FDA Approves Additional Indication for Capvaxive in Children Aged 2-17 at Increased Risk for Pneumococcal Disease
Key Takeaways
- Capvaxive uniquely adds eight adult-predominant invasive serotypes absent from other approved pneumococcal vaccines, positioning it to address serotype replacement gaps after routine pediatric PCV schedules.
- The pediatric indication is restricted to ages 2–17 with comorbidities (e.g., diabetes; chronic cardiac, renal, hepatic, or pulmonary disease) following a completed primary pneumococcal series.
FDA has expanded Capvaxive's indication to high-risk children and adolescents aged 2 through 17 who have completed a primary pneumococcal series, making it the only conjugate vaccine in the U.S. specifically studied and approved for this population.
FDA has approved an expanded indication for Merck's Capvaxive to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that increase their risk of pneumococcal disease.
The approval makes Capvaxive the only pneumococcal conjugate vaccine specifically indicated and studied in the United States for this patient population.
What is Capvaxive and why was it expanded to pediatric patients?
Capvaxive was originally developed for adults and was specifically designed to cover Streptococcus pneumoniae serotypes that are predominantly responsible for invasive pneumococcal disease in that population, including eight serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B, not found in other approved pneumococcal vaccines.1
The new pediatric approval extends its use into a narrower, high-risk subset of children and adolescents: those with chronic conditions such as diabetes, chronic heart disease, chronic kidney disease, chronic liver disease, and chronic lung 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 and an investigator in 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."
What did the Stride-13 trial show?
The approval is based on results from the Phase III Stride-13 trial, a randomized, double-blind, active comparator-controlled study that enrolled 874 participants aged 2 through 17 years with one or more prespecified risk conditions who had previously completed a primary pneumococcal vaccination series at least eight weeks prior to enrollment.2 Participants were randomized 3:2 to receive a single dose of Capvaxive (n=527) or the pneumococcal 23-valent polysaccharide vaccine PPSV23 (n=347).2
Capvaxive was noninferior to PPSV23 across the 12 serotypes shared between the two vaccines and elicited statistically significantly greater opsonophagocytic activity geometric mean titers compared with PPSV23 for the nine serotypes unique to Capvaxive.2 A post-hoc analysis also demonstrated noninferiority for serotype 15B, which is cross-reactive to the covered serotype 15C.
The safety profile was generally comparable to PPSV23. Solicited adverse reactions lasted a median of two days, with most lasting three days or fewer.1 The most commonly reported reactions in the 2-through-17 age group included injection-site pain (67.7%), injection-site erythema (24.3%), fatigue (20.1%), and injection-site swelling (18.8%).2
Serious adverse events within six months of vaccination occurred in 5.5% of Capvaxive recipients and 7.2% of PPSV23 recipients, with no notable patterns or imbalances between groups.2
"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 of infectious diseases and vaccines, global clinical development at 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."
Sources
- U.S. FDA Approves an Additional Indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) in Children and Adolescents Aged 2 through 17 at Increased Risk for Pneumococcal Disease Merck June 18, 2026
https://www.merck.com/news/u-s-fda-approves-an-additional-indication-for-capvaxive-pneumococcal-21-valent-conjugate-vaccine-in-children-and-adolescents-aged-2-through-17-at-increased-risk-for-pneumococcal-disease/ - A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (STRIDE-13) National Library of Medicine March 11, 2026
https://clinicaltrials.gov/study/NCT06177912?intr=v116&rank=1
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