Brazil Becomes Third Country to Approve Sanofi's Dengue Vaccine
Sanofi announced on Monday that Brazil has given its regulatory approval for their dengue fever vaccine called Dengvaxia®. Brazil became the third country in the world after Mexico and the Philippines to allow the use of the first-ever licensed vaccine for the prevention of the mosquito-borne disease.
"This new Approval of Dengvaxia® by the ANVISA, a well-recognized and World Health Organization certified regulatory authority is an important milestone for 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," Vice President of Sanofi's vaccine division of Sanofi Pasteur, Guillaume Leroy, said in a press release on the company's official website.
Dengue affected more than 1.4 million Brazilians during 2015's outbreak season with 70 percent of the cases in people nine years and older. Individuals who contact the disease are very socially active that it contributes to the spread of dengue fever within their communities.
"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," Joao Bosco Siqueira Jr. said.
Siqueira is a member of the Department of Community Health, Institute of Tropical Pathology and Public Health, Federal University of Goias. Brazil also participated in the Global Phase III of efficacy studies of Sanofi Pasteur in 2014 that included 10 countries and more than 30,000 volunteers.
According to WHO, dengue is a viral disease that is transmitted by female mosquitoes, specifically the Aedes aegypti, and in some cases by Aedes albopictus. The disease is prevalent throughout tropical countries and was first documented in the 1950s during an epidemic in the Philippines and Thailand.
In the present time, dengue now affects most Asian and Latin American nations and is one of the leading causes of hospitalization and death among children in these regions with an estimated 390 million cases annually. There are four different serotypes of the dengue virus that are closely related called DEN-1, DEN-2, DEN-3 and DEN-4.
Dengvaxia® was developed for more than two decades, undergoing 25 clinical studies in 15 countries with over 40,000 volunteers for Phase I, II and III of Sanofi Pasteur's study program. The vaccine showed consistent efficacy and safety for people aged nine to 16 years old with reduced dengue to all four serotypes. The study also confirmed that Dengvaxia® prevents hospitalization and severe dengue cases by 80 and 93 percent, respectively.
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