DOH asks Sanofi to refund P1.4-B unused Dengvaxia


Posted at Jan 12 2018 05:48 PM

MANILA - The Department of Health (DOH) on Friday said it has officially asked drug manufacturer Sanofi Pasteur for a refund of the remaining unused vials of Dengvaxia and to shoulder the cost of tests for the vaccine's recipients.

The DOH said it has sent a letter to Thomas Triomphe, head of Sanofi Pasteur Asia Pacific, conveying these demands, but has not yet received an official response.
"The Dengvaxia vaccine which Sanofi Pasteur aggressively promoted and sold to the Philippine Government has undeniably failed to deliver its supposed clinical benefit and safety claims, hence, considered defective under Philippine civil laws," said Health Secretary Francisco Duque.
The DOH said it asked for Php1.4 billion from the French firm, corresponding to the remaining unused vials of Dengvaxia, which Sanofi Pasteur has admitted might cause more severe dengue symptoms if given to those who have not had the mosquito-borne disease before.
The DOH said it also requested Sanofi Pasteur to conduct "serotesting of the more than 830,000 vaccinees using a newly developed test to determine their pre-vaccination status at no cost to the government."
The DOH also asked for documents on all the ongoing clinical trials and other studies involving Dengvaxia in the Philippines, including proof that they have passed ethics review standards of the Philippine Council for Health Research and Development, it said in a press release.

Sanofi's admission late last year on the vaccine's health risks prompted Philippine authorities to suspend the sale of Dengvaxia. The government also suspended its nationwide dengue immunization program, under which some 830,000 children were injected with the drug.

It also prompted lawmakers to launch a legislative inquiry into the matter.

Earlier this month, the Public Attorney's Office said it had examined the bodies of 4 children who died after receiving the drug and discovered the following pattern: internal bleeding, enlarged organs and death within 6 months after the injection. 

Duque, in a DOH report, said official data from Epidemiology Bureau states that 4 out of 17 deaths following the immunization of Dengvaxia were found to have died due to dengue shock. Other deaths were among children who had other illnesses and comorbidities.
However, there is no conclusion yet on whether the administration of Dengvaxia caused the death of the vaccinees, and a panel of experts from the Philippine General Hospital is currently evaluating the clinical records of these cases.
"We cannot answer that as of now because our experts are still studying the clinical records," Duque explained.