Sanofi wins U.S. approval to sell dengue vaccine but with major restrictions

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Sanofi wins U.S. approval to sell dengue vaccine but with major restrictionsThe FDA says the drug may only be given to people aged 9 through 16 who have laboratory-confirmation of a previous dengue infection and live in areas where the disease is prevalent, such as Puerto Rico, the U.S. Virgin Islands and American Samoa. Sanofi had sought a much broader approval that would have included people aged 9 to 45, but an FDA advisory panel in March recommended the narrower age range, excluding its use in adults. 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.


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