Philippines medical officials announced Friday they have made its demands official against Dengvaxia manufacturer Sanofi Pasteur.
Inside a letter delivered to Thomas Triomphe, mind of Sanofi Pasteur Asia Off-shore, the DOH set its interest in Sanofi to refund in the quantity of Php1.4 billion (roughly $28 million) which matches the rest of the unused vials of Dengvaxia.
The DOH has additionally another letter requesting Sanofi Pasteur to conduct serotesting from the greater than 830,000 vaccinees utilizing a recently developed test to find out their pre-vaccination status free of charge towards the government.
The DOH also requested documents on all of the ongoing numerous studies along with other studies involving Dengvaxia within the Philippines, including proof they have passed ethics review standards from the Philippine Council for Health Development and research (PCHRD)
Secretary Duque disclosed the DOH has yet to get the official response from Sanofi Pasteur around the demand letters.
The department has stopped its dengue vaccination program after Sanofi Pasteur released an advisory on Dengvaxia, which signifies danger to individuals who haven’t been uncovered to dengue just before immunization.
“The risk benefit ratio of Dengvaxia has considerably altered because the risk brought on by the development of the vaccine to seronegative people has greatly outweighed its benefits, or no,” Duque described.
“The Dengvaxia vaccine which Sanofi Pasteur strongly promoted and offered towards the Philippine Government has undeniably unsuccessful to provide its supposed clinical benefit and safety claims, hence, considered defective under Philippine civil laws and regulations,” he added.
Secretary Duque clarifies that according to official data from Epidemiology Bureau, four from 17 deaths following a immunization of Dengvaxia put together to possess died because of dengue shock. Other deaths were among children who’d other illnesses and comorbidities.
“Based around the Dengvaxia Surveillance Update on The month of january 10, 2018 in the Epidemiology Bureau, four from the 17 cases being investigated identify dengue shock as reason for dying,” Duque stated.
The DOH also emphasizes that there’s no conclusion yet on if the administration of Dengvaxia caused the dying from the vaccinees. A panel of PGH independent experts are presently evaluating the clinical records of those cases.
“We cannot answer that as of this moment because our experts continue to be staring at the clinical records,” Duque described.
The DOH reiterates its earlier statement that it’s prepared to cooperate with ongoing investigations being conducted through the Department of Justice (DOJ) and also the Public Attorney’s Office (PAO).
“We welcome these investigations as complementary to the efforts to find the reality regarding this trouble,” Duque stated.
Meanwhile, the DOH, upon orders from the Top Court, is preparing its discuss the petition for mandamus advocating the DOH other government departments to supply free medical services and treatment to vaccinees.