21‑Valent Pneumococcal Conjugate Vaccine V116 (CAPVAXIVE^®): Pediatric First Approval

The 21‑valent pneumococcal conjugate vaccine (PCV) V116 (CAPVAXIVE^®), developed by Merck & Co., has been approved in the USA since June 2024 for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae in adults, with subsequent approvals in adults in the EU and a range of other countries. With the inclusion of eight S. pneumoniae serotypes that are not included in other currently licensed pneumococcal vaccines, V116 was designed to target residual pneumococcal disease in adults. Noting that some of the unique serotypes in V116 are responsible for significant pneumococcal disease in children and adolescents, the potential value of V116 in also complementing existing pediatric pneumococcal vaccination regimens has been explored. Supported by phase III clinical evaluation in children and adolescents with an increased risk of pneumococcal disease, in March 2026, V116 received its first pediatric approval, in the EU, for active immunization for the prevention of invasive disease and pneumonia caused by S. pneumoniae in children and adolescents 2 to < 18 years of age who previously completed a primary pediatric pneumococcal vaccination regimen. Subsequently, in June 2026, the US approval for V116 was extended to include use in individuals 2-17 years of age who are at increased risk for pneumococcal disease. This article summarizes the milestones in the development of V116 leading to these first pediatric approvals for active immunization for the prevention of invasive disease and pneumonia caused by S. pneumoniae.