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Sanofi's Dengvaxia Postmarket Monitoring Plan Targets Vaccine's Safety Concerns

 
• By Sue Sutter

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.

Stop dengue. Syringe is filled with injection. Syringe and vaccine

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 “has proposed both routine and enhanced pharmacovigilance monitoring to identify risks that could be associated with Dengvaxia, including allergic reactions, severe and hospitalized dengue in individuals not previously infected by dengue virus, as well as risks that have not been previously recognized,” FDA said in its briefing

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