Sanofi wins FDA approval to sell dengue shot in parts of U.S.

CHICAGO: The U.S. 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.