Merck has announced FDA approval for CAPVAXIVE™, a 21-valent pneumococcal vaccine designed for adults aged 18 and older to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes. CAPVAXIVE targets serotypes responsible for 84% of invasive pneumococcal disease cases in adults 50 years and older. Clinical trials showed robust immune responses in both vaccine-naïve and experienced populations. The CDC is expected to discuss recommendations for CAPVAXIVE use in adults. The vaccine covers more IPD cases than PCV20, with unique serotypes not found in other vaccines. CAPVAXIVE is administered in a single dose and has a comparable safety profile to existing vaccines. The approval is based on data from Phase 3 trials demonstrating safety and efficacy across various adult populations. This approval marks a significant advancement in protecting adults against pneumococcal diseases.