Vaxcyte's Pneumococcal Vaccine For Infants Shows Promising Results

Vaxcyte Inc., a clinical-stage vaccine innovation company, has announced that the first clinical participants started receiving the VAX-31, a pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD) in healthy infants. Doses were received during the Phase 2 trials in healthy infants in the second and final evaluation stage. The scientific committee performs a blinded assessment of safety and tolerability data according to the study protocol to progress into Stage 2. An assessment of VAX-31 safety, together with tolerability and immunogenicity, takes place in healthy infants as a part of this investigation. The sharing of topline data for the primary three-dose immunization series of the study is projected by VAX Pharmaceuticals to occur in mid-2026, followed by topline data from the booster dose around nine months later.

Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte said in a statement, “Advancing to Stage 2 of the VAX-31 infant Phase 2 study represents a significant step forward in evaluating the broadest vaccine candidate in the clinic today for this vulnerable population. PCVs have been a bedrock of the vaccination schedule for decades, providing critical protection against invasive pneumococcal disease for our communities. With our PCV franchise, VAX-24 and VAX-31, we are working to set a new standard that expands protection against currently and historically circulating strains while maintaining strong immune responses. We look forward to sharing topline data for safety, tolerability and immunogenicity from the VAX-31 infant study primary immunization series in mid-2026 and from the booster dose approximately nine months later.”

“PCVs have demonstrated the ability to deliver herd immunity to protect against devastating diseases caused by Streptococcus pneumoniae bacteria, and our technology has the potential to deliver best-in-class PCVs with broader coverage for both infants and adults. Based on the body of positive evidence from the VAX-31 and VAX-24 adult Phase 1/2 programs, we believe our carrier-sparing platform has the potential to set a new standard in disease coverage,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte.