning travelers.

Dr. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), praised this development as a crucial measure in safeguarding UK travelers heading to affected regions. He stressed the need to ensure affordable access to vaccine doses in countries where the disease is prevalent. CEPI, a major investor supported by the UK government, aims to make the vaccine affordable and accessible to vulnerable populations in Low- and Middle-Income Countries (LMICs).

Valneva and CEPI formed a partnership in 2019, with backing from the EU's Horizon program, to advance the development of IXCHIQ® and enhance access for at-risk populations. Their collaboration expanded in late 2024, securing a $41.3 million grant from the EU to facilitate vaccine availability in LMICs and to support further research, including potential label extensions for children, adolescents, and pregnant women.

In a significant move, Valneva recently finalized an exclusive licensing agreement with the Serum Institute of India (SII), the largest vaccine producer by volume, to supply the vaccine across Asia. This agreement ensures priority provision at affordable prices for public health markets in LMICs. This initiative complements a previous agreement with Brazil’s Instituto Butantan to develop and distribute the vaccine in Latin America.

Chikungunya is a mosquito-transmitted disease known for causing fever, joint and muscle pain, headache, nausea, fatigue, and rash. The joint pain can be severe and long-lasting. Since 2004, chikungunya has spread globally, with over 110 countries reporting cases. The Americas alone reported over 3.7 million cases from 2013 to 2023. The World Health Organization considers chikungunya a significant public health concern, a situation expected to worsen with climate change facilitating the spread of its mosquito vectors.

Valneva, a company focused on vaccines addressing unmet medical needs, has a strong track record of taking vaccines from research to market. Its commercial success supports its pipeline of vaccine development, including candidates for Lyme disease and the Zika virus. CEPI, founded in 2017, works to accelerate vaccine development for epidemic and pandemic threats, striving for global accessibility within 100 days of a new outbreak under its '100 Days Mission.'