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

Executive Summary

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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Dengvaxia’s Restrictive Indication Will Make Immunization Recommendations Difficult, ACIP Members Say

The need to screen individuals in dengue-endemic areas for prior infection before administering Sanofi’s vaccine will be difficult to operationalize, particularly in the absence of a reliable and rapid diagnostic, experts say; Advisory Committee on Immunization Practices working group aims for full committee vote on use recommendations in February 2020.

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