Merck, known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE? (Pneumococcal 21-valent Conjugate Vaccine) for: CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The U.S. Centers for Disease Control and Prevention?s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of CAPVAXIVE in adults. Based on CDC data from 2018-2021, the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine). In adults 50 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately 84% of IPD cases, compared to approximately 52% covered by PCV20.

In adults 65 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately 85% of IPD cases, compared to approximately 51% covered by PCV20. These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20.

CAPVAXIVE includes eight unique serotypes not covered by other currently approved pneumococcal vaccines; those serotypes were responsible for approximately 27% of IPD cases in adults 50 years of age and older and approximately 30% in adults 65 years of age and older, based on the same CDC data. Among the clinical data supporting the approval 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 approval is also supported by results from the Phase 3 STRIDE-5 (NCT05526716) and STRIDE-6 (NCT05420961) trials evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults (see ?Clinical Data Supporting FDA Approval,?

below, for additional details).