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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Long-anticipated findings for Japanese firm’s dengue vaccine show efficacy rates above its only rival, including in those not previously exposed to the virus, but results for different strains were mixed and experts are awaiting additional data due in the next few weeks.
CDC advisory committee cannot recommend administration of Sanofi's dengue vaccine until there is an acceptable test to detect previous dengue infection and other questions are answered.
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.