The manufacturer of the controversial Dengvaxia vaccine has refunded P1.2 billion worth of unused anti-dengue vaccines, Health Secretary Francisco Duque III said yesterday.

In a summit attended by local officials and health workers from all over the province, Duque announced that Sanofi Pasteur issued a check as refund for the unused vials of Dengvaxia on Thursday.

The amount will be reverted to the national treasury. Duque hopes the DOH will be allowed to use the fund to help the victims of Dengvaxia and other programs of DOH.

He assured the parents of the 800,000 children vaccinated with Dengvaxia that PhilHealth will cover the cost of their hospitalization.

Pampanga Gov. Lilia Pineda ordered all 11 district hospitals in the province to implement a “zero balance hospital bill” for all dengue patients, even those not given Dengvaxia shots.

The previous administration allocated P3.5 billion for the massive anti-dengue vaccination program of the Department of Health (DOH), and Sanofi is deciding if the pharmaceutical firm will refund the whole amount.

“I was told that the matter of refunding the entire amount allocated by the government for the anti-dengue immunization program is being tackled at the highest levels of the firm,” Duque said.

Aquino likely got ‘ill advice’

Duque also vowed that he would “surely hold accountable” those who withheld any data on Dengvaxia, which could have convinced the Aquino administration not to push through with the massive anti-dengue vaccination program.

The DOH is finding out who were the persons involved in deciding to implement a massive Dengvaxia vaccination drive affecting some 800,000 students of public schools in Central Luzon, National Capital Region and Calabarzon.

Duque said former president Benigno Aquino III could have been “ill-advised” when he allowed the dengue vaccination program to proceed.

He pointed out that Dengvaxia was not only new, but targeting one million children for vaccination was also too much.

“For me, as secretary of health, it is better to err on the side of caution, especially since children are involved here. It’s the health and welfare of children that are at stake,” he added.

‘Vaccination must remain suspended’

Health Undersecretary Eric Domingo said the panel of experts from the Philippine General Hospital (PGH), which the DOH created to look into the scientific aspects of the Dengvaxia controversy, forwarded to Duque yesterday its initial findings and recommendations.

Domingo said the panel came up with a three-page summary of its discussions and recommendations after looking into the cases of 14 vaccinated children who died after being given Dengvaxia vaccines.

The PGH panel has recommended to the DOH not to resume the dengue immunization program.

Domingo said the panel recommended that “as a precautionary measure, the Dengvaxia mass immunization program should remain suspended at this time.”

The panel could not also give a “firm recommendation” to complete the schedule of the vaccination “in view of the sparse information from the clinical trials on the consequences of administration of less than three doses of Dengvaxia.”

“However, for children with incomplete doses who had been confirmed to have had dengue before Dengvaxia vaccination, completion of doses may be protective,” the summary read.

On the safety and efficacy of the vaccine, the panel found that “Dengvaxia may pose an increased risk of dengue (hospitalized and severe virologically confirmed dengue) among seronegative individuals, regardless of age.”

The panel also reported that the sample size involving the “sub-cohort of seronegative children was too small to demonstrate a statistically significant increase, but the direction and trend towards harm is cause for serious concern.”

Duque said the DOH executive committee will look into the recommendations and see which of these are doable.

He also said the panel’s recommendation to complete the vaccination of selected recipients is faced with an “intervening event, which was the Food and Drug Administration’s action to suspend the product registration” of Dengvaxia.

The PGH panel also recommended full assistance to vaccinated kids who would fall ill to dengue, as well as compensating the families of the vaccinated children.

Vaccine failure

Duque said he was just waiting for more evidence before deciding if there was a “vaccine failure.”

Health experts will be reviewing thoroughly the recommendations of the PGH panel along with other parallel investigations.

Currently, the Public Attorney’s Office is also investigating the Dengvaxia mess by doing autopsy on vaccinated children to determine if the deaths are connected to the vaccine.

Sen. JV Ejercito, chair of the Senate committee on health, said his panel has scheduled the next hearing on Dengvaxia on Monday.

He admitted that he is concerned because his 17-year-old son was also vaccinated with Dengvaxia.

“We have to address the anxiety, the uncertainty of the future of these children, the anxiety of the parents. We would concentrate on the health aspect this time,” he said