Merck said the FDA has approved an additional indication for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine), allowing its use in children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that increase their risk for pneumococcal disease. In the U.S., CAPVAXIVE is now the only pneumococcal conjugate vaccine specifically indicated and studied for this high-risk pediatric and adolescent population. The expanded label complements existing pediatric pneumococcal vaccine series by adding coverage for serotypes not included in approved primary regimens.
CAPVAXIVE is indicated for active immunization to prevent invasive pneumococcal disease caused by 21 Streptococcus pneumoniae serotypes in adults 18 years and older and in high-risk individuals 2 through 17 years of age. It is also indicated, under accelerated approval, to prevent pneumonia caused by those same serotypes in adults 18 years and older, based on immune responses measured by opsonophagocytic activity; continued approval for the pneumonia indication may depend on confirmatory data demonstrating clinical benefit. The vaccine should not be given to individuals with a history of severe allergic reaction, including anaphylaxis, to any component of CAPVAXIVE or to diphtheria toxoid.
The new pediatric and adolescent indication is supported by results from the Phase 3 STRIDE-13 trial, which compared CAPVAXIVE with the 23‑valent pneumococcal polysaccharide vaccine (PPSV23) in 2- to 17-year-olds who had completed a primary pneumococcal series and had at least one chronic medical condition that put them at greater risk of pneumococcal disease. Investigators highlighted that children and adolescents with conditions such as chronic heart, lung, kidney disease or diabetes face higher risks of outcomes including pneumonia, meningitis and bloodstream infections.
Merck noted that CAPVAXIVE was initially developed for adults but may offer additional protection when used after standard pediatric series in this specific younger population. Citing a 2025 analysis of CDC Active Bacterial Core surveillance data from 2015–2019 in children under 18 with at least one risk condition for invasive pneumococcal disease, the company said CAPVAXIVE’s serotype coverage corresponds to about 79% of invasive cases in that group, with its 11 unique serotypes accounting for roughly 40%. These estimates are based on epidemiologic data and do not represent direct vaccine efficacy; no efficacy studies of CAPVAXIVE are currently available.
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