Merck’s Capvaxive pneumococcal vaccine approved by FDA

USA—Merck & Co. (MSD) has achieved a milestone with the approval of its 21-valent pneumococcal vaccine, Capvaxive, by the U.S. Food and Drug Administration (FDA). 

This approval endorses the vaccine’s efficacy in preventing invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 and older, potentially leading to a significant impact on healthcare.

The approval is a significant milestone for Merck, as Capvaxive is specifically designed to target the serotypes responsible for most invasive pneumococcal disease cases in adults. 

According to Merck, the strains covered by Capvaxive caused 84% of invasive pneumococcal disease in patients 50 years and older between 2018 and 2021.

Capvaxive’s approval introduces a new rival to Pfizer’s 20-valent pneumococcal vaccine, Prevnar 20, which currently dominates the adult pneumococcal vaccine market.

 However, Merck stated that the strains covered by Prevnar 20 are responsible for only 52% of invasive pneumococcal disease in the same population, based on data from the U.S. Centers for Disease Control and Prevention (CDC) from 2018 to 2021.

“Capvaxive is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia,” said Dr. Walter Orenstein, a member of Merck’s Scientific Advisory Committee and professor emeritus at Emory University.

The FDA approval of Capvaxive is based on robust scientific evidence from the Phase III STRIDE-3 trial. 

This trial, which compared Capvaxive to Prevnar 20 in adults aged 18 and older who had not previously received a pneumococcal vaccine, demonstrated the vaccine’s non-inferiority to Prevnar 20 in the 10 serotypes common to both vaccines and its superiority in 10 of its 11 unique serotypes.

Merck expects to make Capvaxive available as soon as late July, pending recommendations from the CDC’s Advisory Committee on Immunization Practices. 

The committee is scheduled to meet on June 27 to discuss the vaccine’s use in adults.

According to GlobalData’s Pharma Intelligence Center report, Capvaxive is forecast to generate US$1.16 billion in sales by 2030 as Merck competes with Pfizer for a larger share of the pneumococcal vaccine market.

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