Pneumococcal 20-Valent Conjugate Vaccine Approved

New York-based Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) had approved PREVNAR 20™ for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.

PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13®. The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease (IPD) and has been associated with high case-fatality rates, antibiotic resistance, and/or meningitis.

Overall, the seven additional serotypes in PREVNAR 20 account for approximately 40% of all pneumococcal disease cases and deaths in the USA.

“Today’s approval of PREVNAR 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccines,” said Kathrin U. Jansen, Ph.D., SVP and Head of Vaccine Research & Development, Pfizer, in a press statement.

In the USA, more than half of all cases of invasive pneumococcal disease (IPD), including bacteremia and meningitis, in adults ages 65 or older are due to the 20 serotypes in PREVNAR 20. These 20 serotypes are estimated to cause up to 250,000 cases of IPD and community-acquired pneumonia and more than 10,000 deaths in adults ages 18 or older.

Following today’s FDA approval, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet in October 2021 to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults.