At its March 2026 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending the expanded use of Capvaxive (pneumococcal 21-valent conjugate vaccine, Merck Sharp & Dohme B.V.) to include children and adolescents aged 2 to less than 18 years who have previously completed a primary pediatric pneumococcal vaccination regimen. 

Capvaxive is already approved for active immunization against invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years or older.

Broadening Pediatric Protection 

Addressing pneumococcal disease remains a global priority; the condition can lead to severe invasive outcomes such as septicemia and meningitis. According to the US Centers for Disease Control and Prevention, S pneumoniae remains a leading cause of serious illness and death in children younger than 5 years worldwide.

This 21-valent vaccine contains capsular polysaccharides from 21 S pneumoniae serotypes conjugated to a carrier protein to enhance immune recognition. It is administered as a single intramuscular injection, is prescription only, and should be used in accordance with official recommendations.

What Evidence Shows 

The recommendation is supported by data from the phase 3 STRIDE-13 trial involving 882 children and adolescents. Participants, who were at increased risk for pneumococcal disease due to underlying medical conditions, received either a single dose of Capvaxive or the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in a 3:2 ratio.

Capvaxive produced immune responses against all 21 included serotypes. The vaccine was comparable to PPSV23 for the 12 shared serotypes and demonstrated superior responses for the nine serotypes unique to Capvaxive.

Safety Considerations 

Common side effects affecting more than 1 in 10 recipients include injection site pain, fatigue, headache, and myalgia. Most reactions are mild to moderate and typically resolve within 3 days post-vaccination.

Detailed recommendations will be published in the updated Summary of Product Characteristics following the final decision by the European Commission.