Vaccine to Prevent Pneumococcal Pneumonia Approved for Use in Patients 50 and Older

January 11, 2012 8:14 pm

FDA approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine, for use in patients 50 years of age and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, indicated that approximately 300,000 adults 50 and older are hospitalized with pneumococcal pneumonia each year. 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, and additional details about the approval process are available in an FDA press release. Prevnar 13 was already approved for use in children ages six weeks through five years for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae and for the prevention of otitis media caused by seven of the serotypes of the bacterium. As noted by FDA, the approval of Prevnar 13 for adults 50 years of age and older supports Department of Health and Human Services (HHS) Healthy People 2020 objectives.