The scope of Sanofi Pasteur’s Research & Development activities is vast and complex, encompassing the entire chain of events before a new vaccine becomes available – from understanding a disease and its biological foundations, to clinical development and testing, to obtaining health authorities’ approval for marketing the new vaccine.
We have currently 11 vaccines in development(1) or submitted for approval to meet the specific needs of different segments of the population (flu, vaccines combination, etc.) or unmet medical needs (dengue, hospital-acquired infections, etc.).
(1) October 28th 2016, phase I to registration
(2) Registered in Europe in February 2016
Hospital-acquired infections are a major concern for public health in many industrialized countries and cause significant annual costs to the healthcare systems.
Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease.
The risk of contracting CDI increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. A main source of C. diff is infected patients who release spores into the environment that can then infect other people. When antibiotics disrupt the gut’s normal flora and a person has ingested C. diff spores, the C. diff bacteria multiply and release potent toxins that can damage a person’s intestinal lining and cause C. diff disease.
Our investigational vaccine is designed to help protect at-risk individuals from C. diff, which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide. (i)
Sanofi Pasteur's candidate vaccine against Clostridium difficile takes a toxoid-based approach, which has been used extensively in Sanofi Pasteur's licensed vaccines against tetanus, diphtheria and pertussis (whooping cough). In August 2013, the company initiated a Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of its investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI). The Cdiffense Phase III clinical program will include up to 15,000 adults at 200 sites across 17 countries. A Phase II study of the vaccine against Clostridium difficile was done in the United States. The U.S. FDA has granted fast-track designation to Sanofi Pasteur's investigational Clostridium difficile vaccine.
• See the Focus on Clostridium difficile
(i) Centers for Disease Control and Prevention. Frequently Asked Questions about Clostridium difficile for Healthcare Providers. Centers for Disease Control and Prevention. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html. Last Updated March 6, 2013. Accessed June 26, 2013.