Dr. Karen Midthun, director of U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, said pneumococcal pneumonia, caused when the bacterium Streptococcus pneumoniae infects the lungs, is the most common disease caused by this bacterium in adults.
When the bacterium invades parts of the body that are normally free from germs, such as the blood or spinal fluid, the disease is considered "invasive," Midthun said.
"According to recent information for the United States, it is estimated that approximately 300,000 adults age 50 and older are hospitalized yearly because of pneumococcal pneumonia," Midthun said in a statement. "Pneumococcal disease is a substantial cause of illness and death. Today's approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group."
The new use for Prevnar 13 was approved under the agency's accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses, Midthun said.
The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.
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