US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced the European Commission (EC) approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine). The vaccine is approved to prevent invasive disease and pneumonia caused by 21 different Streptococcus pneumoniae serotypes in adults: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.
Vaccine Background and Approval
Capvaxive is a pneumococcal vaccine specifically designed to help protect adults from the serotypes responsible for the majority of invasive pneumococcal disease (IPD) cases. It is already approved in the US, Canada, and Australia. The EC approval is based on the safety and immunogenicity data from the Phase III STRIDE study, which demonstrated the vaccine’s efficacy and safety profile.
Market Expansion
With this approval, Capvaxive can now be listed and distributed in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein, and Norway. This marks a significant step in expanding access to this important preventive measure against pneumococcal diseases in the European region.-Fineline Info & Tech
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