Dr Elias Zerhouni, MD, President of Global R&D, Sanofi
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 immunization alongside other prevention efforts should help endemic countries to achieve the WHO objectives to reduce dengue morbidity by 25% and mortality by 50% by 2020.
"We welcome these recommendations for Dengvaxia from SAGE, the advisory group to the WHO, for vaccines and immunization." said Dr 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.