Merck’s capvaxive receives positive EU CHMP opinion for pneumococcal vaccine

Merck (MRK) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, recommended the approval of capvaxive for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP’s recommendation will now be reviewed by the European Commission, or EC, for marketing authorization in the European Union – EU -, Iceland, Liechtenstein and Norway, and a final decision is expected by Q2. Capvaxive is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease cases. If approved in the EU, it would mark the fourth authorization of capvaxive for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. Capvaxive was first approved in the U.S. in June 2024, in Canada in July 2024, and in Australia in January 2025. In addition, capvaxive is currently under review in Japan, and other worldwide regulatory filings are underway.