THE government intends to sue Sanofi after officials suspended the pharmaceutical giant’s anti-dengue vaccine and began investigating reports that some children had died after receiving Dengvaxia shots.
Regulators froze the world’s first public dengue immunization program last week and suspended all sales of the vaccine on Monday after Sanofi said Dengvaxia could worsen symptoms for vaccinated people who contracted the disease for the first time.
“Eventually it’s the court of law that is going to decide insofar as the liability of Sanofi is concerned,” Health Secretary Francisco Duque said in a TV interview.
Duque also said the Health Department was investigating reports of deaths, but did not name 10-year-old Christine Mae de Guzman in Mariveles, Bataan, who died allegedly due to severe dengue six months after being given the Dengvaxia vaccine.
“This is subject to validation… I have yet to see the full documents,” Duque said, referring to the reported deaths.
Duque, who said Sanofi’s statements on Dengvaxia were “confusing,” said he had talked to Bataan Rep. Joet Garcia, who had informed him of the reported deaths.
However, Duque noted that health officials said these might have been caused by pre-existing conditions.
De Guzman’s parents told the Volunteers Against Crime and Corruption that their daughter had no prior dengue history when Sisiman Elementary School gave her the dengue vaccine on April 6, 2016.
Nelson, the father of De Guzman, a Grade 5 student, said they sought the help of the VACC, which has asked the Justice Department to examine the bodies of three children believed to have died after being given Dengvaxia shots.
He said those resposible for the death of their daughter should be held liable.
The previous administration of President Benigno Aquino launched the P3.5-billion vaccination program last year, making the Philippines the first nation to use Dengvaxia on a mass scale.
About 830,000 schoolchildren had received at least one dose of the vaccine, Duque said on Thursday. Previously the government said more than 733,000 people had been vaccinated.
The announcement last week caused great concern, particularly among the parents of those vaccinated.
The French company on Monday sought to allay concerns, saying Dengvaxia would not cause anyone who was immunized to die and would not cause a dengue infection.
Duque said he may ask Sanofi to refund P1.4 billion ($27.6 million) worth of unused Dengvaxia supplies.
He added the government might also demand Sanofi set up an “indemnity fund” to cover the hospitalization cost for children vaccinated under the public program who would fall ill.
Sanofi was not immediately available to comment on Duque’s remarks.
Asked if the government would sue Sanofi if allegations of a lack of transparency were proved, Duque said: “I’m sure it’s going to get there.”
He added: “If it’s found out that (Sanofi) withheld material information that would have changed the outcome of all of these problems and the decision makers of the Department of Health in the previous administration, then they are liable.”
Duque said congressional hearings into the issue would start next week.
In another radio interview, Duque said he received a report from a hospital in Pampanga that a child, whom he did not name, had received the required three shots of the vaccine in March and October 2016 and in August 2017, but still got dengue. The child was confined at the JB Lingad Hospital in Pampanga and has since recovered.
Duque said Sanofi had assured them that the vaccine would provide protection from dengue for at least 30 months, but they were seeing cases where infections developed as early as 20 months.
The Health secretary said Aquino should shed light on the vaccine mess.
“I think the former President should himself come forward and as this is what happened and this is what I agreed to based on some recommendation that I followed because somebody had advised me,” Duque told the ANC news channel.
Aquino met with executives of pharmaceutical giant Sanofi Pasteur, who paid him a courtesy call in Paris on Dec. 1, 2015. A few weeks after the meeting, the Philippines became the first Asian country to approve the commercial sale of Dengvaxia.
Aquino approved the vaccination program, which started in April 2016, with free vaccination of children 9 years and older, from public schools in Metro Manila, Central Luzon and the Calabarzon region.
Aquino and former Health secretary Janette Garin reportedly approved the P3.5-billion program without certification from the World Health Organization.
In Thursday’s regular “Kapihan sa Senado,” Senator JV Ejercito, chairman of the Senate committee on health and demography, said they would hold an inquiry into the vaccination program in January 2018.
The Justice Department earlier said it would open its own investigation, which would also look at the possible liability of Aquino and Garin.
In a statement released earlier this week, WHO said that their position paper did not include a recommendation to countries to introduce the dengue vaccine into their immunization programs.
“Rather, WHO outlined a series of considerations national governments should take into account in deciding whether to introduce the vaccine, based on a review of available data at the time, along with possible risks,” the WHO said.
Senator Grace Poe called on health officials to closely monitor children who have received the anti-dengue vaccine.
“It is important to account for children who received the vaccine amid new developments on its effects. Strict surveillance must be established to monitor any adverse effects and ensure that proper assistance will be given to those affected,” Poe said.
Poe also filed a resolution calling for a full-blown Senate inquiry into why the inoculation program was hastily approved even though the vaccine was still undergoing trials.
Poe said the government should be ready to create a comprehensive database of people who have been injected with Dengvaxia, including those who have not been infected and those who have had prior exposure, and determine any adverse effects following the immunization.
“We also seek the assistance of local government units in disseminating information coming from the DOH and other government agencies. If any of these initiatives would entail costs, the government should be ready with the funds and resources because at stake here are the lives of our children,” Poe said.
Senator Leila de Lima, detained on drug charges, said the press conference of Justice Secretary Vitaliano Aguirre II, Jimenez and lawyer Ferdie Topacio, was a lesson on how not to manage a public health crisis.
“Citing nothing but anecdotal data and malicious speculation on the effects of the vaccine, the alarmist tact of these three stooges managed nothing but sow panic among the public. What is funny about this presscon is that not one public health expert or DOH official was present to corroborate the scientific reliability of the anecdotal data of these clowns,” De Lima said.
De Lima, Justice secretary in the Aquino administration that approved the vaccine program, said Aguirre’s statements were “irresponsible, alarmist, speculative and even malicious.”
The VACC has said it is studying the culpability and involvement of Garin, Aquino and other DOH officials who approved the P3.5-billion procurement of Dengvaxia.
“Someone must be held liable for the mass vaccination of over 733,000 children who received the Dengvaxia shots,” Jimenez told the Manila Standard.”I am pretty sure the people would storm the Aquinos once the truth comes out.”
“Can you imagine how many children are now at risk?”
He said other allies of the past administration inside the Health Department are trying to cover up the corruption during the procurement of the vaccines.
“We will all know once the Senate investigation starts,” he said.
He said their lawyers are studying the possibility of filing a class suit. With Rio N. Araja