US FDA approves an additional indication for CAPVAXIVE in children and adolescents aged 2 through 17 at increased risk for pneumococcal disease

Merck has recently announced that the US FDA has approved an expanded indication for CAPVAXIVE, extending its use to children and adolescents aged 2 through 17 who have completed a primary pediatric pneumococcal vaccination series and carry one or more chronic medical conditions placing them at heightened risk of pneumococcal disease. With this decision, CAPVAXIVE becomes the only pneumococcal conjugate vaccine in the US specifically indicated and studied for this patient group.

CAPVAXIVE is indicated for active immunisation against invasive pneumococcal disease caused by a broad range of Streptococcus pneumoniae serotypes in individuals aged 18 and above, as well as in those aged 2 through 17 who face elevated pneumococcal disease risk. It is also indicated for active immunisation against pneumonia caused by specified S. pneumoniae serotypes in adults aged 18 and older. The therapy should not be given to anyone with a history of severe allergic reaction, such as anaphylaxis, to any of its components or to diphtheria toxoid.

The pneumonia prevention indication has been granted under accelerated approval on the basis of immune responses measured by opsonophagocytic activity. Whether this indication continues to hold may depend on the verification and further characterisation of clinical benefit through a confirmatory trial.

“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 and investigator on the 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.”

Evidence supporting the approval comes from the Phase 3 STRIDE-13 trial, which assessed CAPVAXIVE against PPSV23, a pneumococcal 23-valent polysaccharide vaccine, in children and adolescents aged 2 through 17 who had completed a primary pediatric pneumococcal vaccination series and presented with one or more chronic conditions elevating their pneumococcal disease risk.

“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 Dr. 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 expanded indication sits alongside existing primary pediatric pneumococcal vaccination programmes for at-risk children and adolescents. Drawing on a 2025 analysis of CDC surveillance data from 2015 to 2019, which included a paediatric group of children under 18 with at least one risk condition for invasive pneumococcal disease such as chronic heart disease, chronic lung disease, diabetes, or chronic kidney disease, CAPVAXIVE was found to cover the serotypes responsible for approximately 79% of invasive pneumococcal disease cases within this population. The 11 serotypes uniquely covered by CAPVAXIVE account for around 40% of invasive pneumococcal disease cases in this risk group. These figures reflect epidemiological data from the CDC and do not indicate the efficacy of CAPVAXIVE, for which no dedicated efficacy studies have yet been conducted.

---

---

Related Topics and Keywords

CAPVAXIVE, Merck, Pneumococcal disease