Brazil OKs Sanofi’s Dengue VaccineBy
Sanofi Pasteur, the vaccines division of Sanofi, reports that Brazil has granted regulatory approval to Dengvaxia, the company’s vaccine for dengue disease representing the third successful licensure of the dengue vaccine, which was also approved in Mexico and the Philippines in December 2015.
The Brazilian regulatory authority, 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 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 World Health Organization’s (WHO) goal to reduce dengue mortality by 50% and morbidity by 25% by 2020 in endemic countries. Sanofi Pasteur has enrolled over 40,000 participants in safety and clinical efficacy studies conducted mainly in endemic countries and built a dedicated vaccine production facility in France to secure adequate quality and 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.