HealthDay News — The FDA has approved the 13-valent pneumococcal conjugate vaccine (PCV13, Prevnar 13, Wyeth Pharmaceuticals) for people aged 50 years and older.
The vaccine targets bacterial pneumonia and other diseases caused by 13 serotypes of the pathogen Streptococcus pneumoniae, and has already been approved for children aged 6 weeks through 5 years to prevent invasive disease and otitis media, according to an agency press release.
The new indication was granted using the accelerated approval pathway, which allows drug manufacturers to use an immune marker that reasonably demonstrates clinical benefit for a serious or life-threatening condition, the FDA said.
In clinical testing for the expanded use of the vaccine, people 50 and older were either given PCV13 or another licensed pneumonia vaccine, the 23-valent pneumococcal polysaccharide vaccine (PPSV23, Pneumovax 23, Merck). Study results indicated PCV13 induced levels of immune system antibodies that were either comparable or higher than those associated with PPSV23.
Patients showed a similar adverse event profile with both vaccines, the most common including injection-site swelling, redness and pain, fatigue, headache, chills, muscle pain and joint pain.
Another post-approval study involving 85,000 people aged 65 years and older is ongoing to verify clinical benefit as part of the accelerated approval process, according to the FDA.
The U.S. Centers for Disease Control and Prevention has more about pneumococcal disease.