FDA approves Pfizer’s Prevnar 20 vaccine

The Food and Drug Administration has approved Pfizer’s Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for the prevention of invasive disease and pneumonia caused by the 20 pneumococcus serotypes in the vaccine in adults age 18 years old and older.

Following the FDA approval, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices 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 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease and have been associated with high case-fatality rates, antibiotic resistance and/or meningitis.

“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 Jansen, Pfizer senior vice president and head of vaccine research and development. “With a single injection, Prevnar 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world.”

The FDA approval was welcomed by Jane Barratt, secretary general of the International Federation on Ageing. “Adult vaccinations play a pivotal role in helping protect our health and wellness, especially as we age and our immune systems begin to naturally weaken. We are delighted with today’s approval as it addresses a critical need to continually expand coverage to meet the changing burden of disease. We encourage all adults to speak with their healthcare professionals about vaccinations.”