US OKs New
Vaccine For Children
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.
The Food and Drug Administration said it cleared Prevnar, made by American Home Products Corp, for preventing certain pneumococcal infections in infants and toddlers.
Pneumococcal infections kill more than a million children worldwide every year and are growing resistant to antibiotics.
``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.
Prevnar, which analysts expect to be a major new product for AHP, will be available within the next two weeks, a company spokeswoman said.
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.
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.
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.
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.''
Side effects were generally mild, including irritability, drowsiness, decreased appetite and reactions at the injection site, the FDA said. Some children also experienced fevers.
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.
The vaccine costs $58 per dose, with four doses recommended before children reach 15 months of age. Only one dose is needed after that.
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.
``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.''
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.
AHP had called the vaccine Prevenar but changed the name to Prevnar.


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