Dengvaxia® First Dengue Vaccine Approved in Brazil
– Global introduction of the first Dengue Vaccine gains further momentum with this third approval in a row in an endemic country –
– With 1.4 million dengue cases reported this year, Brazil stands to gain tremendous value from this new dengue prevention tool

Lyon, France – December 28, 2015 – Sanofi Pasteur, the vaccines division of Sanofi, 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.[1] …

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SANOFI PASTEUR’S DENGUE VACCINE APPROVED IN THE PHILIPPINES
– Dengvaxia®’s first approval in Asia reaffirms company’s vision for priority introduction of the dengue vaccine in endemic countries globally

Lyon, France – December 22, 2015 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that the Philippines have granted marketing approval to Dengvaxia®, making it the first vaccine to be licensed for the prevention of dengue in Asia.

The Philippines’ Food and Drug Administration 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.

“Approval of the first dengue vaccine in Asia, which bears 70% of global disease burden[1], is a major milestone in dengue prevention and public health,” notes Olivier Charmeil, President and CEO of Sanofi Pasteur. “Approval of Dengvaxia® in the Philippines, following closely the first approval in Mexico, is further evidence of Sanofi Pasteur’s long-standing commitment to introduce this innovative new vaccine first in countries where dengue is a major public health threat…

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Sabin Vaccine Institute
http://www.sabin.org/updates/pressreleases
Statement by the Dengue Vaccine Initiative on the Philippines Regulatory Approval of Sanofi Pasteur’s Dengue Vaccine, Dengvaxia
Wednesday, December 23, 2015
…The Dengue Vaccine Initiative (DVI) is encouraged by the growing momentum in global dengue prevention and control strategies. Together with Mexico’s approval of Dengvaxia® and Brazil’s recent authorization for a Phase III study of Instituto Butantan’s dengue vaccine candidate, DVI views the Philippines’ licensure as the latest development in an ongoing effort to deliver innovative, comprehensive dengue prevention and control strategies. The Philippines’ approval of Dengvaxia® also will help answer remaining questions about Dengvaxia®, including duration of protection, price, and impact on overall dengue virus transmission, especially in age groups not vaccinated…