Pfizer announced that the Food and Drug Administration (FDA) has granted Fast Track status for its investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).

The vaccine is currently under Phase 2 clinical development where it is being investigated for the prevention of C. difficile-associated disease, including life-threatening diarrhea and pseudomembranous colitis.

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Currently there are no FDA approved vaccines available to prevent C. difficile-associated infections. According to the Centers for Disease Control (CDC), there are approximately 250,000 cases of C. difficile-associated disease, resulting in about 14,000 deaths annually. The Fast Track designation will allow Pfizer to work closely with the FDA to develop and expedite the review of the vaccine to prevent infection and address an unmet medical need.

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