Capvaxive is approved for both the prevention of invasive pneumococcal disease and pneumococcal pneumonia. Credit: Sonia Bonet via Shutterstock.

Merck & Co (MSD) has won US Food and Drug Administration (FDA) approval for its 21-valent pneumococcal vaccine, Capvaxive, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia.  

According to MSD, the strains covered by Capvaxive were responsible for 84% of invasive pneumococcal disease in patients 50 years and older between 2018 and 2021. Though the approval is for ages 18 and above, the pharma giant has adapted the vaccine specifically for adults aged 50 and older. This includes the eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. 

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MSD’s 21-valent pneumococcal vaccine introduces a new rival to Pfizer’s 20-valent product Prevnar 20 (20-valent Pneumococcal Conjugate Vaccine), which was approved in 2021 for both children and adults. Prevnar 20 currently dominates the pneumococcal vaccine market for adults, however, MSD stated that the strains covered by the Prevnar 20 vaccine are responsible for only 52% of invasive pneumococcal disease in the same population, as per US Centers for Disease Control and Prevention (CDC) data from 2018-2021. 

According to a GlobalData’s Pharma Intelligence Center, Capvaxive is forecast to generate $1.16bn in 2030. 

GlobalData is the parent company of Pharmaceutical Technology. 

Among the clinical data supporting the approval are results from the Phase III STRIDE-3 trial (NCT05425732), which compared Capvaxive to Prevnar 20 in adults aged 18 and older who had not previously received a pneumococcal vaccine. When comparing immune responses, the study showed Capvaxive was non-inferior in the 10 serotypes common to both vaccines and superior in 10 of its 11 unique serotypes. 

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Pneumococcal disease, caused by the bacteria Streptococcus pneumoniae, encompasses illnesses such as pneumonia, meningitis, and bloodstream infections. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. 

The CDC Advisory Committee on Immunization Practices is expected to meet later this month on 27 June, to discuss and make recommendations for the use of Capvaxive in adults. 

Walter Orenstein, a member of MSD’s scientific advisory committee said: “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.”