Sanofi Gets A Helping Hand From US FDA At Dengvaxia Review
After split verdicts on efficacy and safety for Sanofi’s proposed population for the dengue vaccine, FDA added two new questions limited to pediatric use, which drew strong advisory committee support.
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Communication Hurdles Remain For Sanofi’s Dengue Vaccine
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Sanofi’s Dengvaxia: US FDA Panel Finds Pediatric Use More Acceptable Than Broader Target Population
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.