Sanofi received 1st regulatory approval for dengue vaccine, DENGVAXIA®

Sanofi Pasteur, the vaccines division of Sanofi, announced 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 endemicareas.

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.

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.

About Sanofi Pasteur’s dengue vaccine

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 clinical study program (phase I, II and III), of whom, 29,000 volunteers received the vaccine. Dengvaxia^® successfully completed phase III clinical studies in 2014 to evaluate the primary objective of vaccine efficacy.

Long-term follow-up studies of the vaccine, recommended by WHO for all dengue vaccines in development, are currently ongoing. Additional pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were recently published in The New England Journal of Medicine reconfirming the vaccine’s consistent efficacy and longer-term safety profile in populations 9 years of age and older. In a pooled efficacy analysis in volunteers aged 9-16 who participated in the two Phase III 25-month efficacy studies, Dengvaxia^® was shown to reduce dengue due to all four serotypes in two-thirds of the participants. Furthermore, this pooled efficacy analysis showed that Dengvaxia^® prevented 9 out of 10 cases of severe dengue and 8 out 10 hospitalizations due to dengue in this age group.

Dengvaxia^® is the first vaccine licensed for the prevention of dengue in the world. First doses of the vaccine have been produced and full scale production capacity will be reaching 100 million vaccine doses annually.