Merck gets positive EU CHMP opinion for Pneumococcal vaccination in adults

CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. Based on country-level data from the following four EU countries, the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine):

Data were included for select countries based on EU membership, population size and the most recent year reported. These values are based on country-level epidemiologic data and regional variations may exist; these values do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20.

Among the clinical data supporting the recommendation are results from the pivotal Phase 3 STRIDE-3 trial (NCT05425732), which evaluated CAPVAXIVE compared to PCV20 in adults 18 years of age and older who had not previously received a pneumococcal vaccine. The recommendation is also supported by results from the Phase 3 STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037) and STRIDE-10 (NCT05569954) trials, evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults.

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.