Pfizer's SBLA For 20vPnC Vaccine In Infants And Children Accepted By FDA For Priority Review
Pfizer Inc. (PFE) announced Friday that the U.S. Food and Drug Administration accepted for priority review a supplemental Biologics License Application or sBLA for its 20-valent pneumococcal conjugate vaccine candidate in infants and Children.
The sBLA is for the 20-valent pneumococcal conjugate or 20vPnC vaccine for the prevention of invasive pneumococcal disease or IPD caused by the 20 Streptococcus
pneumoniae (pneumococcus) serotypes contained in the vaccine in infants and
children 6 weeks through 17 years of age. It is also for the prevention of otitis
media caused by seven of the 20 Streptococcus pneumoniae serotypes contained in
Priority Review designation by the FDA reduces the standard sBLA review period by four months.
The company expects the Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the 20vPnC vaccine application 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 based on results from the Phase 3 and Phase 2 clinical trial programs for the pediatric indication for 20vPnC.
In September 2022, Pfizer announced positive top-line results from its pivotal Phase 3 study (NCT04546425) in infants in the European Union, and in November 2022, submitted the 20vPnC pediatric indication to the European Medicines Agency.
Pfizer noted that PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) was approved in 2021 for the prevention of invasive disease and pneumonia caused by the 20 pneumococcus serotypes in the vaccine in adults ages 18 years and older.
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