Merck's CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), marking a significant step toward its approval in the European Union. The recommendation supports the use of CAPVAXIVE for active immunization in adults aged 18 and older for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae. The European Commission is expected to review the CHMP’s recommendation, with a final decision anticipated in the second quarter of 2025.
Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, emphasized the importance of this decision, stating, "Invasive pneumococcal disease and pneumococcal pneumonia remain critical public health challenges worldwide...We are pleased with the CHMP recommendation and look forward to the European Commission's decision."
Clinical Data and Trial Results
The CHMP's positive opinion is backed by data from several Phase 3 STRIDE trials. Notably, the STRIDE-3 trial (NCT05425732) evaluated CAPVAXIVE against PCV20 (pneumococcal 20-valent conjugate vaccine) in adults aged 18 and older who had not previously received a pneumococcal vaccine. Additional support comes from the STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037), and STRIDE-10 (NCT05569954) trials, which assessed CAPVAXIVE in both vaccine-naïve and vaccine-experienced adult populations.
Heather Platt, MD, section head for respiratory vaccines at Merck, noted that the serotypes in Capvaxive are responsible for approximately 85% of invasive pneumococcal disease in adults in the U.S., and approximately the same amount globally. In key European markets, Capvaxive covers:
- Approximately 84% of disease in adults aged 60 years and older in Germany.
- Approximately 85% in adults aged 65 years and older in France.
- Approximately 77% of disease in Italy.
- Approximately 82% of disease in Spain.
CAPVAXIVE's Composition and Targeted Protection
CAPVAXIVE is a 21-valent pneumococcal conjugate vaccine specifically designed to protect adults against Streptococcus pneumoniae serotypes that are the primary cause of invasive pneumococcal disease (IPD). This includes eight unique serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B) not covered by other pneumococcal vaccines. The vaccine is administered as a single dose.
Global Approvals and Ongoing Reviews
If approved in the EU, this would be the fourth authorization for CAPVAXIVE. It was first approved in the U.S. in June 2024, followed by Canada in July 2024, and Australia in January 2025. The vaccine is also currently under review in Japan, with other regulatory filings underway worldwide.
Pneumococcal Disease and Public Health Impact
Pneumococcal disease, caused by the bacterium Streptococcus pneumoniae, presents in various forms, including non-invasive pneumonia and invasive illnesses like bacteremia and meningitis. Pneumococcal pneumonia is the most common clinical presentation in adults. CAPVAXIVE aims to reduce the burden of this disease, which can lead to hospitalization, organ damage, and even death.
