DOH eyes refund for dengue vaccine

Probes to include Aquino

MANILA, Philippines — The Department of Health (DOH) is looking into the possibility of requiring the manufacturer of the world’s first dengue vaccine to refund the government following reports that the treatment poses risks to people without a history of dengue.

“It is an option we are considering, but we also have to look into the legal issues,” Health Undersecretary Gerardo Bayugo told reporters yesterday.

The controversy on the P3.5-billion dengue immunization program broke after pharmaceutical giant Sanofi Pasteur disclosed that new clinical analysis found its Dengvaxia vaccine effective for people who have had dengue prior to immunization, but noted the risk of a “severe” case of dengue for people who have not.

Bayugo clarified that there had been no apparent irregularity in the purchase of Dengvaxia until Sanofi admitted that the vaccine only provides protection for those previously afflicted with dengue.

He explained that the DOH’s decision to implement a dengue immunization program was based on the previous findings that Dengvaxia was safe for use, and there was no complaint before the Commission on Audit concerning its purchase.

“I still believe that the DOH complied with the requirements of the law in the procurement of the dengue vaccine,” he added.

Dengvaxia was duly registered with the Food and Drug Administration (FDA) when the DOH purchased it.

The DOH also complied with the guidelines of the World Health Organization (WHO) that only areas with high dengue prevalence shall be covered by the program.

Bayugo said the new findings were not yet available when the immunization program was started.

“Based on studies, the children died of other causes and it just so happens that they were vaccinated,” he added.

Bayugo also gave assurances that the DOH will face any investigation on Dengvaxia.

Aquino liable for vaccine mess?

The Department of Justice (DOJ) yesterday said it will investigate all officials involved in the dengue vaccine mess, including the possible liability of former president Benigno Aquino III and health secretary Janette Garin.

Justice Secretary Vitaliano Aguirre II yesterday formally ordered the National Bureau of Investigation (NBI) to conduct a probe to determine possible criminal liabilities of officials behind the project.

“The National Bureau of Investigation, through director general Dante Gierran, is hereby directed and granted authority to conduct investigation and case buildup over the the alleged danger to public health arising from the P3.5-billion anti-dengue vaccination drive of the Department of Health and Sanofi Pasteur and if evidence so warrants to file appropriate charges,” he said in his department order issued yesterday.

Aguirre also directed Gierran to submit a report to his office on its current activities related to the implementation of the order.

The DOJ chief explained that Aquino would be covered by the probe since he also approved the vaccination project that started in April last year.

Garin, who insisted on implementing the project despite strong objections from medical experts, is also covered by the NBI probe.

Aguirre cited information that the DOH under the previous administration administered the Dengvaxia vaccine just four months after it was manufactured by pharmaceutical firm Sanofi Pasteur.

Initial information reaching the DOJ also showed that the program was approved by Aquino and Garin despite lack of certification from the WHO.

“We have to know why (the DOH) ordered such a huge amount of vaccine and immediately vaccinated 733,000 schoolchildren. Is that appropriate?” Aguirre said in a press conference.

“Everybody who was involved will be included in the NBI investigation,” he added.

In the same press briefing, Volunteers Against Crime and Corruption (VACC) lawyer Ferdinand Topacio showed a photograph showing Aquino during alleged meetings with Sanofi officers in November 2014 in Beijing and December 2015 in Paris.

The VACC also claimed that there had been three children from Central Luzon who died last year after they were inoculated with the vaccine.

VACC founding chairman Dante Jimenez, who also formally requested the DOJ investigation on the controversy, said their initial information showed that all three were from Bataan.

“We are now here to request the Secretary [of Justice] to ask the NBI to conduct an exhumation [because] this is really serious,” he explained.

Senate to start probe next week

Meanwhile, the Senate will start next week its inquiry into the P3.5-billion dengue vaccine mess.

Sen. Richard Gordon, chairman of the Senate Blue Ribbon committee, set the hearing on Monday that may be held jointly with the committee on health, chaired by Sen. Joseph Victor Ejercito.

“Everybody from PNoy (Aquino’s nickname) down has to explain,” Gordon told reporters. “Also, the money should be returned.”

Gordon also said the controversy was “begging for a class suit” as the over 700,000 children vaccinated face risk of severe disease after their inoculation with Dengvaxia.

“They’ll (Sanofi) be liable to civil action for damages because of the negligence. They’re (vaccinated) now subjected to sleepless nights, anxiety,” he said.

Ejercito said he hopes officials from the DOH and the WHO will have something to report in the initial hearing.

Senate President Pro Tempore Ralph Recto said in the wake of dengue vaccine flop, DOH officials should guarantee that Filipinos are now “inoculated” from supply-driven vaccines whose efficacy has not yet been established.

“If there’s one lesson to be learned from the ‘Denggoyvaxx,’ it is that Filipino children should not be made guinea pigs again,” Recto said.

Recto made the call as the government is set to buy P7.4 billion worth of vaccines next year.

He said the DOH must still go out of its way in assuring the public that next year’s vaccines meet the highest standards

Costing P7.43 billion, the 2018 public vaccination program targets full immunization of 2.7 million infants, of which 1.4 million will be given pneumococcal vaccine.

All 2.7 million infants will also be administered Japanese encephalitis vaccine.

In addition, 2.1 million Grade 1 and 1.7 million Grade 7 pupils will benefit from anti-tetanus-diptheria, and measles vaccines. - Edu Punay, Paolo Romero