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 primarily among elderly individuals with multiple underlying health conditions [2] Financial Impact - Sales of IXCHIQ® 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] - Valneva is evaluating the potential financial impact of a permanent withdrawal of the IXCHIQ® license in the United States but has not modified its revenue guidance at this time [4] Commitment to Safety and Access - Valneva is committed to upholding high safety standards and will continue to engage proactively with health authorities in all territories where IXCHIQ® is licensed [3] - The CEO emphasized the company's commitment to maintaining access to IXCHIQ® as a global health tool for addressing chikungunya outbreaks, particularly in low-and-middle-income countries [4] Chikungunya Overview - Chikungunya virus (CHIKV) is a mosquito-borne viral disease that has caused significant outbreaks globally since 2004, with over 3.7 million cases reported in the Americas between 2013 and 2023 [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, with the medical and economic burden expected to grow due to climate change [6]

Healthcare Sector Performance - Healthcare sector is negative YTD and second worst performer for Q2, behind energy [1] - UnitedHealth Group (UNH) is a significant drag, down 42% since April [1] Vaccine Advisory Committee - RFK's vaccine advisory committee is voting on the RSV vaccine and flu shot [1] - ACIP voted 5 to 2 to recommend Merck's RSV shot for newborns [2] - Concerns were raised about the safety of the immunization, leading to debate [2] - Panel will vote on flu shots, including those containing thimerosal [2] - Thimerosal is a preservative in multi-dose vaccine vials, a focus of vaccine skeptics due to mercury exposure fears [3] - New chairman announced two new work groups: one to review the childhood vaccine schedule, and another to review vaccines not reviewed in over seven years [3][4]