January 25, 2023
Healio relays Pfizer’s announcement that the FDA will proceed with a priority review of its supplemental biologics license application for a 20-valent pneumococcal conjugate vaccine for infants and children aged six weeks to 17 years. The vaccine had previously received fast track designation and breakthrough therapy designation for adults and children. It is designed to prevent invasive pneumococcal disease caused by 20 serotypes of Streptococcus pneumoniae, and otitis media caused by seven bacteria serotypes.
In the story, Pfizer shares that its submission was built on positive results from phase 2 and phase 3 clinical trial programs. It was also supported by phase 2 proof-of-concept data. A quoted Pfizer spokesperson said its conjugate vaccine advances the company’s efforts to help infants and children battle the disease. The spokesperson went on to say that, if approved, the vaccine can expand protection in the age group.
PIDS member Elaine Tuomanen commented on the development, “The new vaccine formulation Pfizer has submitted for FDA approval increases the number of capsular serotypes that pneumococcal vaccines protect against from 15 to 20. Each small increment in the breadth of protection is important to child health as the inevitability of serotype escape threatens existing formulations. One can hope that eventually new vaccine strategies will address the full diversity of over 100 serotypes of this leading pediatric pathogen.”