Valneva SE , a specialty vaccine company, announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world’s first and only chikungunya vaccine, IXCHIQ^®. The single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. The vaccine is manufactured at Valneva’s leading vaccine production site in Livingston, Scotland.

The approval is based on IXCHIQ^®’s final pivotal Phase 3 data, published in The Lancet, which included more than 4,000 participants and demonstrated that a single dose of the live-attenuated IXCHIQ^® vaccine induces a rapid and strong immune response. Data has since shown this response can be maintained for at least three years in both younger and older adults.

The UK approval marks the fourth regulatory approval Valneva has received for its single-shot chikungunya vaccine. The vaccine is currently approved in the United States (U.S.)², Europe³ and Canada⁴ in adults 18 years of age and older. Valneva expects to receive marketing approval in Brazil in the first quarter of 2025, which would represent the first approval in an endemic country. Valneva submitted label extension applications to the U.S. Food and Drug Administration (FDA)⁵, the European Medicines Agency (EMA) and Health Canada⁶ to potentially extend the use of IXCHIQ^® to adolescents aged 12 to 17 years. The Company now also plans to submit a label extension application to MHRA.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This latest approval is a further recognition of IXCHIQ^®’s strong product profile and the medical need for a chikungunya vaccine. Travelers from the UK consistently rank among India’s largest tourist groups given cultural ties and shared history. With the current outbreak in India, it is critical to ensure UK travelers have access to this vaccine, not only for their protection when travelling to India or other chikungunya endemic countries but also to prevent potential chikungunya transmission when returning to the UK. Considering the significant risk chikungunya poses to individuals living in or traveling to endemic areas, it's crucial to ensure that the vaccine is accessible to people of all ages and capable of potentially offering long-term protection from a single shot.”

In 2023, 920,000 UK travellers visited India⁷, which recorded the second highest number of chikungunya cases worldwide over five years, with 370,000 cases reported between January 2019 and July 2024⁸. The number of cases in India is rapidly increasing due to the current outbreak in the Indian states of Maharashtra and Telangana, for which the U.S. Centers for Disease Control and Prevention (CDC) issued a travel notice after identifying higher-than-expected numbers of chikungunya cases in returning travelers⁹.

Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), supporting late-stage development and broader access to the vaccine, commented, “In a warming world, mosquito-borne diseases like chikungunya are causing more frequent and severe outbreaks around the world, so it is vital that we keep people safe from this debilitating illness. Today’s MHRA approval of Valneva’s IXCHIQ^® vaccine is an important step forward in protecting UK citizens travelling to affected countries – but the fight is not over. Our work now focusses on expanding access to vaccine doses, at an affordable price, in those endemic regions. As a major investor in CEPI, the UK Government is providing vital support to advance this goal, helping to make the vaccine accessible to those in Low- and Middle- Income Countries (LMICs) who are most at risk from the disease, while also protecting their own population.”

Valneva entered a partnership with CEPI in 2019¹⁰, with support from the European Union (EU) Horizon program, to support late-stage development of IXCHIQ^® and expand access to the vaccine for at-risk populations in affected countries. Valneva and CEPI expanded their partnership in the third quarter of 2024¹¹, with support from the EU, through a $41.3 million grant to advance broader access to the vaccine in LMICs, including outbreak-affected countries, post-marketing studies and research to support potential label extensions in children, adolescents and pregnant women.

Within the framework of this partnership, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses¹², enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs.
This new agreement complements the license agreement Valneva signed in 2021 with Instituto Butantan in Brazil for the development, manufacturing and marketing of a local chikungunya vaccine at an affordable price for distribution in Latin American countries and selected LMICs affected by the disease.