US FDA approves Merck pneumococcal vaccine for adults – 06/18/2024 at 00:49

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Merck MRK.N said on Monday that the U.S. Food and Drug Administration had approved its next-generation vaccine to protect adults against pneumococcal disease.

This disease can lead to infections in several parts of the body, including the lungs, where it can cause pneumonia. There are approximately 100 different strains of the bacteria that can cause these infections.

Merck’s vaccine, called Capvaxive, helped produce an immune response against all 21 serotypes, or variants of the bacteria, targeted by the vaccine in various adult populations in different studies.

The drugmaker said the bulk purchase price of the vaccine was $287 per dose, but that most people could get access without having to pay anything out of pocket if advisers to the Centers for Disease Control and Prevention (CDC) recommend the vaccine systematically.

The company anticipates the vaccine will be available in late summer, subject to the recommendation of CDC advisors.

CDC advisers are expected to discuss the vaccine at a meeting later this month.

Capvaxive is approved for adults ages 18 and older, according to the FDA letter.

Pneumococcal diseases are spread by direct contact with respiratory secretions such as saliva or mucus. Children under five and adults 65 and older are at increased risk of contracting the disease.

Merck currently has two approved pneumococcal vaccines: Vaxneuvance, which is given to people aged six weeks or older, and Pneumovax 23, intended for adults aged 50 and older as well as children aged two and older who are at increased risk to contract the disease.

Merck competes with Pfizer PFE.N in the U.S. pneumococcal vaccine market and hopes to gain a majority share with the launch of Capvaxive.

Pfizer’s vaccine, Prevnar 20, was approved in 2021 for use in adults aged 18 or older and protects against 20 serotypes. It is also authorized for infants aged six weeks to 17 years.

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