Senate invites Aquino to vaccine probe

MANILA, Philippines — Former president Benigno Aquino III has been invited to appear at the next Senate hearing on Thursday into his controversial dengue vaccination program, which reportedly has put the lives of tens of thousands of children at risk.

Aquino’s camp told The STAR he received the invitation for him to attend the probe yesterday afternoon at his Quezon City home, but did not say whether he would attend Thursday’s hearing.

The joint inquiry of the Senate Blue Ribbon and health committees is looking into the possible irregularities in the implementation of the Aquino administration’s P3.5-billion dengue vaccination program.

During the last hearing on Monday, senators questioned the haste by which Aquino ordered the realignment of P3.5 billion from the budget for purchase of some three million doses of Dengvaxia vaccine from Sanofi Pasteur late in 2015.

The purchase of the vaccines, which Sanofi later warned could trigger severe illness under certain circumstances, was not originally listed in the budget, and the doses were delivered and injected just several weeks before the presidential elections in May last year.

Sen. Richard Gordon, chairman of the Blue Ribbon panel, said some wrongdoing “definitely happened” in the program, pointing out it was unusual for a president to meet twice with mid-level Sanofi executives that was followed by the swift listing of Dengvaxia in the national formulary and approved by the Food and Drug Administration in just a few months.

When asked who should be held accountable for any wrongdoing, Gordon said: “From the beginning, every one who endorsed (the program).”

“Not just from (former health secretary Janette Garin), you go higher to the (Department of Budget and Management), then up to the president (Aquino). There’s a conspiracy. It’s very clear that the fund release was rushed,” Gordon said.

Despite admitting that Dengvaxia could trigger serious complications, Sanofi executives maintained that their vaccine remains safe and “efficacious.”

Thomas Triomphe, Sanofi vice president and head of its Asia-Pacific division, stressed that Dengvaxia was a result of over 20 years of rigorous research and development involving more than 40,000 individuals in 15 countries.

Triomphe said there has been no reported death of any person linked to the vaccine, adding Sanofi Pasteur continues to monitor all vaccinations not only in the Philippines but also in other countries where Dengvaxia is used.

Palace on wait and see

President Duterte has taken a wait and see attitude on the ongoing investigation at the Senate into the procurement of Dengvaxia that was authorized by then president Aquino.

Presidential spokesman Harry Roque said the President is distancing himself from the issue while the Department of Justice (DOJ) and the Senate are conducting their respective probes.

“The President has promised that after investigations have been conducted both by the Senate and the (DOJ), he will run after all individuals who may have criminal culpability for this,” Roque added.

Duterte is supportive of the move of the Department of Health (DOH) to hold Sanofi responsible, Roque said.

“We want, by way of a minimum, a refund of what we have paid already for Dengvaxia,” he said.

Roque said the President supports the call for refund of the P 3.5 billion, which was realigned for the DOH’s dengue vaccination program, starting in April last year.

House resumes probe

It is the turn of the House of Representatives to resume its inquiry into the procurement and use of Dengvaxia.

The committees on good government and public accountability, and health have invited former and incumbent health officials led by Secretary Franciso Duque lll and representatives of Sanofi.

The French pharmaceutical giant has admitted that its vaccine is safe on children who had prior dengue infection but would have complications on those who had not been infected with dengue before vaccination.

Over the weekend, Surigao del Sur Rep. Johnny Pimentel, who heads the good government committee, said Sanofi could be held responsible for “misrepresenting” the safety and efficacy of its product.

Quezon Rep. Angelita Tan, who chairs the committee on health, said Sanofi had not issued any risk warning about Dengvaxia when they held hearings in the latter part of last year and early this year.

“What they told us in our hearings was that Dengvaxia was safe and efficacious. Sanofi did not tell us that it was still conducting clinical test or evaluating test results,” she said.

She said Sanofi and DOH officials insisted on the efficacy and safety of the newly developed vaccine despite reservations expressed by one resource person, clinical epidemiologist Antonio Dans of the Philippine College of Physicians.

The draft report of the committee on health on its inquiry quoted Sanofi regional director physician Ann Wartel as telling the panel that the World Health Organization  (WHO) had recommended the use of Dengvaxia in areas with high dengue incident.

