Merck recently announced that the US Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2-17 years who have completed a primary pediatric pneumococcal vaccination series and have 1 or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the US for use in this patient population.

CAPVAXIVE should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.

The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Dr. Rotem Lapidot, Chief of Pediatric Infectious Diseases, Rambam Health Care Campus, investigator, STRIDE-13 trial, said, “Children and adolescents with certain chronic conditions are at an increased risk for pneumococcal disease, including pneumonia, meningitis, and bloodstream infections. This approval recognises 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.”

The approval is based on data from the phase 3 STRIDE-13 trial, which evaluated CAPVAXIVE compared to PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in children and adolescents aged 2 through 17 years who completed a primary pediatric pneumococcal vaccination series and have 1 or more chronic medical conditions that put them at an increased risk of pneumococcal disease.

Dr. Paula Annunziato, Senior Vice President (SVP), infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said, “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. 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 long-standing commitment to public health and infectious diseases.”

The expanded indication for CAPVAXIVE complements existing primary pediatric pneumococcal vaccination series for children and adolescents at increased risk for pneumococcal disease.

According to a 2025 study of 2015-2019 CDC ABC surveillance data, including 3 groups, one of which consisted of children <18 years old with at least one risk condition for invasive pneumococcal disease (IPD) such as chronic heart disease, chronic lung disease, diabetes, and Chronic Kidney Disease (CKD), CAPVAXIVE covers the serotypes responsible for ~79 percent of IPD cases. In this risk group, the 11 unique serotypes covered by CAPVAXIVE account for ~40 percent of IPD cases. These values are based on CDC epidemiologic data and do not reflect the efficacy of CAPVAXIVE. There are currently no studies evaluating the efficacy of CAPVAXIVE.