Strategic Advisory Group of Experts on Immunization Convened by the World Health Organization Recommends Use of Sanofi Pasteur's Dengue Vaccine in Endemic Countries
"We welcome these recommendations for Dengvaxia® from SAGE, the advisory group to the WHO, for vaccines and immunization." said Elias Zerhouni, MD, President of global R&D, Sanofi. "Dengvaxia® has been approved in four countries already, including Mexico and Brazil, which have regulatory authorities recognized by the WHO. These WHO SAGE recommendations further validate the scientific and medical value of Dengvaxia® and send a clear message to endemic countries about the strong public health benefit to be gained by introducing the dengue vaccine in integrated disease management efforts to combat their dengue burden."
Dengvaxia® vaccine's anticipated impact on dengue fever disease burden is expected to stem from the vaccine's proven ability to prevent 8 out of 10 dengue hospitalizations and up to 93% of severe dengue cases--including dengue hemorrhagic fever--in study participants 9 years and older, as demonstrated during 25 months of follow-up of phase III efficacy studies.
The recommendations from the SAGE are based on the technical review of clinical data from 25 clinical studies conducted in 15 different endemic and non-endemic countries around the world, including more than 40,000 study participants.
As of March 2016, Dengvaxia® was licensed in Mexico, the Philippines, Brazil and El Salvador for prevention of dengue from all four serotypes in individuals 9-45 years of age living in endemic areas. Regulatory review processes for Dengvaxia® are continuing in other countries where dengue is a public-health priority. Both public and private vaccinations have already begun in the Philippines and discussions are underway in the other approval countries for launches later this year.
Sanofi Pasteur's vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine development program (phase I, II and III), with 29,000 volunteers receiving the vaccine. Large-scale efficacy studies of Dengvaxia®, including 25-month follow up, were successfully completed in 2014.,
Pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and their ongoing long-term follow-up were published online in The New England Journal of Medicine on July 27th 2015, documenting the vaccine's consistent efficacy and longer-term safety profile in the study population of 9-16 years of age. In the pooled efficacy analysis in this age group, Dengvaxia® was shown to reduce dengue fever due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases.1
Dengvaxia® is the first vaccine in the world licensed for the prevention of dengue fever. The vaccine is produced in a dedicated production site in France, with a full-scale production capacity of 100 million vaccine doses annually.
Additional information about Sanofi Pasteur's dengue vaccine is available at www.dengue.info.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur produces a portfolio of high quality vaccines that match its areas of expertise and ensure a sustainable future. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us
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