FDA Expands approval of 21-valent pneumococcal vaccine Capvaxive for High-Risk Children

With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the U.S. for use in this patient population.

CAPVAXIVE is indicated for:

• Active immunization for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older and individuals 2 through 17 years of age who are at increased risk for pneumococcal disease;
• Active immunization 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 in individuals 18 years of age and older.

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; see additional Select Safety Information below.

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.

“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.”

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 one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. See “STRIDE-13 Clinical Data Supporting Approval” below for additional details.

“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 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 three groups, one of which consisted of children <18 years old (age range 31 to 109 months; n=219) with at least one risk condition for invasive pneumococcal disease (IPD) such as chronic heart disease, chronic lung disease, diabetes, and chronic kidney disease, CAPVAXIVE covers the serotypes responsible for ~79% of IPD cases. In this risk group, the 11 unique serotypes covered by CAPVAXIVE account for ~40% 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.

About CAPVAXIVE

CAPVAXIVE is Merck’s 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older and for the prevention of invasive disease in children and adolescents aged 2 through 17 years who have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. CAPVAXIVE was specifically designed to help address the Streptococcus pneumoniae serotypes predominantly responsible for IPD in adults, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other approved pneumococcal vaccines. CAPVAXIVE is administered as a single dose.

CAPVAXIVE helps provide coverage against the serotypes responsible for approximately 82% of IPD cases in adults 50 years of age and older, compared to ~54% by PCV20, based on national-level CDC data from 2019-2023. These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20.

With this approval, CAPVAXIVE is also indicated for the prevention of invasive disease in children and adolescents aged 2 through 17 years who have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease.

Select Safety Information for CAPVAXIVE in Children and Adolescents at Increased Risk for Pneumococcal Disease in the U.S.

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

Syncope may occur with administration of injectable vaccines.

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.

The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).

The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).

The most commonly reported (>10%) solicited adverse reactions in individuals 2 through 17 years of age who are at increased risk for pneumococcal disease were: injection-site pain (67.7%), injection-site erythema (24.3%), fatigue (20.1%), injection-site swelling (18.8%), headache (17.1%), malaise (13.3%), and irritability (11.6%).

Vaccination with CAPVAXIVE may not protect all vaccine recipients.