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