Vaxcyte Provides Positive Regulatory Updates on VAX-31 Pediatric and Adult Programs

Core Insights - Vaxcyte, Inc. has received FDA clearance for the VAX-31 infant Investigational New Drug (IND) application and Breakthrough Therapy designation for adults, marking significant regulatory milestones for the company [1][6][7] - VAX-31 is a 31-valent pneumococcal conjugate vaccine (PCV) designed to prevent invasive pneumococcal disease (IPD) in both pediatric and adult populations, with coverage estimates of approximately 94% for children under five and over 95% for adults in the U.S. [2][12] - The company plans to initiate a Phase 2 study for infants by the end of January 2025 and a Phase 3 pivotal study for adults by mid-2025 [1][3][10] Regulatory Milestones - The FDA's clearance of the VAX-31 infant IND application allows for a Phase 2 study that will include a primary immunization series of three doses at two, four, and six months, followed by a booster at 12-15 months [4] - The Breakthrough Therapy designation for VAX-31 in adults is based on positive topline results from the Phase 1/2 study, which supports the advancement to a Phase 3 program [6][7] Clinical Development Plans - Vaxcyte aims to announce topline safety, tolerability, and immunogenicity data from the VAX-31 infant Phase 2 study in mid-2026, with booster dose data expected approximately nine months later [10] - The company is also advancing its VAX-24 candidate, with topline data from its Phase 2 study expected by the end of Q1 2025 [9] Disease Context - IPD remains a significant health threat, particularly in children under five, with approximately 300,000 deaths annually due to Streptococcus pneumoniae, highlighting the need for broader-spectrum vaccines like VAX-31 [5][11] - Pneumococcal disease is a leading cause of vaccine-preventable deaths in young children and is associated with high hospitalization rates in the U.S. [11][12] Company Overview - Vaxcyte is focused on developing high-fidelity vaccines to combat bacterial diseases, with VAX-31 being the broadest-spectrum PCV candidate currently in clinical trials [13] - The company utilizes advanced synthetic techniques for vaccine development, aiming to improve upon existing vaccines by covering more serotypes responsible for significant disease burden [13]