Posted January 10, 2012 in
| P C in winter and flu season encroaching on much of the United States, we thought, youd be interested in the recent FDA approval for prevention of pneumonia in the elderly. Prevenar 13 ^ (Pfizer, Inc), 13-valent pneumococcal conjugated vaccine was just approved with the Food and Drug Administration United States for people age 50 and older to prevent pneumonia and invasive disease caused by
pneumococcus. Prevenar 13 joins Pneumovax ^ 23 (Merck), as only two vaccines approved for this indication in this age group. Prevenar 13 is the same vaccine is approved for use in children aged 6 weeks to 5 years to prevent streptococcal pneumonia and otitis media caused by serotypes of bacterial family. Pneumococcal pneumonia is the most common disease vyklykuvanym this bacterium in adults. It is believed that approximately 300 000 American adults aged 50 years and older hospitalized every year because of pneumococcal pneumonia, which is a significant cause of illness and death in this age group. New use of Prevenar 13 was approved under the agency accelerated approval path, allowing earlier approval for the treatment of serious and life-threatening diseases. Path allows you to demonstrate the effectiveness of the vaccine using immune markers, which with a sufficient degree of probability to predict clinical benefit. Accelerated approval is given, provided that clinical trials conducted in the post-approval marketing the vaccine to verify the expected clinical effect. Additional testing of 85,000 people aged 65 and older is to confirm the clinical benefits of Prevenar 13 for prevention of pneumococcal pneumonia, patients in this study had no previous history to receive Pneumovax 23. In a multicenter randomized studies in the United States and Europe, people 50 years and older received Prevnar 13 or Pneumovax 23. Studies have shown that the 12 most common serotypes, Prevenar strattera dosage 13 induced antibody levels that were either comparable to or above the level induced Pneumovax 23. Safety of Prevenar 13 was estimated at about 6,000 people aged 50 years and older who received Prevnar 13 and who had still not received Pneumovax 23. Common adverse reactions reported in the Prevnar 13 were pain, redness and swelling at the injection site, limiting movement of arms entered, fatigue, headache, chills, loss of appetite, generalized muscle aches and joint pain. Similar responses were observed in those who received Pneumovax 23. For more information about what adults are candidates for vaccination to read. Posted January 10, 2012
Links FDA expands use of Prevenar 13 vaccine for people aged 50 years and older. Food and Drug Administration (FDA) site .. Posted December 30, 2011. Reaches 6 January 2012. .