MSD challenges Pfizer in pneumococcal vaccine market post-FDA approval

Merck & Co (MSD) has received approval from the US Food and Drug Administration (FDA) for its 21-valent pneumococcal vaccine, Capvaxive. This vaccine is intended to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. According to MSD, the strains included in Capvaxive were responsible for 84% of invasive pneumococcal disease cases in individuals aged 50 and over between 2018 and 2021. Although the vaccine is approved for adults aged 18 and above, MSD has tailored it specifically for those aged 50 and older. Capvaxive includes eight unique serotypes—15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B—that distinguish it from other available pneumococcal vaccines.

This new vaccine enters the market as a competitor to Pfizer's 20-valent vaccine, Prevnar 20, which was approved in 2021 for both children and adults. Currently, Prevnar 20 holds a dominant position in the adult pneumococcal vaccine market. However, MSD pointed out that the strains covered by Prevnar 20 account for only 52% of invasive pneumococcal disease in the same population, based on data from the US Centers for Disease Control and Prevention (CDC) for the years 2018-2021.

GlobalData's Pharma Intelligence Center forecasts that Capvaxive could generate $1.16 billion in revenue by 2030. Supporting the approval of Capvaxive are clinical data from the Phase III STRIDE-3 trial (NCT05425732), which compared the vaccine to Prevnar 20 in adults aged 18 and older who had no prior pneumococcal vaccination. The trial demonstrated that Capvaxive was non-inferior to Prevnar 20 in terms of immune response for the 10 serotypes common to both vaccines and superior in 10 of its 11 unique serotypes.

Pneumococcal disease, caused by the bacteria Streptococcus pneumoniae, includes illnesses such as pneumonia, meningitis, and bloodstream infections. There are approximately 100 different serotypes of pneumococcal bacteria, which affect adults differently than children. The CDC's Advisory Committee on Immunization Practices is expected to convene later this month on June 27 to discuss and make recommendations for the use of Capvaxive in adults.

Walter Orenstein, a member of MSD's scientific advisory committee, highlighted the importance of Capvaxive, stating, "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."