Lyon, France – December 9, 2015 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that the Mexican authorities have granted marketing authorization to Dengvaxia®, making it the first vaccine to be licensed in the world for the prevention of dengue.
December 11th, 2015Lyon, France – December 9, 2015 – “Sanofi Pasteur, the vaccines division of Sanofi, announced today that the Mexican authorities have granted marketing authorization to Dengvaxia®, making it the first vaccine to be licensed in the world for the prevention of dengue.
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in preadolescents, adolescents and adults, 9 to 45 years of age living in endemic areas…..
The COFEPRIS approval of Dengvaxia® is based on results from an extensive clinical development program involving over 40,000 people of different ages, geographic and epidemiological settings, and ethnic and socio-economic backgrounds living in 15 countries. Dengue-endemic regions of Mexico participated in all three phases of the clinical development program for the vaccine…..Disease impact modelling results indicate if you vaccinate 20% of the population in the 10 endemic countries that participated in the Phase III efficacy studies for Dengvaxia, in the ages 9 and above indication, you could potentially reduce your dengue burden by 50% in five years. Such a significant disease reduction in this large at-risk population would result in a smaller pool of infected individuals in a given country and, therefore, fewer mosquitoes capable of transmitting the disease, potentially leading to an overall lowering of transmission risk for all…….”