The U.S. Food and Drug Administration said it approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine, for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research, said, “According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia. 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.” FDA noted that 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. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.

http://www.prnewswire.com/news-releases/fda-expands-use-of-prevnar-13-vaccine-for-people-ages-50-and-older-136440078.html