FDA Expands Use of Prevnar 13 Vaccine

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.

Prevnar 13, a pneumococcal 13-valent conjugate vaccine manufactured by Wyeth Pharmaceuticals, was approved by the U.S. FDA for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

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.

In randomized, multi-center studies in the United States and Europe, people 50 and older received either Prevnar 13 or Pneumovax 23, a licensed pneumococcal vaccine also approved for use in this age group. Th