CHICAGO - The US Food and Drug Administration on Wednesday approved Sanofi SA's dengue vaccine Dengvaxia for use in the United States among people aged 9 through 16 who have laboratory-confirmed previous dengue infection and live in endemic areas.
In late 2017, Sanofi disclosed that Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, triggering a government investigation in the Philippines where 800,000 school-age children had already been vaccinated.
In March, the Philippine Justice Department said it found probable cause to indict Sanofi officials and former Philippine health officials over 10 deaths it said were linked to the dengue vaccine. Sanofi has said it "strongly disagrees" with those findings.
Dengvaxia is not approved for use in individuals not previously infected by any form of the dengue virus, the FDA said.
Mosquito-borne dengue is the world's fastest-growing infectious disease, afflicting hundreds of millions of people worldwide. It causes half a million life-threatening infections and kills about 20,000 people, mostly children, annually.
Last spring, the World Health Organization said Sanofi's vaccine should only be used on individuals with proven prior dengue exposure, significantly reducing the potential market for Dengvaxia, the world's first dengue vaccine which had been seen as a potential $1 billion a year product.
In December, Dengvaxia won European approval for people aged 9 to 45 living in endemic areas who have a documented prior infection.
"Today's FDA approval of Dengvaxia allows us to bring a critical medical prevention tool to at-risk populations, helping combat and prevent dengue, particularly among children, in U.S. dengue endemic areas," Dr. David Greenberg, Sanofi's regional medical head for North America, said in a statement.
Endemic areas include Puerto Rico, the US Virgin Islands and American Samoa.