FDA Fast Tracks Pfizer's Anti-Infection Vaccine

Pfizer reported that its investigational vaccine candidate PF-06425090 against Clostridium difficile (C. difficile) has received Fast Track designation from the U.S. Food and Drug Administration (FDA).

PF-06425090 is a vaccine candidate under development for the prevention of C. difficile-linked disease, which includes serious illnesses such as pseudomembranous colitis and antibiotic-associated diarrhea (AAD), for which it accounts for 15 to 25 percent of all episodes.

Dr. Emilio Emini, SVP of Vaccine R&D for Pfizer, said, “C. difficile is a growing, difficult-to-treat healthcare-associated infection. 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.”

C. difficile is a Gram-positive, spore-forming anaerobic bacillus that produces the two exotoxins toxin A and B. It is the leading cause of healthcare-related infections and usually occurs following use of antibiotics. While the infection is commonly observed in older adults in long term care facilities and hospitals, infection rates have been growing in younger and healthy individuals. C. difficile infections place a significant strain on healthcare facilities and increases the costs and length of stay of patients in hospitals.

The Fast Track designation accelerates the development and review of investigational drugs and vaccines that address serious conditions and unmet medical need.

Aside from its investigational C. difficile vaccine, the company has also received Breakthrough Therapy designation from the FDA for its investigational vaccine candidate bivalent rLP2086 for the treatment of meningococcal B disease. Invasive meningococcal disease caused by Neisseria meningitidis serogroup B affects between 20,000 and 80,000 around the world every year and can end in death or serious long-term disabilities.

In July, Pfizer expanded its portfolio of vaccines when it announced its plans to acquire Baxter International’s portfolio of commercialized vaccines for $635 million. The pharma giant will also acquire part of Baxter’s vaccine manufacturing facility in Austria.