The US FDA has approved an expanded indication for Merck’s CAPVAXIVE, allowing its use in children and adolescents at increased risk of pneumococcal disease despite primary pneumococcal vaccination.
The move makes CAPVAXIVE )Pneumococcal 21-valent Conjugate Vaccine), the only pneumococcal conjugate vaccine specifically indicated and studied in the US for this high-risk pediatric group, according to Merck.
The expanded approval covers children and teens with chronic conditions that increase vulnerability to pneumococcal infections, including pneumonia, meningitis, and bloodstream disease.
“Children and adolescents with certain chronic conditions are at an increased risk for pneumococcal disease, including pneumonia, meningitis, and bloodstream infections,” said Dr. Rotem Lapidot, Chief of Pediatric Infectious Diseases at Rambam Health Care Campus, investigator, STRIDE-13 trial.
“This approval recognizes the potential of CAPVAXIVE to deliver additional protection by including serotypes not contained in approved primary pediatric PCV series, and represents a new approach to helping protect children and adolescents at increased risk for pneumococcal disease.”
Merck said the approval is supported by Phase 3 STRIDE-13 trial results, which compared CAPVAXIVE against PPSV23 in 874 participants aged 2 to 17 with underlying medical conditions. The study found the vaccine generated strong immune responses and was generally comparable in safety to the existing standard.
“While CAPVAXIVE was specifically designed for adults, it may also offer additional disease protection for this specific population of children and adolescents, when given after the primary pediatric pneumococcal vaccination series,” said Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories.
“The approval of CAPVAXIVE for children and adolescents at increased risk for pneumococcal disease demonstrates our commitment to addressing this disease in people of all ages, not only addressing an unmet need, but also reinforcing Merck’s longstanding commitment to public health and infectious diseases.”
The company said CAPVAXIVE targets 21 Streptococcus pneumoniae serotypes and provides coverage beyond existing pediatric vaccine series, including serotypes not previously included in routine childhood immunization programs.
Merck also highlighted epidemiological data suggesting the vaccine covers a substantial share of invasive pneumococcal disease cases in high-risk pediatric populations, though it noted these figures are based on surveillance data and not direct clinical efficacy.
The STRIDE-13 trial showed CAPVAXIVE was noninferior to PPSV23 for shared serotypes and generated stronger immune responses for several additional serotypes unique to the vaccine, with a safety profile broadly similar between the two groups.
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