(Eagle News) — The Food and Drug Administration has ordered the suspension of the sale, distribution, and marketing of Dengvaxia.
The order, which also covered the withdrawal of the product from the market, was contained in FDA Advisory 2017-318 dated Dec. 4, 2017.
The FDA issued the advisory following Sanofi’s admission the vaccine could cause “serious cases” in those who have not had the virus.
The FDA also directed Sanofi to hold an information dissemination campaign about its product, and urged medical personnel to report to the FDA any incident “that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person.”
“(We) will immediately take appropriate measures to protect the public,” the FDA said.
