Pfizer: FDA accepts for priority review sBLA for 20vPnC

Pfizer announced that the U.S. FDA accepted for priority review a supplemental Biologics License Application for its 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine in infants and children 6 weeks through 17 years of age, and for the prevention of otitis media caused by seven of the 20 Streptococcus pneumoniae serotypes contained in the vaccine. Priority Review designation by the FDA reduces the standard sBLA review period by four months. The Prescription Drug User Fee Act goal date for a decision by the FDA on the 20vPnC vaccine application is anticipated in April 2023. The FDA previously granted Pfizer’s 20vPnC Fast Track Designation in May 2017 and Breakthrough Therapy Designation in August 2020 for the pediatric indication for IPD.