The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) candidate (Pfizer) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years and older.
The 20vPnC vaccine candidate consists of capsular polysaccharide conjugates for the 13 serotypes included in Prevnar 13® (Pfizer), along with 7 additional serotypes that cause invasive pneumococcal disease.
The BLA is supported by efficacy and safety data from the Company’s clinical development program for 20vPnC in adults, which includes three phase 3 trials (NCT03760146, NCT03828617, NCT03835975). The phase 3 development program assessed 20vPnC in more than 6000 adults aged 18 years and older, including those aged 65 years and older, vaccine-naive adults and those with prior pneumococcal vaccination.
A Prescription Drug User Fee Act (PDUFA) target date of June 2021 has been set for this application.
“The FDA’s acceptance of our application for 20vPnC is yet another significant milestone in Pfizer’s continuing efforts to help protect adults against pneumococcal disease,” said Kathrin U. Jansen, PhD, SVP and Head of Vaccine Research and Development, Pfizer. “If approved, 20vPnC will cover more serotypes responsible for the majority of pneumococcal disease than any other pneumococcal conjugate vaccine currently licensed or currently in late-stage clinical development.”
The FDA previously granted Fast Track and Breakthrough Therapy designations to 20vPnC for this indication.
For more information visit pfizer.com.
U.S. FDA accepts for priority review the Biologics License Application for Pfizer’s investigational 20-valent pneumococcal conjugate vaccine for adults 18 years of age and older. [press release]. New York, NY: Pfizer, Inc; December 8, 2020.