Pfizer BLA Accepted for Pneumococcal Conjugate Vaccine

FDA has accepted for priority review a Pfizer BLA for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate and its use for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults ages 18 years and older. The submission is based on data from Pfizer’s clinical program in adults, which includes Phase 1 and 2 trials and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975). The agency has set a user fee review action target date of June 2021.

Pfizer says it vaccine includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13 (pneumococcal 13-valent conjugate vaccine). It also contains capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease that have been associated with high case-fatality rates, antibiotic resistance, and meningitis.