Merck received FDA approval for an expanded indication of its CAPVAXIVE vaccine. The approval covers children and adolescents aged 2 through 17 with underlying medical conditions. These conditions place the patients at higher risk for pneumococcal disease.
CAPVAXIVE is the only pneumococcal conjugate vaccine indicated for this specific U.S. patient population. The FDA based the decision on results from the Phase 3 STRIDE-13 clinical trial.
The expanded label protects against serotypes not included in existing primary pediatric vaccination series. This approval addresses an unmet need for vulnerable pediatric groups and strengthens Merck’s vaccine portfolio. Merck shares saw a modest gain following the announcement.