Sanofi and its vaccines global business unit Sanofi Pasteur, announced today that the Strategic Advisory Group of Experts on Immunisation (SAGE) has issued its recommendations to the WHO on the use of Dengvaxia dengue vaccine.
The SAGE advises that countries with high dengue transmission consider introduction of the dengue vaccine as part of an integrated disease prevention strategy including vector control to effectively lower their dengue disease burden. Successful introduction of dengue immunisation alongside other prevention efforts should help endemic countries to achieve the WHO objectives to reduce dengue morbidity by 25 per cent and mortality by 50 per cent by 2020.
“We welcome these recommendations for Dengvaxia from SAGE, the advisory group to the WHO, for vaccines and immunisation,” 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 per cent 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 programme (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 27, 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 per cent of severe dengue cases.
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.
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunise 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.