Manila Bulletin

DOH asks Sanofi to refund 11.4-billion for unused Dengvaxia

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The Department of Health (DOH) yesterday asked Sanofi Pasteur to refund some P1.4 billion of unused Dengvaxia vaccine and shoulder the testing of the more than 830,000 children who were vaccinated with the controvers­ial drug.

In a letter sent to Thomas

Triomphe, head of Sanofi Pasteur Asia Pacific, the DOH laid down its demand for Sanofi the refund of 11.4 billion which correspond­s to the remaining unused vials of Dengvaxia.

Moreover, in a separate letter, the health department requested the company to conduct serotestin­g of those vaccinated using a newly developed test to determine their pre-vaccinatio­n status at no cost to the government.

The DOH also requested 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.

"The risk benefit ratio of Dengvaxia has significan­tly changed as the risk caused by the introducti­on of the vaccine to seronegati­ve people has greatly outweighed its benefits, if any,” Health Secretary Francisco Duque III said.

“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,” he added.

Duque said the DOH has yet to receive an official response from Sanofi Pasteur on the demand letters.

Dengue shock

Meanwhile, Duque disclosed that based on official data from Epidemiolo­gy Bureau, four out of 17 deaths following the immunizati­on of Dengvaxia were found to have died due to dengue shock.

“Based on the Dengvaxia Surveillan­ce Update on January 10, 2018 from the Epidemiolo­gy Bureau, four of the 17 cases being looked into identify dengue shock as cause of death,” he said.

Other deaths, on the other hand, were among children who had other illnesses and comorbidit­ies.

The DOH chief also emphasized that there is no conclusion yet on whether the administra­tion of Dengvaxia caused the death of the children who had been vaccinated.

“We cannot answer that as of now because our experts are still studying the clinical records,” Duque explained.

A panel of UP-PGH independen­t experts are currently evaluating the clinical records of these cases.

In November, Sanofi said that Dengvaxia could worsen symptoms in people who never had the disease. (Charina Clarisse L. Echaluce)

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