Objective:

To expand the indication for CAPVAXIVE for pediatric patients aged 2 to 17 years with chronic medical conditions that increase the risk of pneumococcal disease who have completed a primary pneumococcal vaccination series.

Approach:

Key Findings:

• CAPVAXIVE is indicated for the prevention of invasive pneumococcal disease in at-risk pediatric patients.
• Efficacy studies have not been conducted; estimates are based on epidemiological data rather than direct vaccine efficacy.
• Serious adverse events occurred in 5.5% of CAPVAXIVE recipients compared to 7.2% for the comparator vaccine.

Interpretation:

CAPVAXIVE is indicated in the US for patients aged 2 to 17 years with increased risk for pneumococcal disease.

Limitations:

• Efficacy studies have not been conducted for CAPVAXIVE.
• Estimates of coverage are based on epidemiological data rather than direct vaccine efficacy.

Conclusion:

CAPVAXIVE's indication expansion allows for prevention in a vulnerable pediatric population.

Sources:

• Merck & Co, Inc
Source

Based on findings from:

FDA Expands CAPVAXIVE Pediatric Use

Kathryn Wighton. MDSpire News, 2026.

https://news.mdspire.com/pediatrics/articles/fda-expands-capvaxive-pediatric-use/

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