The U.S. Food and Drug Administration has granted Fast Track designation to Pfizer's investigational Clostridium difficile vaccine, which is in Phase 2 clinical development.
The FDA's Fast Track is designed to facilitate the development and expedite the review of new vaccines intended to treat or prevent serious conditions and address unmet medical need, according to Pfizer.
Pfizer's vaccine is designed to prevent diseases associated with C. diff, which can include life-threatening diarrhea and pseudomembranous colitis. Currently, there is no C. diff vaccine, even though C. diff- related diseases lead to about 14,000 deaths in the United States each year.