CDC backs Merck’s Capvaxive, tees up pneumococcal competition with Pfizer

CDC backs Merck’s Capvaxive, tees up pneumococcal competition with Pfizer

Published: Jul 01, 2024

By Tristan Manalac

BioSpace

The U.S. Centers for Disease Control and Prevention has backed the use of Merck’s recently approved pneumococcal vaccine Capvaxive for use in adults, according to the pharma’s announcement on Friday.

In a unanimous vote, the CDC’s Advisory Committee on Immunization Practices (ACIP) endorsed the use of Merck’s 21-valent shot for adults 65 years and older who have not yet been immunized with a pneumococcal conjugate vaccine, or whose vaccination histories are unknown. Capvaxive can also be used in adults 19 through 64 years of age with specific underlying conditions or other risk factors.

The ACIP has also recommended the use of Capvaxive in adults 19 years and older who have started their vaccination series with the 13-valent pneumococcal conjugate vaccine but haven’t yet completed all the recommended doses for the 23-valent polysaccharide pneumococcal vaccine.

The ACIP’s recommendations will remain provisional and will become official after being reviewed and authorized by the director of the CDC and the Department of Health and Human Services.

Merck CMO Eliav Barr in a statement called Capvaxive an “innovative approach” to induce protection against invasive pneumococcal disease (IPD) in adults. The vaccine “is specifically designed to help protect against the strains that cause the majority of severe disease in adults 65 years of age and older,” according to Barr.

The ACIP’s endorsement “recognizes the clinical profile of Capvaxive for adults in the U.S.,” Barr said. “We look forward to the CDC’s final, published recommendations.”

Friday’s ACIP vote comes after the FDA earlier this month cleared Capvaxive for the prevention of IPD and pneumococcal pneumonia in adults. The regulator granted the approval under its accelerated pathway, with Merck still needing to validate the vaccine’s clinical benefits in a confirmatory trial.

Unlike the current commercially available pneumococcal vaccines—including its top competitor, Pfizer’s Prevnar 20—Capvaxive covers eight unique serotypes that together account for around 27% of IPD cases in patients 50 years and older, and approximately 30% of cases in seniors 65 years and older.

This differentiated coverage profile could give Capvaxive a competitive edge over Prevnar 20, which otherwise currently dominates the pneumococcal vaccine space. The 20-valent vaccine was first approved in June 2021 for use in adults 18 years and older and in April 2023 was expanded to immunize children aged six weeks through 17 years.

Prevnar 20 currently leads Merck’s Prevnar family of vaccines, which in the first quarter of 2024 brought in a total of $1.7 billion in worldwide revenue.

Source: BioSpace