Philippines health officials announced Friday that they have made its demands official against Dengvaxia manufacturer Sanofi Pasteur.
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 Php1.4 billion (approximately $28 million) which corresponds to the remaining unused vials of Dengvaxia.
The DOH has also another letter requesting 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 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 (PCHRD)
Secretary Duque disclosed that the DOH has yet to receive an official response from Sanofi Pasteur on the demand letters.
The department has halted its dengue vaccination program after Sanofi Pasteur released an advisory on Dengvaxia, which indicates potential risk to those who have not been exposed to dengue prior to immunization.
“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,” Duque explained.
“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.
Secretary Duque clarifies 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. Other deaths were among children who had other illnesses and comorbidities.
“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,” Duque said.
The DOH also emphasizes that there is no conclusion yet on whether the administration of Dengvaxia caused the death of the vaccinees. A panel of PGH independent experts are 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.
The DOH reiterates its earlier statement that it is willing to cooperate with ongoing investigations being conducted by the Department of Justice (DOJ) and the Public Attorney’s Office (PAO).
“We welcome these investigations as complementary to our efforts in finding the truth about this matter,” Duque said.
Meanwhile, the DOH, upon orders of the Supreme Court, is preparing its comment on the petition for mandamus urging the DOH other government agencies to provide free medical services and treatment to vaccinees.
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