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CHICAGO – The US Food and Drug Administration on Wednesday approved the use of Sanofi SA dengue fever vaccine in the United States for people aged 9 to 16 who have already contracted dengue fever and are living in endemic areas.
Sanofi revealed in late 2017 that dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, which triggered a government investigation in the Philippines, where 800,000 children of age to attend school had already been vaccinated.
In March, the Philippine Justice Ministry said it had found a likely cause to charge officials of Sanofi and former health officials in the Philippines, causing more than 10 deaths, allegedly linked to Dengue vaccine. Sanofi says "strongly disagrees" with these findings.
Dengvaxia is not approved for use in individuals previously uninfected by any form of the dengue virus, the FDA said.
Mosquito-borne dengue fever is the fastest growing infectious disease in the world and affects hundreds of millions of people around the world. It causes half a million life-threatening infections and kills around 20,000 people, mostly children, every year.
Last spring, the World Health Organization declared that the Sanofi vaccine should only be used in people already exposed to dengue, which would significantly reduce the potential market for dengvaxia, the world's first dengue vaccine , considered a potential product of one billion dollars a year.
In December, Dengvaxia was approved in Europe for people aged 9 to 45 living in endemic areas with documented previous infection.
"FDA approval of dengvaxia now allows us to provide a critical medical prevention tool for at-risk populations, helping to combat and prevent dengue fever, especially among children, in the general population. Dengue endemic areas in the United States, "said Dr. David Greenberg, Sanofi's regional medical officer for North America. said in a statement.
Endemic areas include Puerto Rico, the US Virgin Islands and American Samoa.
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