Pfizer Announces Positive Topline Results from Pivotal Phase 3 Trial of 20-Valent Pneumococcal Conjugate Vaccine in Infants

Intelligent Finance APP learned that Pfizer (PFE.US) announced today that its pivotal Phase 3 clinical trial for the 20-valent pneumococcal conjugate vaccine (20vPnC) to prevent infants from invasive pneumococcal disease (IPD) achieved positive topline results. This new vaccine can protect children from up to 20 serotypes of pneumococcal infections. Based on the overall safety and immunogenicity data, and following discussions with the U.S. FDA, Pfizer intends to submit a supplemental Biologics License Application (sBLA) by the end of this year.

It is reported that the 20vPnC vaccine developed by Pfizer includes the 13 serotypes contained in the marketed Prevnar 13, along with seven additional new serotypes. These seven newly added serotypes are associated with invasive pneumococcal disease (IPD), high mortality rates, antibiotic resistance, and/or meningitis.

Pneumococcal disease is caused by infection with Streptococcus pneumoniae. Pneumococcus is a Gram-positive, facultatively anaerobic bacterium with more than 90 serotypes. This bacterium can cause severe conditions such as pneumonia, meningitis, bloodstream infections, and sinus infections. The impact of this pathogen on children is different from that on adults, with children under 2 years of age being particularly susceptible to pneumococcal infections.