FDA gives priority review to sBLA for 20vPnC in pneumococcal disease.- Pfizer
Pfizer announced that the FDA accepted for priority review a supplemental Biologics License Application (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) 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 (PDUFA) 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.
The regulatory submission is supported by results from the Phase III and Phase II clinical trial programs for the pediatric indication for 20vPnC. Three core Phase III pediatric studies contributed to data on the safety, tolerability, and immunogenicity of 20vPnC, including previously announced positive, top-line results of the pivotal U.S. Phase III study (NCT04382326). These studies collectively enrolled approximately 3,500 infants and 800 children of all ages. Further data from a Proof-of-Concept Phase II study (NCT03512288) in 460 U.S. infants that assessed the safety and immunogenicity of 20vPnC, with previously announced positive results, also supported the regulatory submission.
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