FDA extends Capvaxive to children and adolescents aged 2 to 17 at increased risk of pneumococcal disease

The FDA approved an expanded Capvaxive indication for children and adolescents aged 2 through 17 who have finished a primary pediatric pneumococcal series and have at least one chronic medical condition that raises their risk. The label covers invasive pneumococcal disease caused by 22 listed serotypes. The approval rests on immune-response data from the STRIDE-13 trial against PPSV23, and Merck notes there are no efficacy studies of Capvaxive yet.

• Ages 2 to 17 with chronic conditions, after a primary pediatric series
• Invasive disease from 22 listed serotypes
• STRIDE-13 (n=874): noninferior to PPSV23 on 12 shared serotypes
• Approval is based on immune responses; no efficacy studies yet