Valneva(US:VALN) Newsfilter·2025-03-31 05:00Core Insights - Valneva SE has submitted a label extension application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) to expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years, following a positive opinion from the European Medicines Agency (EMA) for the same extension in the EU [1][2]. Company Developments - IXCHIQ® is the world's first licensed chikungunya vaccine, currently approved for individuals aged 18 and older in the U.S., Europe, Canada, and the UK [2][3]. - Valneva has committed to supplying 40,000 doses of IXCHIQ® to La Réunion, responding to a call from the French government amid ongoing chikungunya outbreaks [3][4]. - The company is focused on expanding the vaccine's accessibility, with positive Phase 3 data showing a 99.1% immune response in adolescents after a single dose, and a sustained 98.3% sero-response rate one year post-vaccination [4][5]. Partnerships and Funding - In Q3 2024, Valneva expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) through a $41.3 million grant aimed at increasing vaccine access in low- and middle-income countries (LMICs) [5][6]. - An exclusive license agreement was signed with the Serum Institute of India to supply IXCHIQ® in Asia, ensuring affordable pricing for public health markets in LMICs [6][7]. - Valneva previously established a license agreement with Instituto Butantan in Brazil for a local chikungunya vaccine, further enhancing its distribution capabilities in Latin America [7]. Public Health Context - Chikungunya has emerged as a significant public health concern, with outbreaks reported in India, Brazil, and La Réunion, and the World Health Organization (WHO) has identified it as a major public health problem [3][9]. - The chikungunya virus has been reported in over 110 countries since its re-emergence in 2004, with over 3.7 million cases documented in the Americas between 2013 and 2023 [9].