Pfizer Inc. today 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.

“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, Ph.D., Senior Vice President 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. Importantly, 20vPnC has shown to induce immune memory, which provides protection and efficacy against non-bacteremic pneumonia, particularly in older adults.”

Pfizer’s 20vPnC vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine[Diphtheria CRM 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 20vPnC regulatory submission encompasses data from Pfizer’s clinical program in adults, which includes Phase 1 and 2 trials and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine candidate to support licensure for an indication to prevent invasive disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults 18 years or older. The three Phase 3 trials have enrolled more than 6,000 adult subjects, 18 years and older, including adults 65 years of age and above, and populations of vaccine-naïve adults and adults with prior pneumococcal vaccination.21,22