FDA approves Pfizer’s pneumococcal 20 vaccine

June 10, 2021

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older.

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

PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13 and conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease.

According to Pfizer, more than half of all cases of invasive pneumococcal disease (IPD) – which include bacteremia and meningitis – in adults ages 65 or older in the United States are due to the 20 serotypes in PREVNAR 20. In the United States, these 20 serotypes are estimated to cause up to 250,000 cases of IPD (including bacteremia and meningitis) and community-acquired pneumonia and more than 10,000 deaths in adults ages 18 or older. Overall, the seven additional serotypes in PREVNAR 20 account for approximately 40 percent of all pneumococcal disease cases and deaths in the United States.

On September 20, 2018, Pfizer had announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for PREVNAR 20 for the prevention of invasive disease and pneumonia in adults 18 years or older.

Visit Pfizer for more news