FDA Approves Merck's New Pneumococcal Vaccine Capvaxive for Adults

• The FDA has approved Merck's new Capvaxive vaccine for adults, designed to protect against 21 strains of pneumococcal disease.
• The vaccine is expected to enter the market by late summer, pending a review and recommendation from the CDC's Advisory Committee on Immunization Practices.

On June 17, American biopharmaceutical healthcare company Merck announced that the U.S. Food and Drug Administration (FDA) had approved their new vaccine to protect adults from pneumococcal disease. 

Complications from invasive pneumococcal disease can result in hospitalization, organ damage, and death. Many adult cases are caused by strains not covered by existing pneumococcal vaccines. Around 100 different bacteria or strains can cause this disease, but not all of these strains are known. 

During studies, Merck's Capvaxive vaccine generated an immune response against all 21 variations of the bacteria it targeted in adult populations. 

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is to meet later this month to review and advise on using Capvaxive in adults.

At present, Merck has two officially approved vaccines for pneumococcal disease. Vaxneuvance is approved for individuals aged six weeks and older, while Pneumovax 23 is given every five years to people aged 50 and older, and to children over two years who are at higher risk of the disease.

However, Capvaxive covers eight unique serotypes not included in other approved pneumococcal vaccines. These serotypes account for about 27% of invasive pneumococcal disease (IPD) cases in adults aged 50 and older, and 30% in those aged 65 and older, according to CDC data.

Pfizer, which competes with Merck in the U.S. pneumococcal vaccine market, offers Prevnar 20, approved in 2021 for individuals aged 18 and older, covering 20 different strains. This vaccine is also available for children from six weeks to 17 years old. Merck aims to capture a more significant part of the market by providing Capvaxive.

Edited by Harshajit Sarmah