By Charina Clarisse Echaluce

Multinational pharmaceutical giant Sanofi Pasteur, manufacturer of the controversial dengue vaccine Dengvaxia, was asked by the Department of Health (DOH) to refund the over P1.4-B unused Dengvaxia and shoulder the testing of the more than 830,000 vaccinated children.

In a letter sent to Thomas Triomphe, head of Sanofi Pasteur Asia Pacific, the DOH laid down its demand for Sanofi to refund in the amount of P1.4 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 the vaccinees using a newly developed test to determine their pre-vaccination status at no cost to the government.

The DOH, as well, 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.

On November 29, 2017, the Sanofi Pasteur announced a “new finding” on its vaccine Dengvaxia, which was used in the government’s mass immunization program.

“The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection…. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection,” Sanofi said in a previous statement.

On December 1, 2017, Duque put on hold the government vaccination drive.

‘4 of 17 succumbed to dengue shock’

Duque disclosed that based on official data from Epidemiology Bureau, four out of the 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 vaccinees.

“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.