Pfizer Announces FDA Approval of Prevnar 20 for Adults Aged 18 and Older

Pfizer announced today that the U.S. FDA has approved Prevnar 20 (20-valent pneumococcal conjugate vaccine) for use in adults aged 18 years and older to prevent invasive disease and pneumonia caused by the 20 pneumococcal serotypes contained in the vaccine.

The press release states that this marks the first approval of a conjugate vaccine targeting 20 pneumococcal serotypes responsible for the majority of invasive disease and pneumonia, including 7 serotypes that account for 40% of pneumococcal disease cases and deaths in the United States.

Pfizer's clinical program in adults includes Phase 1 and Phase 2 clinical trials, as well as three Phase 3 clinical trials describing vaccine safety and evaluating immunogenicity. Over 6,000 adult subjects aged 18 years and older participated in the three Phase 3 trials, including adults aged 65 years and older, unvaccinated adults, and adults with a history of pneumococcal vaccination.