Merck announces EC approved Capvaxive pneumococcal vaccine

Merck (MRK), known as MSD outside of the United States and Canada, announced that the European Commission, or EC, has approved CAPVAXIVE, or Pneumococcal 21-valent Conjugate Vaccine, for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE is a pneumococcal vaccine specifically designed to help protect adults from the serotypes responsible for the majority of invasive pneumococcal disease, or IPD, cases. The EC approval of CAPVAXIVE is based on safety and immunogenicity data from the Phase 3 STRIDE clinical program. This decision authorizes the marketing of CAPVAXIVE in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. The timing for availability of CAPVAXIVE in individual countries will depend on multiple factors, including the completion of reimbursement procedures. CAPVAXIVE was approved in the U.S. in June 2024, in Canada in July 2024, and in Australia in January. European Union country-level data have demonstrated that the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20. CAPVAXIVE was approved by the EC based on data that included Phase 3 clinical studies designed to evaluate its safety and immunogenicity in a variety of adult populations.