European Medicines Agency Accepts Pfizer’s Marketing Authorization Application for Its Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years of Age or Older

Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) 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. With the MAA acceptance, the formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) begins.

“The epidemiology of pneumococcal serotypes causing disease has been changing due to the success of pneumococcal conjugate vaccines targeting pediatric and adult populations. In many countries across Europe and around the world, more than half of all cases of invasive pneumococcal disease in older adults are due to the 20 serotypes covered in 20vPnC, including seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that are not included in any currently licensed pneumococcal conjugate vaccine,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer. “20vPnC builds on the legacy of Prevenar and Prevnar 13 and our more than two decades of experience and innovation in developing pneumococcal conjugate vaccines. Today’s acceptance of the 20vPnC application in the European Union is a significant step forward in our continuing efforts to potentially provide adults with robust and meaningful protection against more pneumococcal disease-causing serotypes.”

The 20vPnC MAA 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 pneumococcal 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, vaccine-naïve adults, and adults with prior pneumococcal vaccination.^i,ii