US FDA approves Merck's pneumococcal vaccine for adults
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[June 18, 2024]
(Reuters) -Merck said on Monday the U.S. Food and Drug
Administration has approved its next-generation vaccine to protect
adults against the pneumococcal disease.
The disease can lead to infections in several parts of the body
including the lungs, where they can cause pneumonia. There are around
100 different strains of the bacteria that can cause those infections.
Merck's vaccine, branded Capvaxive, helped produce an immune response
against all 21 serotypes, or variations of the bacteria, that the shot
targeted in a variety of adult populations across studies.
The drugmaker said the vaccine has a wholesale acquisition price of $287
per dose, but most individuals will likely have access to it at no
out-of-pocket cost if it gets a routine recommendation from the Centers
for Disease Control and Prevention's advisers.
The company expects the vaccine to be available by late-summer, subject
to CDC advisers' recommendation.
The advisers to the CDC are expected to discuss the vaccine in a meeting
later this month.
Capvaxive is approved for adults 18 years of age and older, according to
the FDA's letter.
Pneumococcal disease spreads through direct contact with respiratory
secretions such as saliva or mucus. Children younger than five-years old
and adults 65 years and above are at an increased risk of contracting
the disease.
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Signage is seen at the Merck & Co. headquarters in Kenilworth, New
Jersey, U.S., November 13, 2021. REUTERS/Andrew Kelly/File Photo
Merck currently has two approved
pneumococcal shots — Vaxneuvance that is given to six weeks or older
individuals 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.
Merck competes with Pfizer in the U.S. market for pneumococcal
vaccines and hopes to gain a majority share with the launch of
Capvaxive.
Pfizer's shot, Prevnar 20, was approved in 2021 for use in adults
aged 18 years or older and protects against 20 serotypes. It is also
approved for use in six-weeks old infants to 17-year olds.
(Reporting by Bhanvi Satija, Sneha S K and Puyaan Singh in Bengaluru;
Editing by Shailesh Kuber and Shilpi Majumdar)
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