“To further support her claim on the vaccine’s efficacy and safety, Wartel apprised the body that more than 40,000 people were involved in the clinical trials in 25 studies across 15 countries worldwide. Among those involved in clinical trials, 29,000 are children, adolescents and adults who have received the vaccine and had no record of death,” it said.

The report said even physician Ma. Rosario Capeding, head of microbiology of the DOH Research Institute for Tropical Medicine, vouched for the safety and efficacy of Dengvaxia.  

‘Dengvaxia fast lane’

Rural health centers will establish a fast lane for students who exhibit signs of dengue after receiving the vaccine Dengvaxia, the Department of Education (DepEd) said.

Education Secretary Leonor Briones issued a memorandum directing school officials in areas where the vaccination program was implemented to monitor the condition of school children who received the anti-dengue vaccine.

She said each school in areas where the program was implemented will be matched with a Rural Health Unit (RHU) where a referral or fast lane will be created.

In her memorandum, the DepEd chief told officials to review the master list of students who received the vaccine and flag them for monitoring for any symptoms of fever and initiate the referral report when necessary.

Among the areas where Dengvaxia vaccination programs were implemented include Metro Manila, Cebu Province, and Regions III and IV-A.

“Other regions which did not implement the school-based dengue vaccine program are likewise advised to conduct an assessment among nine-year-old learners and above of Grades 4 to 6, who might have been vaccinated by private practitioners and the community based vaccination,” said Briones.

The education chief also reminded schools nationwide to conduct activities that prevent the spread of dengue-carrying mosquitoes.

Protect the youth

Meanwhile, National Youth Commission (NYC) chair Aiza Seguerra yesterday urged government agencies to look into the welfare of children who received the vaccine.

Seguerra said while they support current investigations to identify who must be held liable for the vaccination program, there should be parallel moves and strategies to find out how each child is coping with the vaccine.

“We all believe that local authorities should enjoin the help of volunteers and other concerned sectors in monitoring the status of the vaccinated children. This will help the health authorities in assessing the extent of potential risks or hazards that are identified with the vaccine,” said the NYC chair.

Local exec plans suit

League of Cities of the Philippines president Angeles City Mayor Edgardo Pamintuan has met with a legal team from France and the EU for actions that could be taken against Sanofi.

In a statement, Pamintuan expressed outrage amid the death of two children from severe dengue who had been vaccinated in Tarlac and Bataan.

Pamintuan declined to reveal the result of his meeting with the foreign lawyers, except that they have formed a team to decide on their actions against Sanofi.

An estimated 733,000 students in Central Luzon, Batangas, Cavite, Laguna, Quezon, Rizal and Metro Manila were injected with the vaccine. 

Pamintuan said he has instructed the city health office to monitor the children who had been immunized. 

In Mabalacat City, nine pupils at the Lakandula Elementary School were reported to have fallen ill with fever last week after they had been vaccinated with Dengvaxia a few months ago.  

Amid the scare created by Dengvaxia, the Philippine Society for Microbiology and Infectious Disease Inc. (PSMID) yesterday urged the public to keep a tight watch for dengue symptoms to prevent complications and deaths.

In a health forum organized by the Philippine College of Physicians, PSMID board director Fatima Gimenez said parents should not dilly-dally if their children are showing any signs of dengue.

She noted that most of dengue patients who progress into shock or death are those who were brought to doctors too late. 

“The kids are brought to you at a time when they are already having a shock. Dengue does not usually require hospitalization because if it primarily fluid management to prevent dehydration,” Gimenez added.   

Citing the 2009 definition of WHO of severe dengue, PSMID president Mario Panaligan said the warning signs of the mosquito-borne disease include vomiting, abdominal pain, rashes, fever and lowering platelet count.

The Philippine Medical Association (PMA) believes the DOH had rushed the inclusion of Dengvaxia in its anti-dengue campaign.

In an interview, PMA president Irineo Bernardo III said before using Dengvaxia, the DOH should have established a baseline of the vaccinated school children for comparison. – Christina Mendez, Janvic Mateo, Jess Diaz, Ding Cervantes, Ric Sapnu, Sheila Crisostomo