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

The FDA has accepted for precedence reappraisal a supplemental biologics licence exertion for Pfizer’s 20-valent pneumococcal conjugate vaccine for usage successful infants and children aged 6 weeks to 17 years, Pfizer announced.

The 20-valent pneumococcal conjugate vaccine campaigner (20vPnC) is designed to forestall invasive pneumococcal disease caused by 20 serotypes of Streptococcus pneumoniae, and otitis media caused by 7 serotypes of the bacteria. The vaccine was antecedently granted accelerated way designation successful 2017 and has besides received breakthrough therapy designation for adults and children.

The FDA accepted a supplemental biologics licence exertion for precedence reappraisal of pneumococcal conjugate vaccine for usage successful children and infants. Source: Adobe Stock

Pfizer said its submission was supported by affirmative information from signifier 2 and 3 objective proceedings programs, arsenic good arsenic affirmative information from a proof-of-concept signifier 2 study.

“Today’s regulatory milestone further advances Pfizer’s committedness to the much than 20-year bequest of helping support infants and children from invasive pneumococcal illness done conjugate vaccination,” Annaliesa Anderson, PhD, elder vice president and main technological serviceman of vaccine probe and improvement astatine Pfizer, said successful the release.

“By offering the broadest serotype sum by a pneumococcal conjugate vaccine against important serotypes causing pneumococcal illness successful U.S. infants and children, 20vPnc, if approved, tin assistance grow the extortion for this susceptible pediatric population,” Anderson said.

A determination connected the exertion is expected successful April.