Sanofi will ask a US FDA advisory committee tasked with reviewing Dengvaxia to consider an extensive global postmarketing monitoring plan aimed at addressing safety concerns that have arisen with the controversial dengue vaccine.
Sanofi's Dengvaxia Postmarket Monitoring Plan Targets Vaccine's Safety Concerns
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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