Pneumonia Vaccine

Posted on Jan 10, 2012 in News | 0 comments

FDA Approves Expanded Use of Prevnar 13 Vaccine in Patients Aged 50 and Older

 

  Print This Post
With winter and flu season encroaching on much of the United States, we thought you’d be interested in the latest FDA approval to prevent pneumonia in older adults.

Prevnar 13® (Pfizer, Inc), a pneumococcal 13-valent conjugate vaccine, was just approved by the U.S. Food and Drug Administration for people aged 50 years and older to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae.[1] Prevnar 13 joins Pneumovax® 23 (Merck) as the only two approved vaccines for this indication in this age group. Prevnar 13 is the same vaccine already approved for use in children ages 6 weeks through 5 years for preventing streptococcal pneumonia and otitis media caused by seven of the bacterial serotypes.

Pneumococcal pneumonia is the most common disease caused by this bacterium in adults. It is estimated that approximately 300,000 U.S. adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia, which is a substantial cause of illness and death in this age group.

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. 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. An additional trial in 85,000 people ages 65 and older is underway to confirm the clinical benefit of Prevnar 13 in the prevention of pneumococcal pneumonia; patients in this trial have had no prior previous history of receiving Pneumovax 23.

In randomized, multi-center studies in the United States and Europe, people 50 and older received either Prevnar 13 or Pneumovax 23. The studies showed that for the 12 common serotypes, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.

The safety of Prevnar 13 was evaluated in about 6,000 people ages 50 and older who received Prevnar 13 and who had and had not previously received Pneumovax 23. Common adverse reactions reported with Prevnar 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.

For more information about which adults are candidates for vaccination, read Pneumoccoccal Disease: Hard to say it; Easy to get vaccinated.

Published on January 10, 2012

Reference

1. FDA expands use of Prevnar 13 vaccine for people ages 50 and older. U.S. Food and Drug Administration (FDA) Website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm285431.htm. Published December 30, 2011. Accessed January 6, 2012.