Merck Receives FDA Approval to Expand Capvaxive Use for At-Risk Children and Adolescents

Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine). The approval now includes children and adolescents aged 2 to 17 years who have completed a primary pneumococcal vaccination series and have one or more chronic medical conditions that increase their risk of pneumococcal disease.
The approval marks an important milestone for the vaccine, making Capvaxive the only pneumococcal conjugate vaccine specifically studied and indicated in the United States for this patient population.
Expanded Protection for High-Risk Pediatric Patients
Children and adolescents living with chronic conditions face a greater risk of developing serious pneumococcal infections. These infections can lead to complications such as pneumonia, meningitis, and bloodstream infections.
Capvaxive is now approved to help protect children and adolescents who are at increased risk for pneumococcal disease after they have completed their primary pediatric vaccination schedule.
The vaccine is already approved for adults aged 18 years and older for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by specific Streptococcus pneumoniae serotypes.
What Makes Capvaxive Different?
According to Merck, Capvaxive was designed to target pneumococcal serotypes that continue to cause significant disease burden.
Dr. Rotem Lapidot, Chief of Pediatric Infectious Diseases at Rambam Health Care Campus and investigator in the STRIDE-13 trial, said that children and adolescents with chronic medical conditions remain vulnerable to pneumococcal disease despite existing vaccination programs.
He noted that Capvaxive includes serotypes not covered by currently approved primary pediatric pneumococcal vaccine series, offering an additional layer of protection for high-risk patients.
Phase 3 STRIDE-13 Trial Supported Approval
The FDA approval is supported by findings from the Phase 3 STRIDE-13 clinical trial.
The study compared Capvaxive with PPSV23, a pneumococcal 23-valent polysaccharide vaccine, in children and adolescents aged 2 to 17 years who had already completed a primary pneumococcal vaccination series and had chronic conditions that placed them at higher risk for pneumococcal disease.
The trial evaluated the vaccine’s immune response and safety profile in this specific patient group.
Merck Highlights Commitment to Infectious Disease Prevention
Dr. Paula Annunziato, Senior Vice President of Infectious Diseases and Vaccines, Global Clinical Development at Merck Research Laboratories, said the approval demonstrates the company's commitment to addressing pneumococcal disease across different age groups.
She explained that while Capvaxive was originally developed for adults, the vaccine may also provide added protection for children and adolescents at increased risk when administered after completion of the standard pediatric vaccination schedule.
Coverage Against Disease-Causing Serotypes
Merck highlighted data from a 2025 study based on CDC surveillance information collected between 2015 and 2019.
The analysis included children younger than 18 years with at least one risk condition such as chronic heart disease, chronic lung disease, diabetes, or chronic kidney disease.
According to the study, Capvaxive covers serotypes responsible for approximately 79% of invasive pneumococcal disease cases within this high-risk group. Additionally, the 11 unique serotypes included in Capvaxive account for around 40% of invasive pneumococcal disease cases among these patients.
The company noted that these figures are based on epidemiological data and do not represent vaccine efficacy outcomes.
Important Safety Information
Capvaxive should not be administered to individuals with a history of severe allergic reactions, including anaphylaxis, to any component of the vaccine or to diphtheria toxoid.
The indication for preventing pneumonia caused by certain pneumococcal serotypes has been granted under the FDA’s accelerated approval pathway. Continued approval may depend on confirmation of clinical benefit through future studies.
Capvaxive’s Growing Role in Pneumococcal Disease Prevention
With this expanded approval, Capvaxive becomes an additional vaccination option for children and adolescents living with chronic health conditions that increase their risk of serious pneumococcal infections. The decision further broadens Merck’s vaccine portfolio while addressing an important unmet need in vulnerable pediatric populations.

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