December 10, 2020 – Pfizer Inc. (New York, NY) announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the 20vPnC application is in June 2021.
Pfizer’s 20vPnC vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine[Diphtheria CRM197 Protein]).
The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease (IPD) and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis.
Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually.
Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally, the company says.