Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ®

Core Points - Valneva SE has received marketing authorization from the UK for IXCHIQ®, the world's first chikungunya vaccine, which is a single-dose vaccine for individuals aged 18 and older [1][3] - The approval is based on Phase 3 data showing that IXCHIQ® induces a strong immune response that lasts for at least three years [2] - Valneva has received regulatory approvals for IXCHIQ® in the US, Europe, and Canada, and expects approval in Brazil in Q1 2025 [3] Regulatory Approvals - The UK approval is the fourth for IXCHIQ®, which is already approved in the US, Europe, and Canada for adults aged 18 and older [3] - Valneva is pursuing label extension applications to include adolescents aged 12 to 17 in the US, Europe, Canada, and the UK [3] Market Context - The approval comes amid a chikungunya outbreak in India, where 370,000 cases were reported from January 2019 to July 2024, highlighting the need for vaccination among travelers [4] - In 2023, 920,000 UK travelers visited India, making it crucial to provide access to IXCHIQ® for their protection [4] Partnerships and Funding - Valneva has partnered with CEPI to support late-stage development and expand access to IXCHIQ® in low- and middle-income countries (LMICs) [5][6] - CEPI has provided a $41.3 million grant to Valneva to enhance access to the vaccine in LMICs and support post-marketing studies [5][6] Production and Distribution - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ® in Asia at affordable prices for public health markets [6] - The company also has a license agreement with Instituto Butantan in Brazil for local chikungunya vaccine development and distribution [7] Disease Overview - Chikungunya is a mosquito-borne viral disease causing severe joint pain and other symptoms, with significant outbreaks reported globally since 2004 [8][9] - The World Health Organization has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change [9]