EMA accepts filing of 20vPnC for pneumococcal disease.- Pfizer

Pfizer announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for 20vPnC, the 20-valent pneumococcal conjugate vaccine 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. With the MAA acceptance, the formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) begins. The 20vPnC MAA submission encompasses data from Pfizer’s clinical program in adults, which includes Phase I and II trials and three Phase III 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 pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults 18 years or older. The three Phase III trials have enrolled more than 6,000 adult subjects, 18 years and older, including adults 65 years of age and above, vaccine-naïve adults, and adults with prior pneumococcal vaccination.