Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the European Commission (EC) has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active immunization against invasive disease and pneumonia caused by 21 Streptococcus pneumoniae serotypes. This vaccine is designed specifically to protect adults and is based on safety and immunogenicity data from the Phase 3 STRIDE clinical program.
Expanding Access Across Europe
As per the Merck press release, this approval allows CAPVAXIVE to be marketed in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein, and Norway. Availability in each country will depend on reimbursement procedures. The vaccine was previously approved in the U.S. in June 2024, in Canada in July 2024, and in Australia in January 2025.
Expert Insights on the Approval
Dr. Lina Pérez Breva from Fisabio – Public Health in Valencia, Spain, emphasized the importance of CAPVAXIVE in protecting high-risk adults, particularly those aged 65 and older or those with compromised immune systems. Dr. Paula Annunziato, Senior Vice President of Infectious Diseases and Vaccines at Merck Research Laboratories, highlighted how CAPVAXIVE targets serotypes responsible for most adult invasive pneumococcal disease cases, reinforcing its importance in adult immunization programs.
Superior Coverage Compared to PCV20
European Union data demonstrate that CAPVAXIVE covers more serotypes responsible for invasive pneumococcal disease (IPD) in adults compared to PCV20. In Germany, CAPVAXIVE provides approximately 84% coverage for individuals aged 60 and older, while PCV20 covers around 58%. In France, CAPVAXIVE covers approximately 85% of cases in adults over 65, compared to 63% with PCV20. Similarly, in Italy, CAPVAXIVE covers around 77% of cases, whereas PCV20 covers 64%. In Spain, CAPVAXIVE offers 82% coverage compared to 62% with PCV20.
Clinical Trials Supporting Approval
The EC approval is based on multiple Phase 3 trials under the STRIDE clinical program:
- STRIDE-3: Demonstrated non-inferiority of CAPVAXIVE compared to PCV20 for shared serotypes and superior immune responses for 10 additional serotypes.
- STRIDE-10: Showed CAPVAXIVE’s effectiveness compared to PPSV23, with superior responses for nine unique serotypes.
- STRIDE-4: Confirmed consistency across different CAPVAXIVE manufacturing lots.
- STRIDE-5: Proved CAPVAXIVE’s efficacy when administered alongside the quadrivalent influenza vaccine (QIV).
- STRIDE-6: Evaluated CAPVAXIVE’s immune responses in adults previously vaccinated with other pneumococcal vaccines.
- STRIDE-7: Assessed CAPVAXIVE’s effectiveness in individuals living with HIV.
Conclusion
With this approval, Merck strengthens its commitment to combating pneumococcal disease in adults. CAPVAXIVE’s broad coverage and demonstrated immunogenicity position it as a crucial tool in preventing invasive pneumococcal disease across Europe and beyond.