Vaxcyte’s Pneumococcal Vaccine Candidate Gets Breakthrough Therapy Status

The FDA has granted Breakthrough Therapy designation to Vaxcyte for its VAX-24, an investigational 24-valent pneumococcal conjugate vaccine to prevent invasive pneumococcal disease, a group of bacterial infections of blood, bones, lungs or joints.

The agency decision was based on positive results from a phase 1/2 proof-of-concept study in which VAX-24 either met or exceeded the immunogenicity standards for all 24 serotypes. The vaccine also demonstrated noninferiority in antibody response compared to Pfizer’s 20-valent pneumococcal conjugate vaccine Prevnar 20 in 20 serotypes, the company said.

Plans are underway to move the vaccine candidate into a phase 3 setting.

The Breakthrough Therapy designation is designed to expedite the development and review of drugs intended to treat a serious condition and that show promise compared with currently available therapies.