Pfizer gains fast track designation for investigational C. difficile vaccine

NEW YORK — Pfizer last week announced that the Food and Drug Administration has granted fast track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). 

 

Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.

 

“C. difficile is a growing, difficult-to-treat healthcare-associated infection,” stated Emilio Emini, SVP Vaccine Research and Development for Pfizer. “No vaccine is currently available to prevent the infection-associated disease. In the United States alone, there are approximately 250,000 cases of C. difficile-associated disease, resulting in approximately 14,000 deaths each year.”

 

The FDA’s fast track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.