FDA will review Pfizer’s 20-valent pneumococcal vaccine for children, infants

The FDA has accepted for priority review a supplemental biologics license application for Pfizer’s 20-valent pneumococcal conjugate vaccine for use in infants and children aged 6 weeks to 17 years, Pfizer announced.

The 20-valent pneumococcal conjugate vaccine candidate (20vPnC) is designed to prevent invasive pneumococcal disease caused by 20 serotypes of Streptococcus pneumoniae, and otitis media caused by seven serotypes of the bacteria. The vaccine was previously granted fast track designation in 2017 and has also received breakthrough therapy designation for adults and children.

Pfizer said its submission was supported by positive data from phase 2 and 3 clinical trial programs, as well as positive data from a proof-of-concept phase 2 study.

“Today’s regulatory milestone further advances Pfizer’s commitment to the more than 20-year legacy of helping protect infants and children from invasive pneumococcal disease through conjugate vaccination,” Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer, said in the release.

“By offering the broadest serotype coverage by a pneumococcal conjugate vaccine against important serotypes causing pneumococcal disease in U.S. infants and children, 20vPnc, if approved, can help expand the protection for this vulnerable pediatric population,” Anderson said.

A decision on the application is expected in April.