The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Merck’s CAPVAXIVE, a 21-valent pneumococcal conjugate vaccine, for adults aged 18 and older. The vaccine aims to prevent invasive pneumococcal disease and pneumonia caused by •Streptococcus pneumoniae•. A final decision from the European Commission is anticipated by the second quarter of 2025.
This positive CHMP opinion is crucial for European public health, as invasive pneumococcal disease and pneumonia pose significant threats, leading to hospitalization, organ damage, and even death. CAPVAXIVE offers broader serotype coverage compared to existing vaccines, potentially providing enhanced protection against prevalent strains in several European countries. This expanded coverage could translate to a more impactful reduction in pneumococcal disease burden compared to the currently available 20-valent conjugate vaccine.
Data from the Phase 3 STRIDE clinical trials, comparing CAPVAXIVE to the 20-valent vaccine in adults, supported the CHMP’s recommendation. Specifically, country-specific data from Germany, France, Italy, and Spain indicates that CAPVAXIVE covers a greater percentage of serotypes responsible for invasive pneumococcal disease in adults compared to the existing 20-valent option. This recommendation follows approvals in the U.S., Canada, and Australia, with ongoing reviews in Japan and other regions.
The potential European approval of CAPVAXIVE represents a significant advancement in adult pneumococcal disease prevention. Broader serotype coverage addresses a crucial need for enhanced protection, potentially reducing the incidence of severe complications and mortality. This positive momentum positions CAPVAXIVE as a key player in the global fight against pneumococcal disease, promising improved public health outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
