June 18, 2024 – The U.S. Food and Drug Administration (FDA) has approved Merck & Co Inc’s latest pneumococcal vaccine, branded Capvaxive, designed to protect adults against pneumococcal disease, the company announced on Monday.
Pneumococcal disease can cause infections in various parts of the body, including the lungs, leading to pneumonia. There are approximately 100 different strains of the bacteria responsible for these infections. Capvaxive has shown effectiveness in producing an immune response against all 21 serotypes targeted by the vaccine in a variety of adult populations across multiple studies.
The vaccine will be available at a wholesale acquisition price of $287 per dose. However, most individuals are expected to have access to it at no out-of-pocket cost if it receives a routine recommendation from the Centers for Disease Control and Prevention’s (CDC) advisers. The CDC advisers are set to discuss Capvaxive in an upcoming meeting later this month, and Merck anticipates the vaccine will be available by late summer, pending their recommendation.
Capvaxive is approved for adults aged 18 and older, as noted in the FDA’s approval letter. Pneumococcal disease spreads through direct contact with respiratory secretions like saliva or mucus. Individuals at higher risk include children under five and adults aged 65 and above.
Merck’s current pneumococcal vaccines include Vaxneuvance, approved for individuals aged six weeks and older, and Pneumovax 23, approved for adults aged 50 and older as well as children aged two and above who are at increased risk.
Merck competes with Pfizer Inc in the U.S. pneumococcal vaccine market. Pfizer’s vaccine, Prevnar 20, was approved in 2021 for adults aged 18 and older and covers 20 serotypes. Prevnar 20 is also approved for infants from six weeks old to 17 years old. Merck hopes to capture a majority market share with the launch of Capvaxive.
