Mexican authorities have granted marketing authorisation to Sanofi Pasteur’s Dengvaxia, making it the first vaccine to be licensed 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.
Olivier Brandicourt, chief executive officer, Sanofi, said: "When Sanofi set out to develop a dengue vaccine 20 years ago it was with the intention of developing an innovative vaccine to tackle this global public health need.
"With this first marketing authorisation of Dengvaxia we have achieved our goal of making dengue the next vaccine-preventable disease. “
The COFEPRIS approval of Dengvaxia is based on results from a 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.
José Luis Arredondo García, associate director of clinical research in the National Institute of Pediatrics, said: "Dengue is a growing health threat in Mexico and many other tropical and subtropical countries in Latin America and Asia. The first vaccine approved to prevent dengue fever is a major innovation and a public health breakthrough.
“Dengvaxia will be a critical addition to the integrated dengue prevention and control efforts. It will be an essential tool to boost on-going community efforts to relieve the long-standing suffering that this disease continues to bring to people in endemic countries like ours."
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.