FDA fast-tracks review of Pfizer's C. difficile vaccine

Pfizer announced on Thursday that the U.S. Food and Drug Administration (FDA) has fast-tracked the review of the company's Clostridium difficile (C. difficile) vaccine, which is currently in stage two of clinical development.

C. difficile, according to Pfizer, is the most frequent cause of healthcare-associated infections, causing inflammation of the colon, which subsequently leads to symptoms such as diarrhea, fever and loss of appetite.

It is a bacterium that most commonly affects older adults in hospitals or long-term care facilities and generally occurs after a round of antibiotics is given to the patient, though new studies indicate the rate of infection in groups not considered high risk is on the rise.

"C. difficile is a growing, difficult-to-treat healthcare-associated infection," Emilio Emini, the senior vice president of vaccine research and development for Pfizer, said. "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."

According to Pfizer, C. difficile infection substantially increases hospital costs, the length of stay for patients and contributes to mortality.

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U.S. Food and Drug Administration (FDA)

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