Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] Recent Developments - The FDA has suspended the license for Valneva's chikungunya vaccine IXCHIQ due to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, effective immediately [1][2] - This suspension follows the FDA's earlier decision to lift a recommended pause for individuals aged 60 and older, based on an investigation of reported SAEs [2] Financial Impact - IXCHIQ sales contributed €7.5 million to Valneva's total product sales of €91 million in the first half of 2025, with a significant portion attributed to a one-time delivery of vaccine doses for a chikungunya outbreak in La Reunion [4] Commitment to Safety and Access - Valneva is committed to maintaining high safety standards and will continue to engage with health authorities regarding IXCHIQ [3] - The CEO emphasized the company's commitment to providing access to IXCHIQ globally, especially in low-and-middle-income countries affected by chikungunya outbreaks [4] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, indicating the ongoing need for effective vaccines [6]

Core Viewpoint - Bavarian Nordic A/S has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its chikungunya vaccine, VIMKUNYA, aimed at individuals aged 12 and older, with a planned launch in the UK during the summer of 2025 [1][2][3]. Group 1: Vaccine Approval and Launch - The approval of VIMKUNYA follows a review under the international recognition procedure, acknowledging prior approvals from other regulatory bodies, including the European Commission [2]. - This marks the third approval for Bavarian Nordic's chikungunya vaccine, following approvals from the U.S. FDA and the European Commission in February 2025 [3]. Group 2: Disease Background - Chikungunya is a mosquito-borne disease that has emerged in over 110 countries, with significant outbreaks reported in Asia, Africa, and the Americas [4]. - In 2024, there were 620,000 reported cases of chikungunya globally, resulting in over 200 deaths, indicating a potential underreporting of the disease [4]. Group 3: Vaccine Details and Efficacy - VIMKUNYA is a single-dose, adjuvanted VLP recombinant protein vaccine designed for active immunization against chikungunya virus [5]. - Phase 3 clinical trials involving over 3,500 participants demonstrated that 21 days post-vaccination, up to 97.8% of individuals developed neutralizing antibodies [6]. Group 4: Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines, with a strong portfolio in travel vaccines and public health preparedness [7].

Core 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].