Noy on vaccine: We wanted to save lives

MANILA, Philippines — They were presented with an opportunity to save lives, and they took it.

Former president Benigno Aquino III defended yesterday his administration’s decision to implement a P3.5-billion dengue vaccination program in 2016, saying he wanted to save lives and all the requisite processes were followed before the Dengvaxia vaccine was administered to people aged nine years and older.

Testifying for the first time in the Senate inquiry into the Dengvaxia controversy that lasted for six-and-a-half hours, Aquino said he made the decision based on available data presented to him and that nobody opposed the program’s implementation that started in April last year.

Aquino arrived an hour before the 10 a.m. hearing called by the Senate Blue Ribbon as well as health and demography committees. His former executive secretary Paquito Ochoa and budget secretary Florencio Abad were also present to shed light on the alleged “hasty” vaccine procurement.

In justifying the need to protect the people from dengue, Aquino pointed out that a few months after he assumed office in 2010, then health secretary Enrique Ona presented to him an alarming report on the surge in dengue cases nationwide.

In Ona’s memo, Aquino said dengue cases increased by 100 percent in Regions 3 and 5 and 1,409.5 percent in Region 8. “What’s frightening here is, if there are an estimated 200,000 cases of dengue each year, and it is possible for them to increase 14 times like what happened in Region 8, the number of those who may potentially get infected is 2.8 million,” the former president said.

He said at the time, Ona also reported that various pharmaceutical companies were still developing and testing dengue vaccines.

Aquino said from what he understood when Dengvaxia came out in the market during the time of health secretary Janette Garin who replaced Ona in 2015, the local and international processes had already been completed before the vaccines were marketed.

He noted they checked the United States’ Food and Drug Administration and were told that Dengvaxia underwent one of its phases for approval of a vaccine.

“Let me also stress: Dengvaxia was not only approved in the Philippines. Mexico and Brazil came before us. Let me point out further: in my opinion and understanding, it has gone through all the processes to find out its efficacy and more importantly, its safety,” Aquino said.

Dengvaxia is the brand name of the vaccine manufactured by French pharmaceutical giant Sanofi Pasteur, which last November reported that it could cause a severe type of dengue for those who have not yet previously contracted the disease.

“If the report of Sanofi did not come out, and I decided to let ordinary Filipinos suffer when there is already a vaccine, I think your questions and charges against me will be different: ‘Why did you neglect your countrymen?’” Aquino said in Filipino.

“How can I explain to grieving mothers who lost their children that there was available protection for them (from dengue) but deprived them of it?” he said.

Aquino said if the government projection was that dengue cases could reach 2.8 million and patients might all need blood transfusion, hospitalization and skip school or work, the government would have to shell out P58.2 billion in health insurance payments for an estimated P20,800 hospitalization cost for each case.

“Let me emphasize: before the government decided on Dengvaxia, while deciding and after deciding, nobody relayed to me an objection to the vaccine,” Aquino said.

In a press conference after the hearing, Aquino said: “It was incumbent upon us to be able to look for systems, procedures, means to protect the people. And around that time, the vaccine, good for all four strains, was being developed and nearing completion of all the steps before it could be made available for everybody.”

Nothing irregular

Aquino stressed there was no irregularity in the purchase of the vaccines as he clarified the alleged haste by which they were procured.

The possibility of procuring the vaccines from Sanofi was first raised during Aquino’s meeting with its executives on the sidelines of Asia-Pacific Economic Cooperation Summit in November 2014, and then in Paris in December 2015 on the sidelines of the United Nations Climate Change Conference or COP 21.

Aquino said the 2014 meeting was coursed through the Department of Health (DOH).

Then, Sanofi said the vaccine was being produced and tested at the same time in other countries.

The P3.5 billion for the vaccine was requested following the December meeting in Paris, he said.

Aquino said the funds for the purchase of the vaccine, which was not specifically mentioned in the 2015 national budget, were realigned from the Miscellaneous Personnel and Benefits Fund in the budget.

Upon questioning from Sen. Joseph Victor Ejercito, chairman of the health and demography committee, Aquino said there was a need to both rush the registration of the vaccine with the Food and Drug Administration and the national formulary and the search for fund as his term was about to end and dengue situation was critical.

“How can we fund something that was not legally existent at that time?” Aquino said, referring to Dengvaxia’s listing in the government.

