FDA Expands CAPVAXIVE Pediatric Use

Phase 3 data showed noninferior immune responses vs pneumococcal 23-valent polysaccharide vaccine in pediatric patients at increased risk.

By
Kathryn Wighton
June 18, 2026
2 min

MDSpire News

Overview

The FDA has expanded the indication for CAPVAXIVE to include patients aged 2 to 17 years with chronic medical conditions at risk for pneumococcal disease. This decision is supported by findings from the Phase 3 STRIDE-13 study, which demonstrated noninferior immune responses compared to the pneumococcal 23-valent polysaccharide vaccine.

Background

Pneumococcal disease poses a significant risk to pediatric patients with chronic medical conditions. Vaccination is crucial for this population to prevent invasive pneumococcal disease. The expansion of CAPVAXIVE's indication highlights the ongoing efforts to improve vaccine accessibility and coverage among at-risk children.

Data Highlights

Study	Participants	Findings
Phase 3 STRIDE-13	874 pediatric patients	Noninferiority for shared serotypes with PPSV23
Safety Profile	CAPVAXIVE: 5.5% serious AEs	PPSV23: 7.2% serious AEs
Immune Response	Higher for CAPVAXIVE unique serotypes	Noninferior for serotype 15B

Key Findings

The FDA expanded CAPVAXIVE's indication for children aged 2 to 17 years with chronic medical conditions.
CAPVAXIVE demonstrated noninferior immune responses compared to PPSV23 for shared serotypes.
Immune responses for serotypes unique to CAPVAXIVE were higher than those for PPSV23.
Serious adverse events were comparable between CAPVAXIVE and PPSV23 groups.
One serious adverse event related to vaccination was reported in the CAPVAXIVE group.

Clinical Implications

Healthcare providers should consider CAPVAXIVE for pediatric patients aged 2 to 17 years with chronic medical conditions who have completed a primary pneumococcal vaccination series. Monitoring for adverse events remains essential, although the safety profile appears comparable to existing vaccines.

Conclusion

The expansion of CAPVAXIVE's indication represents a significant advancement in the prevention of pneumococcal disease among at-risk pediatric populations. Ongoing surveillance and further studies will be important to assess long-term efficacy and safety.