Sanofi Pasteur, the vaccines division of Sanofi SNY
, 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.
"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.
Dengue disease burden globally
According to the WHO, dengue is the fastest growing mosquito-borne disease in the world today, causing nearly 400 million infections every year. In the last 50 years dengue has spread from being present in a handful of countries to being endemic in 128 countries, where about 4 billion people live, and dengue incidence has likewise increased 30-fold in this time period. ,
Although dengue affects people from all ages and socio-economic backgrounds, the greatest number of dengue cases worldwide occurs in the highly mobile and social segment of endemic populations that include preadolescents to adult ages of 9 years and older.
Dengue disease burden in Brazil
This year, over 1.4 million Brazilian citizens were reportedly sickened by the virus. On top of this considerable human suffering, the cost of dengue is substantial in terms of direct medical costs, as well as indirect losses such as lowered work productivity. Estimated spending on dengue disease for Brazil is $1.2 billion USD every year; an average of $448 USD per hospitalized case and $173 USD per ambulatory case.