Breakthrough Designation to Vaxcyte’s VAX-24 for IPD Prevention
The 24-valent pneumococcal conjugate vaccine, “VAX-24” from Vaxcyte has been given Breakthrough Therapy status by the US Food and Drug Administration (FDA) in order to prevent invasive pneumococcal illness in adults.
The decision was based on topline findings from a Phase I/II proof-of-concept research that assessed the immunogenicity, safety, and tolerability of VAX-24 in people ages 18 to 64.
VAX-24 demonstrated a safety profile identical to Prevnar 20 (PCV20) for all dosages examined, meeting the key safety and tolerability objectives. The study also showed that VAX-24, when administered at the typical 2.2 mcg dose, met or exceeded the regulatory immunogenicity requirements for each of the 24 serotypes.
At this dose, VAX-24 met the standard opsonophagocytic activity response non-inferiority criterion for all 20 serotypes shared by PCV20, 16 of which induced more potent immune responses.
With the designation of a "Breakthrough Therapy," Vaxcyte will have access to all aspects of the FDA's Fast Track programme.
