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FDA suspends sale of Dengvaxia dengue vaccine


The Food and Drug Administration of the Philippines ordered the suspension of the sale, distribution, and marketing of Dengvaxia vaccine and the withdrawal of the product in the market.

In FDA Advisory 2017-318 dated Dec. 4, 2017, Nela Charade G. Puno, director general of FDA, said the order was done to protect the general public after the vaccine manufacturer, Sanofi Pasteur, Inc. said Dengvaxia poses potential risk to those who have never had dengue but were vaccinated.

The FDA also ordered Sanofi to conduct an information dissemination campaign with advisories, Dear Doctor Letters, and forums with patients.

Last week, Sanofi Pasteur advised against prescribing Dengvaxia to patients who have not had dengue in the past since it may cause severe diseases in the long run.

After six years of studying clinical data, Sanofi on Wednesday said it has found out that Dengvaxia was only beneficial in the prevention of dengue fever to those who have already suffered from the other serotypes of the virus.

The FDA said it is coordinating with the Department of Health (DOH) closely to monitor any adverse reactions or events reported by recipients of the vaccine.

It added that it "will immediately take appropriate measures to protect the public."

The FDA urged the public and healthcare professionals 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."

Justice Secretary Vitaliano Aguirre II ordered the National Bureau of Investigation (NBI) on Monday to investigate the P3.5-billion dengue vaccination program of the DOH that put the lives of more than 733,000 public school children at risk.

Aguirre issued Department Order No. 763, tasking the NBI to investigate and build a case against those responsible for supposedly placing public health in danger.

The dengue vaccination program began during the term of then-Health Secretary Janette Garin in April 2016.

DOH said that more than 733,000 children — aged 9 and above — from public schools in Metro Manila, Central Luzon, and Calabarzon have already received at least the first three doses of the vaccine.

The agency has put on hold the government's dengue vaccination program after Sanofi raised health concerns on the vaccine.

French-based pharmaceutical company Sanofi Pasteur Philippines on Monday clarified that the dengue vaccine Dengvaxia does not cause severe dengue, but a subsequent exposure to the virus may cause it.

The company said it will cooperate with the National Bureau of Investigation in its probe of the P3.5-billion dengue vaccination program of the DOH. —KG, GMA News

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