The U.S. Food and Drug Administration has approved Merck's vaccine, Capvaxive, to protect adults against pneumococcal disease, which can lead to infections in various parts of the body, including the lungs, causing pneumonia. The disease is caused by approximately 100 different strains of bacteria and spreads through direct contact with respiratory secretions.
Merck's vaccine demonstrated an immune response against all 21 targeted serotypes across adult populations in clinical studies. The wholesale acquisition price of Capvaxive is set at $287 per dose, and the vaccine's accessibility and out-of-pocket costs for individuals will depend on recommendations from the Centers for Disease Control and Prevention's (CDC) advisers. The vaccine's availability is expected by late summer, subject to the CDC advisers' recommendation, which will be discussed in a meeting later this month.
Capvaxive is approved for adults 18 years of age and older, according to the U.S. Food and Drug Administration (FDA)'s letter. Children under five years old and adults 65 years and above are at an increased risk of contracting pneumococcal disease. Merck has two other approved pneumococcal vaccines: Vaxneuvance for individuals six weeks or older and Pneumovax 23 for adults 50 years and older, as well as two-year-olds and above who are at an increased risk of the disease.
In the U.S. market for pneumococcal vaccines, Merck competes with Pfizer, which has an approved vaccine called Prevnar 20 that protects against 20 serotypes and is approved for use in adults aged 18 years or older and infants from six weeks old to 17-year-olds.