FDA Advisory Committees
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Latest From Advisory Committees
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.
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.
Company proposes enhanced real-world monitoring to identify dengue vaccine’s risks, including severe and hospitalized dengue in individuals not previously infected, US FDA says in briefing document for March 7 advisory committee meeting.
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