FDA Fast-Tracks Pfizer's C Difficile Vaccine

Vaccine targets the diarrhea-causing bacterium linked to 14,000 US deaths annually.

Pfizer Inc announced that the FDA has given fast track designation to its investigational Clostridium difficile (C difficile) vaccine candidate.

The vaccine is geared toward preventing C difficile—associated disease, which may include life-threatening diarrhea and pseudomembranous colitis. Pfizer says it is currently in the phase 2 clinical trial stage.

“C. difficile is a growing, difficult-to-treat healthcare-associated infection,” said Emilio Emini, MD, senior vice president of 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 offers fast track designation to products that treat serious diseases and fill unmet medical needs. On the fast track, drugs are tested and examined for safety issues more quickly.

C difficile causes diarrhea linked to 14,000 American deaths each year, according to the Centers for Disease Control and Prevention. It causes inflammation of the colon after an individual is on antibiotics for a prolonged period of time.

Illnesses that stem from C difficile typically affect older adults, specifically those who are hospitalized. It is often detected after an individual has been using antibiotic medications. As a result, patients are required to remain hospitalized for longer periods, putting a burden on health care facilities.