Merck’s Capvaxive Seeks to Become the Primary Shot for Pneumococcal Disease Prevention

1. Capvaxive covers roughly 84% of serotypes responsible for pneumococcal disease in adults 50 years and older.
2. Capvaxive is non-inferior to Prevnar 20 for the 10 serotypes they cover and shares a similar safety profile.

The Latest

The FDA has approved Merck’s Capvaxive vaccine in the treatment of pneumococcal disease making it the world’s first pneumococcal disease designed for adults. Merck’s four phase 3 trials showed Capvaxive non-inferiority in the 10 serotypes common to both Prevnar and Capvaxive and superiority in 10 of its 11 unique serotypes. While the approval of Capvaxive applies to individuals 18 years of age and up, it is specifically designed for patients aged 50 and up. In comparison, Prevnar 20 can be used for children and adults 65 years and older. With more than 150,000 adults hospitalized in the US with pneumococcal disease, Capvaxive presents an important opportunity to provide protection and prevention against pneumococcal disease as well as other serious complications such as bacteremia and pneumococcal meningitis.

Physician’s Perspective

Pneumococcal disease is caused by Streptococcus pneumoniae and affects young children and the elderly the most. Pneumococci are transmitted by direct contact through respiratory secretions. In adults 50 years and older, Capvaixve could cover roughly 84% of invasive pneumococcal disease cases compared to only 52% covered by Prevnar 20. For physicians, this would mean there could potentially be a more efficacious vaccine that can be offered to adult patients looking for prevention of pneumococcal disease. The most reported side effects of Capvaxive included injection-site pain, fatigue, headache, and myalgia.

Molecular Target of Therapy

While there are about 90 distinct pneumococcal serotypes that have been identified, a small number of these serotypes account for most of the pneumococcal disease found in infants and adults. Capvaxive is a conjugate vaccine that contains purified capsular polysaccharides of pneumococcal serotypes conjugated to a carrier protein. When the vaccine is administered, an antigen-presenting cell will take up the vaccine and display it on its surface as an antigen. Immune helper cells will be able to identify the antigen and trigger an immune response. In doing so, if the vaccinated individual is infected in the future, the immune system will be able to mount a better response. Capvaxive will offer active immunization prevention for Streptococcus pneumonia serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B.

Company History

Merck is a large American-based company with a history of developing medications, vaccines, and animal health products. Some of the most well-known Merck products include Januvia, an anti-diabetic medication, and Gardasil, an HPV vaccine. Merck continues to be active in the development of a variety of different therapeutic areas including monoclonal antibodies for treatments in oncology, respiratory disease, and cardiovascular disease.

Further reading: https://www.merck.com/news/u-s-fda-approves-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-prevention-of-invasive-pneumococcal-disease-and-pneumococcal-pneumonia-in-adults/