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Sanofi’s Dengvaxia: US FDA Panel Finds Pediatric Use More Acceptable Than Broader Target Population

 
• By Sue Sutter

Even a more limited label for the dengue vaccine may not be enough to overcome the lack of a readily available and reliable point-of-care diagnostic for screening potential vaccine recipients for previous dengue infection.

FDA Advisory Committee Feature image

Sanofi’s hopes for US FDA approval of its dengue vaccine Dengvaxia may hinge upon a pediatric indication following a strongly negative advisory committee review, particularly regarding licensure for a broader age group.

However, even a more limited label may not be enough to overcome what advisory committee members saw as a key...

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