In randomised, multi-center studies in the United States and Europe, adults aged 50 and older received either Prevenar 13®, which contains 13 different serotypes of the bacterium Streptococcus pneumonia or Pneumovax® 23, the pneumococcal polysaccharide vaccines which conatins 23 different serotypes of the bacterium. The studies showed that for the 12 serotypes common to both vaccines, Prevenar 13® induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax® 23.
The safety of Prevenar 13 was evaluated in about 6,000 adults aged 50 and older who received Prevenar 13® and who had and had not previously received Pneumovax® 23. Common adverse reactions reported with Prevenar 13® were pain, redness, and swelling at the injection site, limitation of movement of the injected arm, fatigue, headache, chills, decreased appetite, generalized muscle pain, and joint pain. Similar reactions were observed in those who received Pneumovax® 23.
The new use for Prevenar 13® was approved under the agency's accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses, to prevent pneumonia and invasive disease caused by the bacterium in older adults. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.
Accelerated approval is granted on the condition that a clinical trial is conducted during the post-approval marketing of the vaccine to verify the anticipated clinical benefit in adults 50 years of age and older. An additional trial in 85,000 adults aged 65 and older, with no previous history of receiving Pneumovax® 23, is underway to confirm the clinical benefit of Prevenar 13® in the prevention of pneumococcal pneumonia.