Sanofi's Dengue Vaccine Gets WHO Backing In People Previously Infected
Label restriction, discussions with regulators should keep vaccine in use, Sanofi suggests; Philippines suspended its vaccination program after data showed product can worsen disease in those not previously exposed to infection.
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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.
Dengvaxia, the dengue vaccine from Sanofi that was suspended in the Philippines last year, is among six new products to get a recommendation for marketing authorization from the European Medicines Agency this week.
WHO’s recommendation around a pre-vaccination screening strategy for Sanofi’s Dengvaxia could potentially dull the prospects of the product further, especially in emerging markets with stretched healthcare resources. One industry expert suggests that governments should probably consider introducing the vaccine only after “better tests and tools” become available.