FDA approves Prevnar 20 a pneumococcal 20 valent conjugate vaccine for adults aged 18 years and older.- Pfizer.

Following this 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 (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 (IPD),and have been associated with high case-fatality rates,antibiotic resistance, and/or meningitis. The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and II trials, and three Phase III trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. More than 6,000 adult subjects 18 years and older participated in the three Phase III trials, including adults 65 years of age and older, vaccine-naïve adults, and adults with prior pneumococcal vaccination.. In the United States, more than half of all cases of invasive pneumococcal disease (IPD) – which include bacteremia and meningitis – in adults ages 65 or older are due to the 20 serotypes in Prevnar20. 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 U.S..