Ex-health Sec Garin, others can be charged over Dengvaxia deaths: DOJ

MANILA (UPDATE) - The Department of Justice (DOJ) said on Friday it found probable cause to indict former health chief Janette Garin and several others for reckless imprudence resulting in homicide over the deaths of 8 children who received the anti-dengue vaccine Dengvaxia.

The agency said there were enough grounds to indict Garin, 9 health officials, 2 officials of the Food and Drug Administration, 2 officials of the Research Institute for Tropical Medicine, and 6 from Dengvaxia manufacturer Sanofi Pasteur.

State prosecutors, however, dismissed the same complaint against incumbent health chief Francisco Duque III, former DOH officer-in-charge Herminigildo Valle, 2 Sanofi Pasteur officials, and 15 Zuellig Pharma officers.

Garin and the other respondents were found to have "exhibited 'inexcusable lack of precaution and foresight' when they facilitated, with undue haste, 'the registration and purchase of Dengvaxia' and used the vaccine in implementing a school-based dengue mass immunization program," according to the statement.

"The Panel found sufficient evidence that Garin and the other respondents circumvented various regulations in the purchase of P3.5 billion worth of Dengvaxia vaccine which constituted proof of their reckless imprudence," the statement said.

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As a prescription drug, Dengvaxia should only have been administered by licensed physicians and nurses, not by barangay health workers, the DOJ panel said.

The panel added that no physical examination was conducted nor questions about important health information were asked before the vaccine was administered to schoolchildren.

Among the irregularities cited by the prosecutors, the Dengvaxia vaccine was not listed in the Philippine National Drug Formulary (PNDF) and its purchase violated Republic Act No. 9502 or the Universally Accessible Cheaper and Quality Medicines Act of 2008 and Executive Order No.49.

The panel noted that the deliberations of the Formulary Executive Committee (FEC), the body tasked to approve the purchase of non-PNDF listed drugs, showed the vaccine safety of Dengvaxia for dengue virus serotype 2, the common type of dengue in the Philippines, was low.

It cited the observation of one FEC member that the vaccine “may be hazardous” but the FEC still recommended provisional exemption of Dengvaxia from the PNDF requirement for one year, subject to a “post-licensure study to determine its long-term safety and effectiveness.”

Garin earlier said in her counter-affidavit that the available data and information on Dengvaxia at the time the vaccines were purchased “all pointed to its safety and efficacy.”

She also pinned the blame on her successor, former Health Secretary Paulyn Ubial, for expanding the program to 4 regions for more than a year. Ubial was not among the respondents against whom complaints were filed.

If convicted, Garin and the other respondents face up to 6 years in prison for each of the accusations.

Responding to the DOJ's findings, Garin said in a statement: "I believe the criminal case is very weak because there is absolutely no evidence linking the vaccine to the deaths. We are confident in the dismissal of this case," she said.

"It is only the Philippines that has politicized the issue," she said.

The government stopped its nationwide dengue vaccination program and pulled Dengvaxia off the market in late 2017 after Sanofi warned that the vaccine might cause severe symptoms if given to those who did not have prior exposure to the mosquito-borne disease.

Sanofi maintained no death was confirmed to have been caused by Dengvaxia.