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Sanofi's dengue vaccine gets FDA clearance—with restrictions.

· Health Alert

With more than one-third of the world’s population living in areas at risk for infection, dengue virus is a leading cause of illness and death in the tropics and subtropics. So, even though there are critical caveats, this is a big step forward.

 

The Food and Drug Administration (FDA) has green lighted French drug giant Sanofi's dengue vaccine—but with some major caveats. The treatment has come under fire internationally (specifically in the Philippines) over post-marketing research that found it can actually worsen the disease when given to children who have never contracted dengue before. As such, Dengvaxia is only cleared for use U.S. regions where the disease is prevalent, and for patients who have had tests confirming they've contracted it previously.

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