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- WASHINGTON (Reuters) - A
vaccine against pneumococcus, a common bacterium that is a major cause
of serious infections such as meningitis in young children, won approval
from federal health officials Thursday.
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- The Food and Drug Administration said it cleared Prevnar,
made by American Home Products Corp, for preventing certain pneumococcal
infections in infants and toddlers.
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- Pneumococcal infections kill more than a million children
worldwide every year and are growing resistant to antibiotics.
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- ``For the first time, we have a highly effective way
to prevent a major cause of meningitis and serious blood infections in
the most susceptible children -- those under two years of age,'' FDA Commissioner
Jane Henney said in a statement.
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- Prevnar, which analysts expect to be a major new product
for AHP, will be available within the next two weeks, a company spokeswoman
said.
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- The vaccine was approved for preventing invasive pneumococcal
disease, in which bacteria have spread to the bloodstream, causing bacteremia,
or the lining of the brain and spinal cord, causing meningitis. Such infections
can cause brain damage and, in rare cases, death.
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- Each year in the United States, there are about 16,000
cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis
among children under age five.
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- Prevnar, when given to about 19,000 children in a clinical
trial, was 100 percent effective in preventing invasive disease caused
by the seven strains that the vaccine targets. Those strains cause 80 percent
of all infections caused by pneumococcus, also known as Streptococcus pneumoniae.
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- AHP also is studying Prevnar's usefulness against middle
ear infections and pneumonia. Dr. Jesse Goodman, deputy director of the
FDA's Center for Biologics, said ``there is reason to be hopeful'' that
the vaccine would work against those infections ''but we're waiting to
fully have the data.''
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- Side effects were generally mild, including irritability,
drowsiness, decreased appetite and reactions at the injection site, the
FDA said. Some children also experienced fevers.
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- Wednesday, a committee of the Centers for Disease Control
and Prevention recommended Prevnar for all children up to age 2 and children
at high risk for infections up to age 5.
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- The vaccine costs $58 per dose, with four doses recommended
before children reach 15 months of age. Only one dose is needed after that.
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- Industry analysts said they expected widespread use of
Prevnar. The vaccine's success is considered to be important to the future
of AHP, which has failed to close three merger deals in the past two years.
AHP's products include the painkiller Advil and hormone replacement therapy
Premarin.
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- ``Prevnar is a really important drug, especially in the
next few years,'' said Chase Hambrecht and Quist analyst Alex Zisson, who
predicted between $300 million and $500 million in sales this year. ``New
vaccines get off to a very fast start.''
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- The approval also gives a boost to the company's vaccine
unit, Wyeth Lederle Vaccines, which last year withdrew a children's vaccine
against rotavirus, a cause of severe diarrhea, after the vaccine was linked
to bowel obstructions.
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- AHP had called the vaccine Prevenar but changed the name
to Prevnar.
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