VAX-24 Pneumococcal Vaccine Receives FDA Fast Track Designation
California-based Vaxcyte, Inc. today announced that the U.S. FDA granted Fast Track designation to VAX-24, the Company’s 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in adults ages 18 and older.
IPD causes many clinical syndromes, depending on the site of infection (e.g., bacteremia, meningitis.), says the U.S. CDC.
The Company also completed a successful pre-Investigational New Drug meeting with the FDA regarding the VAX-24 pediatric program.
Vaxcyte received positive written feedback from the FDA supporting the initiation of a pediatric study that proceeds directly into infants, contingent on satisfactory topline safety, tolerability, and immunogenicity results from the ongoing VAX-24 Phase 1/2 clinical proof-of-concept study in adults 18 to 64 years of age.
This approach provides the Company with an accelerated clinical path to deliver a potentially best-in-class PCV, VAX-24, to the pediatric population, representing the most significant portion of the pneumococcal vaccine market in the USA.
“Despite high vaccination rates, a broader spectrum PCV remains an important public health need, especially in vulnerable populations such as infants and older adults, due to substantial disease driven by emerging serotypes not covered by currently available vaccines,” said Jim Wassil, EVP, and COO of Vaxcyte, in a press release on August 4, 2022.
Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum vaccines, such as VAX-24, by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform.
Vaxcyte is deploying this approach with VAX-24 to add more pneumococcal strains without compromising the overall immune response.
August 5, 2022
