The U.S. Centers for Disease Control and Prevention (CDC) has endorsed the use of Merck's newly approved pneumococcal vaccine, Capvaxive, for adults. In an announcement on Friday, Merck shared that the CDC's Advisory Committee on Immunization Practices (ACIP) had unanimously voted to support the vaccine.
The ACIP's recommendation specifies that Capvaxive is suitable for adults aged 65 and older who have either not been vaccinated with a pneumococcal conjugate vaccine or have unknown vaccination histories. Additionally, the vaccine can be administered to adults aged 19 to 64 who have particular underlying medical conditions or other risk factors.
Furthermore, the ACIP has recommended Capvaxive for adults aged 19 and older who began their vaccination series with the 13-valent pneumococcal conjugate vaccine but have not yet completed the full set of recommended doses for the 23-valent polysaccharide pneumococcal vaccine. These recommendations are provisional and will be finalized once they receive approval from the CDC director and the Department of Health and Human Services.
Merck’s Chief Medical Officer, Eliav Barr, described Capvaxive as an “innovative approach” designed to protect against invasive pneumococcal disease (IPD) in adults. According to Barr, the vaccine aims to protect against the strains that cause the most severe diseases in adults aged 65 and older. Barr expressed optimism about the CDC's final, published guidelines following ACIP's endorsement, highlighting the recognition of the clinical benefits of Capvaxive for adults in the U.S.
The ACIP vote followed the U.S. Food and Drug Administration’s (FDA) earlier approval of Capvaxive this month for preventing IPD and pneumococcal pneumonia in adults. The FDA granted this approval under its accelerated pathway, meaning Merck will still need to confirm the vaccine’s clinical benefits in a follow-up trial.
Capvaxive stands out among current pneumococcal vaccines, including its main competitor, Pfizer's Prevnar 20. Capvaxive covers eight unique serotypes that account for about 27% of IPD cases in patients aged 50 and older and roughly 30% of cases in those aged 65 and older. This broader coverage gives Capvaxive a competitive advantage over Prevnar 20, which has dominated the pneumococcal vaccine market since its initial approval in June 2021 for adults 18 years and older. In April 2023, Prevnar 20’s use was also extended to children aged six weeks through 17 years.
Despite Capvaxive’s potential, Pfizer’s Prevnar 20 remains a strong competitor. The Prevnar family of vaccines generated $1.7 billion in worldwide revenue for Merck in the first quarter of 2024, reflecting its significant market presence.
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