FDA Approves Capvaxive Expanded Indication to Include Children, Adolescents at Increased Risk for Pneumococcal Disease

The FDA approved an expanded indication for pneumococcal 21-valent conjugate vaccine (PCV21, Capvaxive; Merck), to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have at least 1 chronic medical condition 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.¹

PCV21 is a single-dose vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults aged 18 years and older and for the prevention of invasive disease in children and adolescents aged 2 through 17 years who have 1 or more chronic medical conditions that put them at an increased risk of pneumococcal disease. PCV21was specifically designed to help address the Streptococcus pneumoniae serotypes predominantly responsible for invasive pneumococcal disease (IPD) in adults, including 8 unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B compared to other approved pneumococcal vaccines.¹

Clinical Data Supporting the New Indication

The expanded indication is supported by clinical trial data from STRIDE-13 (NCT06177912)², a randomized, double-blind, active comparator-controlled phase 3 study that evaluated 874 individuals aged 2 through 17 years with 1 or more prespecified medical conditions known to increase the risk of pneumococcal disease, including diabetes, chronic heart disease, chronic kidney disease, chronic liver disease, chronic lung disease. All participants completed a primary pneumococcal vaccination regimen at least 8 weeks prior to enrollment and were randomly assigned in a 3:2 ratio to receive a single dose of either PCV21 (n = 527) or PPSV23 (n = 347).^1-3

According to the study findings, PCV21 was noninferior to PPSV23 for the 12 serotypes shared between the vaccines and produced statistically significantly greater opsonophagocytic activity geometric mean titers for the 9 serotypes unique to PCV21. Of note, PCV21 elicited immune responses to serotype 15B, which is cross-reactive with serotype 15C. A post hoc analysis using the same prespecified noninferiority criterion applied to the shared serotypes found that PCV21 was also noninferior to PPSV23 for serotype 15B.

The safety profile of PCV21 was generally comparable to that of PPSV23. Adverse events (AEs) following PCV21 administration lasted a median of 2 days, most of which resolved within 3 days or less. Within 6 months of vaccination, approximately 5.5% (n = 29) of participants who received PCV21 and 7.2% (n = 25) of those who received PPSV23 reported 1 or more serious AEs, and there were no notable patterns or imbalances in serious AEs observed between the 2 treatment groups. One participant (0.2%) in the PCV21 group experienced a serious AE—grade 2 syncope requiring hospitalization that occurred about 3 minutes after vaccination—that was related to vaccination.^1,3

What Should Pharmacists Know?

According to the news release from Merck, the expanded indication for Capvaxive complements existing primary pediatric pneumococcal vaccination series for children and adolescents who are at increased risk for pneumococcal disease.¹

The FDA's expanded indication for PCV21 pharmacists with a new vaccination option for children and adolescents aged 2 through 17 years with certain chronic medical conditions who remain at increased risk for IPD despite completing a routine pediatric pneumococcal vaccination series. As immunization providers, pharmacists can play an important role in identifying eligible patients during medication reviews, chronic disease management visits, and immunization assessments. Reviewing vaccination histories, screening for qualifying chronic medical conditions, and educating caregivers about updated vaccine recommendations may help improve vaccination rates among children and adolescents at increased risk for pneumococcal disease.

Pharmacists should also continue monitoring recommendations from medical organizations as clinical practice and vaccine scheduling recommendations may evolve following the FDA's expanded approval.

“While [PCV21] 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,” Paula Annunziato, MD, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said in the news release. “The approval of [PCV21] 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 [our] longstanding commitment to public health and infectious diseases.”¹

REFERENCES

1. 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. News release. June 18, 2026. Accessed 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/

2. A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (STRIDE-13). ClincialTrials.gov identifier: NCT06177912. Updated March 11, 2026. Accessed June 18, 2026. https://clinicaltrials.gov/study/NCT06177912

3. CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) Demonstrates Positive Immune Responses in Children and Adolescents at Increased Risk of Pneumococcal Disease. Merck. News release. September 11, 2025. Accessed June 18, 2026. https://www.merck.com/news/capvaxive-pneumococcal-21-valent-conjugate-vaccine-demonstrates-positive-immune-responses-in-children-and-adolescents-at-increased-risk-of-pneumococcal-disease/