The Department of Health (DoH) on Friday demanded a P1.4-billion refund from Sanofi Pasteur for its stock of anti-dengue vaccines, and asked the French pharmaceutical giant to pay for testing on inoculated individuals.
The Health department made the demand in a letter to Sanofi Pasteur Asia-Pacific head Thomas Triomphe, for all unused vials of anti-dengue vaccine Dengvaxia worth P1.4 billion or $27.8 million.
In another letter, the DoH told Sanofi it should conduct the “serotesting” of more than 830,000 individuals inoculated with the vaccine using a newly developed test to determine their pre-vaccination status, at no cost to the Philippine government.
The DoH also requested documents on all clinical trials and other studies involving Dengvaxia in the Philippines, including proof that these have passed ethics review standards of the Philippine Council for Health Research and Development.
Sanofi has yet to answer the Health department, Secretary Francisco Duque 3rd 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,” Duque said.
Earlier, Duque said that based on official data from the Epidemiology Bureau, there were four cases out of 17 deaths due to “dengue shock.”
Other cases of deaths of children were due to other illnesses or other complications.
However, Duque said there was still no conclusion yet on whether or not the inoculation of Dengvaxia caused any deaths.
An expert panel from the University of the Philippines and Philippine General Hospital is still evaluating the clinical records of the cases.
The DoH reiterated that it was willing to cooperate with the investigation being conducted by the Department of Justice and the Public Attorney’s Office, and would comment on the petition for mandamus before the Supreme Court, asking it and other government agencies to provide free medical services to the vaccinees.
Sanofi has been in hot water after admitting that the anti-dengue vaccine, administered on about 830,000 individuals, may cause a more severe case of dengue for first-time patients.
The Department of Health last month suspended the dengue immunization program based on an advisory of Sanofi. The FDA ordered the recall of the medicine the same month.
The government spent P3.5 billion or around $70.2 million for the immunization program, which began during the time of Health Secretary Janette Garin in the Aquino administration.
Leonen to handle petition vs Dengvaxia
The Supreme Court has assigned a magistrate who will be in charge of a petition of the Gabriela party-list group to compel officials from the Executive department to provide free medical services and treatment to children injected with the controversial anti-dengue Dengvaxia vaccine.
The case was assigned to Justice Marvic Leonen after a raffle conducted by the high court.
Leonen was an appointee of President Benigno Aquino 3rd, who has since been dragged into the controversy over his administration’s approval of the procurement of the vaccine.
Then-Health Secretary Garin said she had talked with executives of Sanofi, maker of the Dengvaxia vaccine.
In a 42-page petition for mandamus, the court was asked by Gabriela Rep. Emmi de Jesus and the Association for the Rights of Children in Southeast Asia to direct government agencies to publicly disseminate on a regular basis the report of a task force formed and designated to monitor and review the school-based immunization program involving Dengvaxia and submit the same to the House of Representatives and Senate Committees on Health for monitoring.
Named respondents to the case are Duque; Interior Acting Secretary Catalino Cuy; Education Secretary Leonor Briones; Lyndon Lee Suy, National Center for Disease Prevention and Control program director; and Nela Puno, Food and Drug Administration director general.
The petitioners also asked that the government monitor children who were inoculated with the vaccine across the country.
The petitioners also asked that government agencies provide free services including, but not limited to, medical check-ups, consultations, medical treatment and blood tests.
“There are reports that the [Health department] will provide monetary compensation to those who were inoculated with Dengvaxia. However, petitioners maintain their position that monetary rewards are not enough to compensate for the injury brought to them by this medical scandal,” the petition also stated.
with JOMAR CANLAS