Philippines halts sale of dengue vaccine as Sanofi downplays risk


A statement from Sanofi said the long-term trial results highlighted "the complex nature" of dengue infection as it proposed a "label update" on the use of the vaccine.

The Philippine Department of Health put on hold its 3.5 billion peso ($69.5 million) public dengue immunisation drive launched past year - the world's first such public programme - after the study was released last week.

Sanofi officials reported that there were no deaths reported due to the vaccine in the Philippines.

The WHO, which issued a report identifying the vaccine's safety risk in mid-2016, recommended it only be used in people who had prior dengue infection.

French pharmaceutical giant Sanofi Pasteur admitted last week that clinical data showed Dengvaxia - the first licensed dengue vaccine - could make the disease worse in people who had not previously been infected with the virus. No cases in the most severe level were recorded, and all those stricken with dengue in the study have fully recovered, she said. Most sales have come from the Philippines through its government immunization program involving more than 730,000 children, and Brazil, where the state of Parana has seen a three-fold increase in dengue in the past few years.

To allay the fears of the public, Malacañang on Monday reminded the public to not panic over the government's dengue vaccination program, saying the Department of Justice (DOJ) will start an inquiry on the purchase of the drug.

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As of November 2017, about 733,713 Filipino children have been given the anti-dengue vaccine.

Sanofi spent $1.8 billion over more than 20 years to prep this launch, expecting to develop a new franchise worth $1.5 billion a year.

Health Assistant Secretary and infectious disease specialist Lyndon Lee Suy said they will continuously monitor the condition of Filipino recipients who already received doses of the vaccine.

The Food and Drug Administration (FDA) called on the public to partake in the "post-marketing surveillance of Dengvaxia" by reporting any incident that shows the dengue vaccine has led to death, serious illness, or injury of a patient.

Dengue is a mosquito-borne viral infection found in tropical and subtropical climates worldwide.