WHO greenlights Takeda’s dengue vaccine as company plans to ‘re-engage’ with FDA

The World Health Or­ga­ni­za­tion pre­qual­i­fied Take­da’s new dengue vac­cine on Wednes­day, a year af­ter the com­pa­ny with­drew its FDA ap­pli­ca­tion for the can­di­date — though the com­pa­ny now says it will soon “re-en­gage” with the FDA.

The WHO wrote in a state­ment that the vac­cine, known as TAK-003 or Qden­ga, is rec­om­mend­ed for chil­dren 6 to 16 years old in ar­eas with a bur­den and trans­mis­sion of dengue, adding that the vac­cine should be ad­min­is­tered in a two-dose sched­ule with a three-month in­ter­val be­tween dos­es.

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