First marketing authorization of Dengvaxia is a historic milestone paving the way to significantly impact dengue burden in endemic countries
Sanofi Pasteur, the vaccines division of Sanofi, announced that the Mexican authorities have granted marketing authorisation 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, nine to 45 years of age living in endemic areas.
The COFEPRIS approval of Dengvaxia is based on results from an extensive clinical development programme 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.
Regulatory review processes for Dengvaxia are continuing in other endemic countries. Manufacturing of Dengvaxia has already started at vaccine facilities in France and first doses are already produced. Sanofi Pasteur remains committed to introducing Dengvaxia first in countries where dengue is a major public health priority.