Dengvaxia deal rushed for polls?

MANILA, Philippines — In a transaction described as a “disastrous mix of health and politics,” then President Benigno Aquino III in December 2015 authorized the realignment of P3.5 billion in that year’s budget for the purchase of the Dengvaxia vaccine, whose application is feared to have exposed at least 70,000 vaccinated children to life-threatening risks.

During the joint hearing of the Senate Blue Ribbon and health committees on the Dengvaxia controversy, Department of Budget and Management (DBM) director Cristina Clasara said the Office of the President, through then executive secretary Paquito Ochoa, authorized the DBM to realign a total of P12 billion from the Miscellaneous Personnel Benefits Fund (MPBF) provision for various health projects.

Of the P12 billion, P3.5 billion was realigned for the Department of Health (DOH)’s dengue vaccination program using Dengvaxia – a vaccine made by France’s Sanofi Pasteur – that started in April 2016 or a month before the presidential elections.

Senators during the hearing indicated that, offhand, there was nothing apparently illegal in Aquino’s move but it clearly showed his involvement in the purchase of Dengvaxia that they said was clearly done in suspicious haste, considering the magnitude of the transaction by government standards.

“We do not conduct vaccination programs during elections as this would be tainted as a hidden agenda of somebody,” said former health secretary Paulyn Jean Ubial, the Duterte administration’s first DOH chief who had resisted the program.

“Mixing politics and health will lead to disaster,” she said, adding while she formally and strongly opposed the continued implementation of the vaccination program, she relented after she was warned by lawmakers and officials that she could be sued for reneging on a fully paid contract.

She said she was glad that she “dilly-dallied” and “flip-flopped” on the program or the number of people – mostly schoolchildren – inoculated with Dengvaxia would have been much higher.

Sen. Joseph Victor Ejercito, chairman of the health committee, cited the apparent shortcuts in the release of the funding, registration and listing of Dengvaxia by various agencies under the DOH, including the Food and Drug Administration (FDA) and the Formulary Executive Council (FEC), which lists the drugs that government agencies can purchase.

Sen. Richard Gordon, chairman of the Blue Ribbon committee, said on Dec. 1, 2015, Aquino met with Sanofi officials on the sidelines of the climate change conference in Paris.

Nine days later, then health secretary Janet Garin submitted a proposal to the DBM for the procurement of three million doses of dengue vaccine. On Dec. 22, the FDA approved the marketing of Dengvaxia. The following day, then budget secretary Florencio Abad recommended to Aquino the release of P3.5 billion as sought by Garin.

On Dec. 29, the DBM issued a Special Allotment Release Order for the funds.

In January last year, Garin made representations to the DOH-run Philippine Children’s Medical Center (PCMC) to purchase Dengvaxia without the approval of the FEC. That same month, PCMC made the purchase order to Zuellig Pharma, the sole distributor of Dengvaxia in the country.

“Why the haste?” Gordon asked during the hearing, adding that the actions to release funds exerted strong pressure on various agencies like the PCMC, FDA and FEC to facilitate the process.

He said the budget for Dengvaxia was bigger than the combined allocations for seven existing vaccination programs of the government.

He said the release of such a huge amount needs a “higher influence.”

Health Secretary Francisco Duque III accused Sanofi of “mental dishonesty” when it apparently downplayed the adverse effects of Dengvaxia.

Duque also said the DOH has all the records of those inoculated with the vaccine and is now preparing a master list to monitor them.

‘Safe and efficacious’

Thomas Triomphe, Sanofi vice president and head of its Asia-Pacific division, warned against totally scrapping the vaccination program, saying it could lead to loss of lives.

“We have not seen any fault or negligence on the part of the company,” Triomphe told the hearing. “We at Sanofi assure each and every one of you that Dengvaxia is, and continues to be, a safe and efficacious vaccine.”

He 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 that Sanofi continues to monitor all vaccinations not only in the Philippines but also in other countries where Dengvaxia is used.

He said the risks associated with Dengvaxia may affect only 0.02 percent of those injected with it.

“To permanently remove the vaccine from the Philippine market, on the basis only of the reported 0.02 percent increased risk of getting traditionally known symptoms, would be regression in the country’s approach to solving a major public health concern and a disservice to the Filipino people,” he said.

Gov’t must examine vaccine

It is within the mandate of the National Unified Health Research Agenda (NUHRA) to examine Dengvaxia.

NUHRA must look into and address issues like this in line with global and national initiatives influencing the health sector, said Science and Technology Secretary Fortunato dela Peña.

The DOST could research on Dengvaxia since the department is part of the core group that makes up NUHRA, together with the DOH, Philippine Council for Health Research and Development of the Department of Science and Technology, Commission on Higher Education and University of the Philippines Manila-National Institute of Health.

Dela Peña said the research agenda could guide the scientific community on studies that should be undertaken to address the health needs of Filipinos.

He made the statement right after delivering his message during yesterday’s Central Luzon Technology Transfer Day at Widus Hotel at Clark Freeport Zone in Pampanga.

Group demands refund

Child rights advocates demanded yesterday the full refund for the Dengvaxia vaccine the previous administration bought from Sanofi.

The group Salinlahi also urged the government to pay for the hospitalization of the children who were vaccinated or hospitalized due to severe dengue from the vaccine. – Ramon Efren Lazaro, Helen Flores, Sheila Crisostomo