Vaxcyte Provides Positive Regulatory Updates on VAX-31 Pediatric and Adult Programs
-- VAX-31 Infant Indication: Investigational New Drug Application Cleared by FDA; Company Expects to Initiate VAX-31 Infant Phase 2 Study by the End of January 2025 -- -- VAX-31 Adult Indication: Breakthrough Therapy Designation Granted by FDA; Company Plans to Initiate Adult Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 -- -- VAX-31, Designed to Cover Currently Circulating and Historically Prevalent Strains, is Being Studied for the Prevention of Invasive Pneumococcal Disease in the Pediatric and A ...