S4V2 Shigella Vaccine - (CHIM study)

May 13, 2026: Valneva SE (NASDAQ: VALN; Paris: VLA) reported Q1 2026 results and provided pipeline/regulatory updates. For its Lyme disease vaccine candidate LB6V (formerly VLA15; partnered with Pfizer), the companies announced in March 2026 Phase 3 VALOR topline data showing >70% efficacy in preventing Lyme disease in individuals aged ≥5 years, with no safety concerns identified; Pfizer is planning regulatory submissions to authorities (LB6V has FDA Fast Track designation). For chikungunya vaccine IXCHIQ/VLA1553, a Pilot Vaccination Strategy in Brazil initiated February 2026 is ongoing and intended to support post-marketing commitments; >30,000 adults (18–59) have been vaccinated. In early May 2026, ANVISA authorized Instituto Butantan to locally manufacture a version of the vaccine, and the vaccine is approved in Brazil for ages 18–59 with potential incorporation into the Unified Health System. For Shigella vaccine candidate S4V2 (with LimmaTech Biologics), two Phase 2 studies (infant safety/immunogenicity and a Phase 2b human challenge trial) are ongoing, with first Phase 2 results expected mid-2026; Valneva would take over further development if both are positive.