The U.S. FDA on Thursday approved an expanded indication for Merck & Co Inc.’s (NYSE:MRK) Capvaxive, extending its use to children and adolescents ages 2–17 with chronic conditions who have completed a primary pneumococcal vaccine series.
The decision makes Capvaxive the only pneumococcal conjugate vaccine specifically studied and indicated in the U.S. for this patient group.
Phase 3 STRIDE-13 data helped win approval. The data evaluated Capvaxive against PPSV23 in pediatric and adolescent patients at elevated risk of pneumococcal disease due to underlying medical conditions.
Merck said the trial formed the basis for the label expansion.
Capvaxive is already approved for adults 18 and older to help prevent invasive pneumococcal disease caused by multiple Streptococcus pneumoniae serotypes, as well as for at-risk patients aged 2–17.
The FDA had also previously granted accelerated approval for an adult pneumonia indication based on immune response data, with continued approval contingent on confirmatory clinical outcomes.
Coverage Targets Serotypes Linked To Pediatric Disease Risk
According to a 2025 analysis of CDC ABC surveillance data from 2015 to 2019, Capvaxive covers serotypes associated with approximately 79% of invasive pneumococcal disease cases among children under 18 with at least one risk condition.
Merck added that the 11 serotypes uniquely covered by Capvaxive accounted for about 40% of invasive pneumococcal disease cases within that risk group.
In March, Pfizer Inc. (NYSE:PFE) reported positive Phase 2 data for its investigational 25-valent pneumococcal conjugate vaccine candidate.
The vaccine candidate, known as 25vPnC, generated notably stronger immune responses against serotype 3, a major remaining cause of invasive pneumococcal disease and complicated pneumonia in children.
MRK Stock Price Activity: Merck & Co shares were down 2.95% at $112.03 at the time of publication on Thursday, according to Benzinga Pro data.
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