DOH to Sanofi: Test all 837,000 vaccinated kids
While still verifying if Dengvaxia caused the deaths from dengue shock of several children who had been vaccinated with the drug, the Department of Health (DOH) wants the manufacturer to conduct tests on the children who have received the vaccine.
The DOH has officially demanded that pharmaceutical firm Sanofi Pasteur conduct serotesting of about 837,000 school children injected with its controversial Dengvaxia vaccine to determine their “pre-vaccination status.”
Health Secretary Francisco Duque III said he sent a letter to Sanofi Pasteur head for Asia Pacific Thomas Triomphe for the company to do the serotesting using a newly developed test “at no cost to the government” to establish if the children already had a history of dengue prior to their vaccination.
In another letter, Duque demanded that Sanofi should refund the DOH P1.4 billion, the cost of the remaining unused vials of Dengvaxia.
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.
Duque said the DOH has not yet received an official response from Sanofi on the letters he sent.
Over 830,000 children from public schools in the National Capital Region, Central Luzon, Calabarzon and some parts of Cebu were given Dengvaxia under the DOH’s dengue immunization program since 2016.
The DOH has stopped its dengue vaccination program after Sanofi released an advisory on Nov. 29, 2017 indicating the potential risk of Dengvaxia 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 said.
“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.
PAO insists on Dengvaxia link
The forensics team of the Public Attorneys Office yesterday said that there is a strong link between Dengvaxia and the deaths of the seven children whose remains the team has examined. Dr. Erwin Erfe, director of the PAO Forensic Laboratory, said a “pattern” has consistently emerged in the seven examinations they conducted upon the request of the families. The common findings were extensive organ bleeding, enlarged organs and rapidly fatal progression of diseases on the children’s bodies. “What is clear at this time is, there is a strong link between Dengvaxia and the deaths of the children. There is pattern that is similar across the seven,” he said in a phone interview.
Of the seven children, two were girls and five were boys, all injected with Dengvaxia.
Except for the 11-year-old girl from Mariveles, Bataan who died around eight months after vaccination, six out of the seven children examined died less than six months after vaccination.
The girl, whose death was attributed to Dengue Shock System, was the seventh body examined by the PAO team on Thursday.
The girl died within 24 hours of confinement after she was diagnosed with Dengue. Erfe said the PAO forensics team saw signs of bleeding in different organs.
The forensics team also examined the exhumed body of an 11-year-old boy from Bagac, Bataan. He was an athlete, but died 11 days after vaccination.
Erfe said the boy supposedly had congenital heart disease and fell ill two days after he was rushed to the hospital due to fever and body weakness.
The boy’s already skeletonized body also showed staining at the scalp area of the skull, which Erfe said could have been caused by accumulation of blood.
The first body that PAO examined was a 10-year-old girl in December, followed by four more boys from San Pablo in Laguna, Imus in Cavite, Vicente Cruz in Manila and Balanga and Bagac in Bataan prior to the examination of the young girl from Mariveles.
“It is out of the norm. Very surprising because the findings are the same and they were all recipients of Dengvaxia with their ages in the same range and different locations,” Erfe said.
DOH: No conclusion yet
As to the investigation of the DOH, Duque said that based on official data from the Epidemiology Bureau, four out of 17 deaths following the immunization of Dengvaxia were found to have been due to “dengue shock.” Other deaths were among children who had other illnesses and co-morbidities.
But Duque underscored that there is no conclusion yet on whether the administration of Dengvaxia caused the death of the vaccinees. Currently, a panel of independent experts from the Philippine General Hospital is investigating and evaluating the clinical records of these cases.