Sanofi Pasteur, the vaccines division of Sanofi, has gotten from Brayil regulatory approval to Dengvaxia.
As the company said Monday , the approval represents 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.
“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.”
Joao Bosco Siqueira Junior of the Department of Community Health, Institute of Tropical Pathology and Public Health, Federal University of Goias, Goiania, Brazil, said:
“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.”
“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.”