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Philippines FDA directs Sanofi to withdraw Dengvaxia, suspend sales

The Philippines Food and Drug Administration directed Sanofi to withdraw its dengue vaccine from the market and suspend the sale, distribution and marketing of Dengvaxia pending regulatory compliance.

The agency also directed Sanofi to conduct an information dissemination campaign amid a government probe into the immunization of more than 730,000 children who received the treatment.

The French drugmaker revealed Nov. 29 that Dengvaxia could worsen the disease in people not previously infected.

The Philippines FDA is closely coordinating with the Department of Health for any adverse events and reactions.