Sanofi Pasteur, the vaccines division of Sanofi, announced 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 per cent 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. 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.
Dengvaxia was shown to reduce dengue due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalisations due to dengue and up to 93 per cent of severe dengue cases.
"This new approval of Dengvaxia by the ANVISA, a well-recognised 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 per cent and morbidity by 25 per cent 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.
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.
Besides Brazil, Dengvaxia is also registered in Mexico and in The Philippines. Regulatory review processes for Dengvaxia are continuing in other countries where dengue is a public health priority.
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 programme (phase I, II and III), of whom, 29,000 volunteers received the vaccine.
Brazil participated in a global phase III efficacy studies including more than 30,000 volunteers from 10 different countries which was successfully completed in 2014.
Pooled efficacy and integrated safety analyses from the 25-month phase III efficacy studies and the ongoing long-term studies, respectively, were published in The New England Journal of Medicine on July 27, 2015, affirming the vaccine's consistent efficacy and longer-term safety profile in study population 9-16 years of age. In the pooled efficacy analysis in this age group, Dengvaxia was shown to reduce dengue due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalisations and up to 93 per cent of severe dengue cases.
Dengvaxia is the first vaccine licensed for the prevention of dengue in the world. First doses of the vaccine have been produced at the dedicated production site in France with planned full-scale production capacity of 100 million vaccine doses annually.