The US Food and Drug Administration has expanded the indication for CAPVAXIVE for 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, according to Merck.

The decision was supported by findings from the Phase 3 STRIDE-13 study of 874 pediatric patients with underlying conditions, including diabetes mellitus and chronic heart, kidney, liver, or lung disease.

Merck cited surveillance data indicating that CAPVAXIVE covers serotypes associated with approximately 79% of invasive pneumococcal disease cases among pediatric patients with at least one risk condition. The company noted that the estimates are based on epidemiologic data rather than vaccine efficacy and that efficacy studies have not been conducted.

Investigators reported that immune responses met noninferiority criteria for serotypes shared with pneumococcal 23-valent polysaccharide vaccine and were higher for serotypes unique to CAPVAXIVE. A post hoc analysis also found noninferior responses for serotype 15B.

The safety profile was generally comparable between treatment groups. Serious adverse events within 6 months following vaccination occurred in 5.5% of patients who received CAPVAXIVE and 7.2% of those who received pneumococcal 23-valent polysaccharide vaccine. According to Merck, there were no notable patterns or imbalances in serious adverse events between groups. One serious adverse event considered related to vaccination was reported in the CAPVAXIVE group: a Grade 2 syncope event requiring hospitalization that occurred approximately 3 minutes following vaccination.

CAPVAXIVE is indicated for the prevention of invasive pneumococcal disease in patients aged 2 to 17 years who are at increased risk for pneumococcal disease. Merck states that CAPVAXIVE is the only pneumococcal conjugate vaccine specifically studied and indicated in the US for this population.

Source: Merck & Co, Inc