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The vaccine targets pneumonia and other diseases caused by the bacterium Streptococcus pneumoniae. The shot, targeting 13 serotypes of the bacterium, has already been approved for children aged 6 weeks through 5 years to prevent invasive disease and certain ear infections, the agency said in a news release.
In clinical testing for the expanded use of the vaccine, people 50 and older were either given Prevnar 13 or another licensed pneumococcal vaccine, Pneumovax 23. The studies found Prevnar 13 induced levels of immune system antibodies that were either comparable or higher than those of Pneumovax 23, the FDA said.
An additional study in 85,000 people aged 65 or older is ongoing, the agency said.
Prevnar 13 is produced by Wyeth Pharmaceuticals, based in Collegeville, Penn.
-- Scott Roberts
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