Pfizer gets USFDA priority review for 20-valent pneumococcal conjugate vaccine

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.

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