Merck gets key CDC endorsement for pneumonia vaccine

Less than two weeks after receiving FDA approval for its 21-valent pneumococcal conjugate vaccine, Merck & Co. celebrated another significant milestone for its vaccine, Capvaxive. On Thursday, the CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended that all adults 65 years and older who have never previously received a pneumococcal conjugate vaccine should get the Capvaxive shot.

Additionally, ACIP advised that adults aged 19 to 64 with certain underlying medical conditions or other risk factors should receive Merck’s vaccine. This recommendation also extends to adults over 19 who started their pneumococcal vaccination series with Pfizer’s Prevnar 13 but have not completed all the recommended doses of Merck’s Pneumovax 23.

While this is an overall win for Merck, the company had been hoping for a broader recommendation that would include all adults aged 50 and older. Capvaxive was specifically designed to combat Streptococcus pneumoniae serotypes that are responsible for 84% of invasive pneumococcal disease (IPD) cases in adults over 50.

The committee’s endorsement positions Capvaxive to compete directly with Pfizer’s Prevnar brand, which achieved global sales of $6.4 billion last year. In 2022, ACIP had recommended Prevnar 20 for the same groups that Capvaxive is now targeted at: adults 65 and older, and adults aged 19 to 64 with certain underlying medical conditions or other risk factors. With this equal recommendation from the CDC, Merck aims to set itself apart by highlighting Capvaxive's broader serotype coverage.

Capvaxive protects against eight serotypes that account for about 27% of invasive pneumococcal disease cases in adults 50 and older, which are not covered by Prevnar 20. However, Pfizer’s vaccine also has the advantage of being approved for use in children. Last year, ACIP recommended Prevnar 20 as a routine vaccination for all children under two years of age, as well as for those aged 2 to 18 with certain underlying medical conditions that increase their risk for pneumococcal disease.

With these new recommendations, Merck is poised to make significant inroads in the pneumococcal vaccine market, challenging Pfizer’s long-standing dominance. The broader serotype coverage offered by Capvaxive could be a key differentiator in winning over healthcare providers and patients alike.