Pneumonia vaccine approved for over-50 age group
Prevnar 13, a vaccine to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae bacteria, has been approved by the FDA for persons 50 and over. The vaccine previously was approved only for use in children ages 6 weeks through 5 years.
The FDA estimates 300,000 adults age 50 and older are hospitalized each year with pneumococcal pneumonia. Expanded approval of Prevnar 13 "provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group," says Karen Midthun, M.D., an FDA director.
Safety of the vaccine was evaluated in multi-center studies involving about 6,000 people 50 and older who had not received Pneumovax 23 (a pneumonia vaccine previously approved by the FDA and currently in use). According to the results, Prevnar 13 was as effective as Pneumovax 23.
The expanded use of the vaccine was approved under the FDA's accelerated approval pathway, which essentially fast-tracks approval of treatments for serious and life-threatening conditions. Accelerated approval requires that a clinical trial take place after a drug or vaccine is approved in order to confirm its benefits. Another trial of 85,000 people 65 and older is under way.
Common adverse side effects of Prevnar 13 reported by study participants were similar to side effects reported in conjunction with use of Pneumovax 23. They include pain, redness and swelling at the injection site, fatigue, headache, and chills.