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Sanofi's Dengue Vaccine Gets WHO Backing In People Previously Infected

Executive Summary

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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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.

Controversial Dengue Drug Among Six Products To Get EMA Thumbs Up

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.

Brakes On Sanofi’s Dengvaxia Prospects Amid WHO-SAGE Screening Advice?

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.

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