DOJ eyes more raps vs Garin, others over Dengvaxia

MANILA, Philippines — The Department of Justice intends to file this week before courts in the National Capital Region (NCR) and Central Luzon cases of reckless imprudence resulting in homicide against former health secretary and incumbent Iloilo Rep. Janette Garin and other officials for the eight children who died after inoculation with the anti-dengue Dengvaxia vaccine, a DOJ official said yesterday.

In a statement released last Friday, the DOJ did not identify the respondents in the resolution of the preliminary investigation for the second batch of Dengvaxia complaints case, except for Garin.

 The DOJ merely stated that there were nine other officials from the Department of Health (DOH) and other officials from the Food and Drug Administration (FDA), Research Institute for Tropical Medicine (RITM) and Sanofi Pasteur Inc.

Last Friday, the DOJ-National Prosecution Service (NPS) finished its resolution for the second batch of Dengvaxia complaints, and Senior Deputy State Prosecutor Richard Anthony Fadullon said “hopefully,” they would be able to file the charges within the week.

Fadullon explained that they are still preparing all the documents that will be submitted to the courts.

“The information are ready but the attachments are the ones being photocopied. The documents are a bit voluminous. It will be filed as soon as the attachments are ready,” he said.

Fadullon added that the charges would be filed in courts located in the NCR and Region 3, depending on where the victims were injected with the Dengvaxia vaccine.

“Similar to the resolution on the first batch of Dengvaxia vaccine cases, the panel (of prosecutors) found that there was ‘inexcusable lack of precaution’ on the part of Garin and other respondent officials in the ‘fast-tracking of the procurement process’ for the Dengvaxia vaccine despite being aware of its lowly efficacy results and potential risks associated with its use,” the DOJ had earlier said.

Garin and some of the respondents reportedly violated Executive Order 49, which requires the Philippine National Drug Formulary listing because the panel discovered that even before the PNDF exemption for the vaccine was granted on Feb. 3, 2016, the budget for the vaccine was reportedly already processed as early as December 2015, while the purchase request for the vaccine was made in January 2016.

The DOJ added that based on the Formulary Executive Committee deliberations, the Dengvaxia vaccines were purchased even if there were other vaccines more beneficial that could have been purchased for the National Immunization Program (NIP).

There was also opposition to the dengue vaccination program due to the low efficacy of Dengvaxia for dengue virus serotype 2, which is the common type of dengue in the Philippines.

Clinical trials for the same were set to end in November 2017.

The panel said there was also a possible Adverse Event Following Immunization that could jeopardize the NIP.

It found out that the clinical trials for the Dengvaxia vaccine were not yet completed when it was purchased and rolled out for use in the mass immunization program.

Despite ongoing clinical trials, the FDA approved the vaccine’s registration.

It also discovered that the Dengvaxia vaccine allegedly did not undergo the World Health Organization (WHO) prequalification at the time the FDA issued the Certificate of Product Registration.

Sanofi reportedly submitted its application for the registration of Dengvaxia in January 2015 and its CPR was granted in December of the same year, before the completion of the two clinical trials and before it was certified by the WHO.

The panel also said Garin and the others were reportedly careless in implementing the mass immunization program.

The respondents reportedly failed to fully inform the Dengvaxia recipients and their parents/families of the nature and risks of getting the vaccine. Thus, they failed to obtain the informed consent of recipients.

The Dengvaxia recipients were reportedly not subjected to physical examination or any pertinent health assessment prior to the inoculation of the vaccine, nor did the respondents implement any post-inoculation monitoring of recipients for any possible adverse reaction.

“Sanofi indirectly admitted that Dengvaxia is a defective product due to the risk it poses to seronegatives, or to those who have not previously contracted the dengue disease,” the panel said.

It added that Sanofi respondents, along with its president, were allegedly liable for violating the Consumer Act of the Philippines, considering that the vaccine was a prescription drug, but it was not dispensed under the supervision of a licensed practitioner and was given out even without prescription.

“The circumstance made the Dengvaxia vaccine a mislabeled drug,” the panel said.

There is nothing political about the indictment of Garin over the deaths tied to Dengvaxia, Malacañang said yesterday. – With Alexis Romero