Lyon, France – December 28, 2015 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that Brazil has granted regulatory approval to Dengvaxia®, representing the third successful licensure of the dengue vaccine, which was also approved in Mexico and the Philippines earlier this month.
The Brazilian regulatory authorities ANVISA approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas.
Dengue continues to hit hard in Brazil with over 1.4 million Brazilians directly affected by the disease during this year’s outbreak season alone. Up to 70% of dengue cases in Brazil are reported in individuals 9 years and older, a highly mobile and socially active segment of the population who contributes to the spread of the disease within communities.
Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalizations due to dengue and up to 93% of severe dengue cases.1
“This new Approval of Dengvaxia® by the ANVISA, a well-recognized and World Health Organization (WHO) certified regulatory authority is an important milestone for Sanofi Pasteur,” says Guillaume Leroy, Vice President of Dengue Vaccine, Sanofi Pasteur. “Dengvaxia® has the potential to significantly reduce the dengue disease burden and to help Brazil reach the WHO’s 2020 dengue reduction objectives.”
“Approval of the first dengue vaccine is an important public health breakthrough with critical importance to our country, which bears the greatest dengue burden in Latin America,” says Joao Bosco Siqueira Junior of the Department of Community Health, Institute of Tropical Pathology and Public Health, Federal University of Goias, Goiania, Brazil. “The 2015 dengue outbreak is still very present in the minds of Brazilians so Dengvaxia’s approval is a most welcome addition to our ongoing dengue prevention efforts.”
Dengue is a major public health priority in tropical and subtropical countries in Latin America and Asia. Sanofi Pasteur is introducing Dengvaxia® first in these countries where the vaccine has the greatest potential to reduce dengue burden globally and help to achieve the WHO’s goal to reduce dengue mortality by 50% and morbidity by 25% by 2020 in endemic countries. Sanofi Pasteur enrolled over 40,000 participants in extensive safety and clinical efficacy studies conducted mainly in endemic countries and built a dedicated vaccine production facility in France to secure adequate quality and quantity supply of the vaccine to meet endemic country demand upon introduction.