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DOJ indicts Garin, 19 others over alleged Dengvaxia-linked deaths

The Department of Justice (DOJ) has found probable cause to indict former Health secretary Janette Garin and several others for reckless imprudence resulting in homicide in connection with the deaths of eight children allegedly due to the Dengvaxia vaccine.

In a statement on Friday, the DOJ said state prosecutors found Garin and the other respondents "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."

"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.

The prosecutors also found cause to charge nine other officials from the Department of Health, two from the Food and Drug Administration, two from the Research Institute for Tropical Medicine, and six from vaccine maker Sanofi Pasteur for the same offense.

The crime is punishable by a prison term of up to six years. According to Justice Undersecretary Markk Perete, the cases will be filed before the regional trial courts in the places where the alleged offenses were committed.

Complaints against incumbent Health Secretary Francisco Duque III, former department officer-in-charge Herminigildo Valle, and officers of Zuellig Pharma Corporation were dismissed.

The resolution covers 9 of 35 complaints mostly filed by parents of Dengvaxia recipients who died of different causes. Of the nine, one was dismissed for "insufficiency of evidence." Prosecutors have yet to resolve the remaining 26 complaints, which made similar allegations against the same set of respondents.

Represented by the Public Attorney's Office, the complainants based their allegations on findings by the PAO forensic team that linked the causes of death to vaccination with Dengvaxia.

The DOH has repeatedly asserted that the supposed connection has not been proven, and experts have faulted the PAO for its "vague," "non-specific" and supposedly inconclusive findings.

Sought for comment, Garin said she respects the resolution but believes the case is "very weak because there is absolutely no evidence linking the vaccine to the deaths."

"I am more concerned with the impact of the decision on the already suffering DOH immunization program," she said in a text message to reporters.

"People might think again that there is something wrong with the vaccine which is not true. Let us put primary importance to saving lives rather than politicking."

'Risks materialized with deaths'

However, the DOJ said the panel of investigating prosecutors concluded that the respondents showed reckless imprudence when they "totally disregarded the identified risks and adverse effects of the vaccine."

"Said risks materialized with the death of the victims," the department said without explaining.

These "risks" included allergic or anaphylactic reaction, viscerotropism and neurotropism and an increase in severity of dengue disease from the start of vaccination, the PAO alleged in its complaints.

Additionally, the DOJ said the prosecutors found that the government bought Dengvaxia in 2016, when the vaccine was not listed in the Philippine National Drug Formulary (PNDF). The purchase of drugs not listed in the PNDF requires approval by the Formulary Executive Committee (FEC) on the basis of their safety and efficacy. 

Despite the supposed FEC finding of a "low" vaccine safety for dengue virus serotype 2, a "common type" in the Philippines, the committee recommended Dengvaxia to be conditionally exempted from the PNDF requirement, the DOJ said.

The panel of prosecutors also found that the FDA approved the vaccine's registration "despite ongoing clinical trials," the department said.

It added that since Dengvaxia was registered as a prescription drug, the vaccine should have been administered by licensed physicians and nurses and with informed consent from the recipients, but the panel found from the complaints that barangay health workers "who were not authorized to administer the vaccines actually inoculated the children." 

The parents also allegedly claimed their children were not physically examined nor asked relevant information about their health.

Sanofi, meanwhile, was faulted for "failing to actively monitor and conduct close surveillance of Dengvaxia recipients" and for not "extend[ing] any medical assistance to the victims or their families even after reports of serious adverse reactions surfaced."

Finally, the DOJ said the resolution against the officials who implemented the immunization program "should not, in any way, be used to stoke public fear of vaccination."

"The resolution in fact reiterates the high degree of accountability and caution demanded of those who adopt and implement policies and programs involving public health," it added.

Here is a list of the personalities the DOJ will charge in court for reckless imprudence resulting in homicide:

Dr. Janette Garin
Dr. Vicente Belizario, Jr.
Dr. Kenneth Hartigan-Go
Dr. Gerardo Bayugo
Dr. Lyndon Lee Suy
Dr. Irma Asuncion
Dr. Julius Lecciones
Dr. Maria Joyce Ducusin
Dr. Rosalind Vianzon
Dr. Mario Baquilod
Maria Lourdes Santiago
Melody Zamudio
Dr. Socorro Lupisan
Dr. Maria Rosario Capeding
Carlito Realuyo
Stanislas Camart
Jean Louis Grunwald
Jean Francois Vacherand
Conchita Santos
Jazel Ann Calvo