Research-intensive biopharmaceutical company Merck (NYSE: MRK), known as MSD outside the US and Canada, announced on Wednesday that it has secured European Commission (EC) approval for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active immunisation against invasive pneumococcal disease (IPD) and pneumonia in adults aged 18 and older. The approval is based on data from the Phase 3 STRIDE clinical program, assessing safety and immunogenicity.

Authorisation extends CAPVAXIVE's marketing across all 27 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. Rollout in individual countries will depend on reimbursement procedures. Previous approvals include the US in June 2024, Canada in July 2024 and Australia in January 2025.

EC approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in January 2025. CAPVAXIVE demonstrated strong immunogenicity compared to PCV20 and PPSV23 in pivotal Phase 3 trials, showing superior responses for additional serotypes not covered by competing vaccines.

CAPVAXIVE is designed to protect against serotypes responsible for the majority of IPD cases in adults. Merck continues to expand its global vaccine portfolio, reinforcing its position in the pneumococcal vaccine market.