Overview
- The FDA approved the label expansion on Thursday to allow Capvaxive for children and adolescents aged 2–17 who completed the standard pediatric pneumococcal series and have chronic conditions that raise their risk of invasive disease.
- Approval was supported by Phase 3 STRIDE‑13 data from 874 participants showing Capvaxive produced immune responses that were noninferior or superior to the older PPSV23 vaccine.
- Merck reports side effects were generally short lived and that the vaccine is given as a single dose intended to add protection for vulnerable youth rather than replace routine childhood pneumococcal shots.
- A 2025 analysis of CDC Active Bacterial Core surveillance data found Capvaxive’s serotypes match about 79% of invasive pneumococcal cases in children with risk conditions and that 11 serotypes uniquely covered by the vaccine accounted for roughly 40% of cases in that group.
- Policy and uptake remain to be set because federal recommendation and insurance coverage depend on CDC advisory review and guidance, and vaccine competition is ongoing as Pfizer advances a 25‑valent candidate that shows stronger responses against serotype 3.