Furor over anti-dengue vaccination ignites scare over other inoculation programs; further autopsy tests needed to build case vs. maker

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By Lara Climaco | FilAm Star Correspondent

The public health scare over Dengvaxia has spilled over to other vaccination and de-worming programs of the Department of Health (DoH), which now has to face long-term monitoring of about 870,000 Filipinos without an indemnity fund from Sanofi Pasteur.

“This is really a cause for concern just because of this one controversial vaccine, it has indeed tainted the credibility of the entire DoH immunization program,” Health Sec. Francisco Duque III told the House committees on good government and accountability and health at a joint hearing February 5.

He mentioned field reports indicating much lower rates of immunization coverage this year. Earlier, Health Undersecretary Rolando Domingo estimated the uptake at 60 percent. Parents in Davao are refusing measles immunization for their kids, while others in Zamboanga are resisting de-worming activities they had readily joined in the past, the DoH officials revealed.

“The immunization program is extremely crucial to prevent possible fatal illnesses to occur in the near or the far future,” Duque said.

The health secretary received another let-down during the hearing when Thomas Triomphe, Sanofi’s head for Asia-Pacific, disclosed that the company would not reimburse an additional PHP 1.8 billion for the vaccines used in the government’s mass immunization program nor set up an indemnity fund to cover medical expenses of those vaccinated with Dengvaxia.

“We cannot respond positively to these two requests. However, it does not mean that we are closing the door to any collaboration with the DoH. That’s why in our letter, we have provided other possibilities of collaboration,” Triomphe said at the House hearing.

Sanofi is willing to provide Dengvaxia doses free of charge so that inoculation may be completed among those who received just one or two shots, he added. The company is also open to “constructive action to fight dengue.”

The Dengvaxia manufacturer reimbursed PHP 1.16 billion last month for the more than one million unused Dengvaxia doses returned by the DoH, which suspended its mass dengue immunization program in December after Sanofi’s disclosure of a severe dengue risk among those to be vaccinated without a prior infection.

“In the current context, we strongly stand behind the record of efficacy and safety of this product, which is probably the reason why this product is being used in every single other country where it’s licensed today. And that’s why we don’t believe it’s the time to set up any indemnification fund, which again will probably create undue concern and undue mistrust in the over-all vaccine program,” Triomphe told committee members who grilled him repeatedly about Sanofi’s move.

This means a legal victory is needed to compel any reimbursement from Sanofi of rising government costs to monitor about 870,000 Filipinos vaccinated with Dengvaxia. Domingo revealed at the hearing that the total affected population has risen from the 833,000 involved in the mass immunization program, because about 30,000 private school students were also inoculated by private physicians.

Their surveillance is required for at least three to five years and could last for 20 years, with those vaccinated with Dengvaxia accorded a special lane at public hospitals and soon, at designated private hospitals to guarantee treatment with no out-of-pocket expenses.

The DoH is paying for all these through the Philippine Health Insurance Corp. (Philhealth) and a Medical Assistance Program for indigents.

Duque said he would discuss available options with the DoH’s dengue task force, including the possibility of hauling Sanofi to court. The dengue investigative task force (DITF) led by the Philippine General Hospital (PGH) is being thorough in its evaluation precisely to build up a case that would stand in court, he said. For instance, the DITF is using the World Health Organization’s algorithm for causality assessment to ensure that its results are universally acceptable.

Twenty-nine deaths have so far been monitored among those vaccinated with Dengvaxia, of which 14 have been reviewed by the DITF. The panel, a multidisciplinary team composed of 10 doctors at PGH, disclosed its preliminary findings at a press conference last February 2. Though noting a “causal association” in three of the cases, and probable vaccine failure involving at least two, the DITF cannot yet conclude that Dengvaxia caused the dengue shock syndrome (DSS) that killed these children. Further testing of tissue samples and antibodies is needed to complete the investigation, according to Dr. Juliet Sio-Aguilar, chairman of PGH’s pediatrics department, who leads the DITF.

Its recommendation is to perform an autopsy in nine of the cases, including six found as either “indeterminate” or “coincidental” deaths, meaning those who got ill within 30 days from inoculation but did not die from DSS.

“The autopsy is not simply opening the body and looking at the different organs, which is what you usually see on TV. It actually is a more complicated process. In a medical autopsy, we take tissues from the different organs, we process them and put them on a microscopic slide and we look at these tissues. These findings are then correlated or connected with all the clinical data that we have,” Dr. Maria Cecilia Lim, PGH forensic pathologist, said at the DoH press conference last February 2.

She said the PGH will offer free autopsy for Dengvaxia-related cases. Those living outside Metro Manila may also rely on the Philippine Society of Pathologists (PSP), which will organize a network of its members to help with Dengvaxia cases. The PSP is likewise offering its services for free, Lim said.

DITF is hoping to collaborate with the Public Attorney’s Office (PAO) in conducting the autopsies. Ordered by the Department of Justice to help bereaved parents, PAO has exhumed bodies of children whose deaths are suspected to have been caused by Dengvaxia. The agency filed a civil suit February 5 at the Quezon City Regional Trial Court, seeking more than PHP 4 million in damages on behalf of the family of a 10-year-old girl. It is the first of several individual cases the agency will pursue, PAO Chief Persida Acosta was quoted in local media reports.

Acosta and PAO forensic expert Dr. Erwin Erfe have been summoned by both the Senate and House panels investigating the Dengvaxia fiasco. Prominent members of the Philippine medical community, including former health secretaries, have criticized PAO for allegedly inflaming the public health scare by publicizing “unsubstantiated” autopsy findings.

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