Sanofi sued in Philippines over dengue vaccine

February 7, 2018

A Philippine government agency has recently filed a lawsuit against French drugmaker Sanofi demanding compensation for the parents of a 10-year-old girl the agency said had died as a result of receiving its controversial anti-dengue vaccine.

The Public Attorney’s Office (PAO) said Sanofi, several former and current health ministry officials and domestic distributor Zuellig Pharma Corp must be declared jointly liable for the death of Anjielica Pestilos.

Pestilos was one of the more than 800,000 Filipino children aged nine and above who had been inoculated with Dengvaxia.

The agency is seeking compensation of up to 4.2 million pesos (US$81,600) over her death. PAO said Pestilos should not have been given the vaccine because a forensic examination showed she had a pre-existing disease.

“So much bleeding from her lungs, her liver, her heart, her stomach were from viscerotropic-like disease which was caused by the injection of Dengvaxia,” PAO forensic expert Erwin Erfe told a news conference, explaining what he said was the underlying cause of her death.

But Sanofi said it knew of no deaths resulting from the vaccine.

“In Dengvaxia clinical trials conducted over more than a decade and over one million doses of the vaccine administered, no deaths causally related to the vaccine have been reported to us,” it said in a statement.

Sanofi also rejected a Department of Health (DOH) request to refund the government for used doses of the vaccine, which it said would “imply that the vaccine is ineffective, which is not the case”.

Health Secretary Francisco Duque said the Dengvaxia controversy had “tainted the credibility” of the country’s immunization program.

Two non-government organizations filed an administrative complaint with the Office of the President on Monday calling for 13 health ministry officials involved in the anti-dengue program to be dismissed.

The DOH suspended its dengue immunization program following a Sanofi advisory late in November that said the vaccine itself may, in some cases, increase the risk of severe dengue in recipients not previously infected by the virus.

Just recently, a panel of experts tasked by the DOH to determine if the drug was directly connected to the deaths of 14 recipients of the vaccine found it may have been connected to three deaths. It concluded Dengvaxia was not ready for mass immunization.

Mosquito-borne dengue is the world’s fastest-growing infectious disease, afflicting up to 100 million people worldwide, causing half a million life-threatening infections and killing about 20,000 people, mostly children, each year.

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