Merck received FDA approval for the expanded use of its pneumococcal vaccine, CAPVAXIVE. The new indication covers children and adolescents aged 2 through 17 at higher risk of disease due to chronic health conditions.
The approval applies to patients who have already completed a primary pediatric pneumococcal vaccination series. Merck based the application on data from the Phase 3 STRIDE-13 clinical trial.
CAPVAXIVE is now the only U.S. pneumococcal conjugate vaccine specifically indicated for this high-risk pediatric population. This regulatory milestone potentially boosts future revenue for the company.