FDA Expands Merck Pneumococcal Shot Label To Include At-Risk Children And Teens

The FDA approved an expanded indication for Merck's Capvaxive pneumococcal vaccine, extending its use to children and adolescents ages 2-17 with chronic conditions. The approval was based on Phase 3 STRIDE-13 trial data and makes Capvaxive the only pneumococcal conjugate vaccine specifically studied and indicated for this patient group in the U.S. The vaccine covers serotypes associated with approximately 79% of invasive pneumococcal disease cases among at-risk children.