Aquino said the expansion of the vaccination program was provided in the 2015 budget but was not specified yet because of the uncertainty on the rollout of vaccines.

Aquino said to wait for the 2016 budget meant the vaccination would be delayed for a year, risking the lives of children. Asking for a supplemental budget from Congress would also take a while.

Thomas Triomphe, head of Sanofi Pasteur for the Asia-Pacific region has assured the public that there is no cause for alarm over the use of Dengvaxia as the vaccine continues to be safe and effective in providing persistent protection against the dengue infection.

He told the hearing there is no “worldwide” scare over Dengvaxia, which continues to be marketed and used in 10 other countries.

“It is important for the public to understand that the vaccine continues to be good, effective and safe,” Triomphe said. “There is no reason for public panic.”

He said Sanofi Pasteur is ready to “collaborate and reengage” with the DOH in contributing to the investigations to be done by the task forces on the review of the government’s dengue immunization program.

“Your honor, I understand the question and the concerns. I want to make sure that people understand that we have been a long-term partner of the Philippines’ DOH, and we want to remain a long-term partner of the Philippines’ DOH as we are with the various departments of health all over the world,” he said.

Triomphe said Dengvaxia has clearly been shown to offer “persistent protection” against dengue fever, which is “undeniably beneficial” for a country like the Philippines where 150,000 to 200,000 cases of the disease are reported every year, one of the highest in the world.

“It is an inescapable truth that, in the Philippines, dengue is not just a risk, it is a reality. It is not isolated; it is endemic. As such, the Philippines stands to benefit most from Dengvaxia,” he said.

Permanently removing the vaccine from the Philippine market on the basis only of a reported 0.02 percent increased risk of dengue symptoms would be a big step backward in the country’s approach to solving a major public health concern and a disservice to the Filipino people, Triomphe said.

During the hearing, Aquino also appealed to authorities to calm the people rather than scare and paralyze them.

WHO advisory

Following Sanfoi’s disclosure, the World Health Organization (WHO) has issued an advisory against the use of Dengvaxia to people not previously infected with the mosquito-borne illness.

WHO also called for enhanced measures to minimize exposure of dengue illness for seronegative vaccinated people.

“For vaccine recipients who present with clinical symptoms compatible with dengue virus infection, access to medical care should be expedited to allow for proper evaluation, identification, and management of severe forms of the disease,” WHO said.

The WHO issued the advisory Wednesday following consultation of the Global Advisory Committee on Vaccine Safety.

“This new recommendation is based on new evidence communicated by vaccine’s manufacturer, Sanofi Pasteur indicating an increase in incidence of hospitalization and severe illness in vaccinated children never infected with dengue,” WHO said.

“The magnitude of risk is in the order of about (four) out of every 1,000 seronegative patients vaccinated who developed severe dengue disease during five years of observation,” WHO noted.

According to WHO, the risk of developing severe dengue disease in non-vaccinated individuals has been calculated as 1.7 per 1,000 over the same period of observation.

“By contrast, for the 85 (percent) who have had dengue disease before immunization, there is a reduction of (four) cases of severe dengue per 1,000 who are vaccinated,” the WHO added.

In July 2016, WHO already raised the possibility of risk for seronegative people or those who did not have previous infection.

“Vaccination may be ineffective or may theoretically even increase the future risk of hospitalized or severe dengue illness in those who are seronegative at the time of first vaccination regardless of age,” WHO said in its position paper.

“As this risk had at that time not been seen in the age groups for which the vaccine was licensed, WHO issued a conditional recommendation, emphasizing the use of the vaccine in populations having been previously infected with dengue virus,” WHO stressed.

Pressured

Meanwhile, former health secretary Paulyn Ubial yesterday claimed she was pressured by lawmakers, including the husband of her predecessor, to continue implementing the controversial dengue vaccination program of the previous administration.

Ubial told the hearing that Reps. Gwendolyn Garcia of Cebu and Oscar Garin of Iloilo City were among the lawmakers who also “badgered” her to increase funding for the program during deliberations on the DOH budget last year.

Garin is the husband of Janette Garin, former health secretary, who is being accused of favoring Sanofi Pasteur.

Ubial said she was certain her opposition to the continued use of Dengvaxia led to the rejection of her appointment by the Commission on Appointments. – With Mayen Jaymalin, Ding Cervantes