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21‑Valent Pneumococcal Conjugate Vaccine V116 (CAPVAXIVE®): Pediatric First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.
Paediatric Drugs
|July 27, 2026
Summary
The 21-valent pneumococcal conjugate vaccine (PCV) V116 is now approved for adults and children at high risk. This vaccine targets additional Streptococcus pneumoniae serotypes to prevent pneumonia and invasive disease.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- The 21-valent pneumococcal conjugate vaccine (PCV) V116 (CAPVAXIVE®) targets Streptococcus pneumoniae serotypes not covered by existing vaccines.
- V116 was initially approved for adults in the USA (June 2024) and subsequently in the EU and other countries to address residual pneumococcal disease.
Purpose of the Study:
- To explore the potential of V116 in complementing pediatric pneumococcal vaccination regimens.
- To summarize the development milestones of V116 leading to its first pediatric approvals.
Main Methods:
- Phase III clinical evaluation in children and adolescents at increased risk for pneumococcal disease.
- Review of development and regulatory approval processes for V116 in pediatric populations.
Main Results:
- V116 received its first pediatric approval in the EU (March 2026) for children and adolescents (2 to <18 years) completing primary vaccination.
- US approval was extended in June 2026 to include at-risk individuals aged 2-17 years.
Conclusions:
- V116 represents a significant advancement in preventing pneumococcal pneumonia and invasive disease in both adult and pediatric populations.
- The vaccine's unique serotype coverage offers expanded protection, particularly for at-risk children and adolescents.
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