Merck Gains FDA Nod for First Adult Pneumococcal Vaccine

The U.S. Food and Drug Administration (FDA) granted approval for Merck's new 21-valent pneumococcal conjugate vaccine, named Capvaxive, on Monday. This vaccine is intended for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults.

Capvaxive is engineered to target pneumococcal strains that are responsible for roughly 84% of invasive pneumococcal disease cases. The vaccine is unique in its inclusion of eight serotypes not covered by currently available pneumococcal vaccines. These eight serotypes are significant as they account for approximately 27% of IPD cases in adults aged 50 and older, and around 30% of cases in seniors 65 years and older.

The indication for pneumococcal pneumonia under Capvaxive was approved through the FDA’s accelerated pathway. This approval mechanism requires ongoing verification of clinical benefits through a confirmatory study for continued endorsement.

Walter Orenstein, a professor emeritus at Emory University and a member of Merck’s scientific advisory committee, highlighted the significance of Capvaxive in a statement. He emphasized that Capvaxive addresses the serotypes causing the majority of adult invasive pneumococcal disease, many of which are not included in other approved pneumococcal conjugate vaccines.

The FDA's approval of Capvaxive was supported by data from the Phase III STRIDE-3 study. This study demonstrated that Merck’s vaccine was non-inferior to an existing 20-valent comparator vaccine. Additionally, data from November 2023 indicated that Capvaxive elicited superior immune responses for 10 of the 11 serotypes not covered by the 20-valent comparator.

Safety and tolerability data from STRIDE-3 suggested that Capvaxive had an adverse event profile similar to that of the comparator vaccine. Further support for Capvaxive’s approval came from Phase III STRIDE-4 and STRIDE-6 studies, which evaluated the vaccine in both vaccine-naïve and vaccine-experienced adults.

With this new approval, Merck is set to challenge Pfizer in the pneumococcal vaccine market. Pfizer’s 20-valent vaccine, Prevnar 20, currently leads the market and was first approved in June 2021 for adults aged 18 and older against IPD and pneumonia. The FDA extended Prevnar 20's label in April 2023 to include infants and children aged six weeks to 17 years.

For Pfizer, the Prevnar vaccine line, which also includes Prevnar 13, has been a significant revenue driver. In the first quarter of 2024, Prevnar products saw a 7% year-over-year growth, primarily due to its pediatric indication. During this period, Prevnar vaccines generated $1.7 billion globally.

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