Merck (NYSE: MRK) has received European Commission (EC) approval for CAPVAXIVE®, a 21-valent pneumococcal conjugate vaccine for adults aged 18 and older. The vaccine is designed to prevent invasive pneumococcal disease and pneumonia caused by 21 specific Streptococcus pneumoniae serotypes.
The approval, based on the Phase 3 STRIDE clinical program, covers all 27 EU member states, Iceland, Liechtenstein, and Norway. This marks CAPVAXIVE's fourth regulatory approval, following authorizations in the U.S. (June 2024), Canada (July 2024), and Australia (January 2025).
Clinical data demonstrated that CAPVAXIVE was non-inferior to existing vaccines (PCV20 and PPSV23) for shared serotypes and showed superiority for unique serotypes. The vaccine exhibited comparable safety profiles to other pneumococcal vaccines across multiple clinical trials, including studies with immunocompromised patients and those receiving concurrent influenza vaccination.
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