(Reuters) – Merck said on Monday the U.S. Food and Drug Administration has approved its next-generation vaccine to protect adults against pneumococcal disease.
The disease can lead to infections in several parts of the body, including the lungs, where they can cause pneumonia. There are about 100 different strains of bacteria that can cause these infections.
Merck’s vaccine, branded Capvaxive, helped generate an immune response against all 21 serotypes or variants of the bacteria it targeted in different groups of adults in studies.
The drugmaker said the vaccine has a wholesale purchase price of $287 per dose, but most people would likely have access to it without any out-of-pocket costs if they receive regular advice from Centers for Disease Control and Prevention advisers.
The company expects the vaccine to be available by late summer, according to recommendations from CDC advisers.
CDC advisers are expected to discuss the vaccine at a meeting later this month.
According to the FDA letter, Capvaxiv is approved for adults 18 years of age and older.
Pneumococcal infection is spread by direct contact with respiratory secretions such as saliva or mucus. Children under five years of age and adults 65 years of age and older are at increased risk of contracting the disease.
Merck currently has two approved pneumococcal vaccines: Vaxneuvance, which is given to people over six weeks of age, and Pneumovax 23 for adults 50 years of age and older, and children two years of age and older, who are at higher risk for the disease.
Merck competes with Pfizer (NYSE:) in the US pneumococcal vaccine market and hopes to gain a majority share with the launch of Capvaxive.
Pfizer’s Prevnar 20 vaccine was approved in 2021 for use in adults 18 years and older and protects against 20 serotypes. It is also approved for use in children aged six weeks to 17 years.