Garin, 9 DOH execs indicted over Dengvaxia vaccine

Department of Justice (DOJ) prosecutors have found probable cause to indict former Health Secretary and incumbent Iloilo Rep. Janette Garin for reckless imprudence resulting in homicide due to the deaths of eight children injected with the antidengue vaccine Dengaxia.

Also charged were nine other officials of the Department of Health, as well as former and current executives of the Food and Drug Administration (FDA), Research Institute for Tropical Medicine, and Sanofi Pasteur Inc., the manufacturer of the vaccine.

The DOJ has yet to release a copy of the 78-page resolution.

DOJ deputy spokesperson Assistant Secretary Neal Bainto said the panel that conducted the preliminary investigation of the second batch of Dengvaxia-related deaths issued its resolution last Wednesday.

Bainto said that like the resolution on the first batch of Dengvaxia cases, the panel found that there was “inexcusable lack of precaution” on the part of Garin and other respondent government officials in the “fast-tracking of the procurement process” for the vaccine despite being aware of its low efficacy results and potential risks associated with its use.

In the latest batch of cases, the panel also found sufficient evidence to indict the president of Sanofi for violating Republic Act No. 7394 or the Consumer Act of the Philippines for manufacturing the vaccine, which posed certain risks to seronegatives, or those who have not contracted the dengue disease.

Mislabeled

The Public Attorney’s Office, which represented the parents, said the children fell sick and exhibited dengue-like symptoms before they died.

The panel found that the circumstances surrounding the dispensation of Dengvaxia made the vaccine a mislabeled drug and held liable the president of Sanofi and four of its other officers or directors for violating the same act.

The panel also found that respondent government officials were reckless when they allowed the purchase of Dengvaxia vaccine despite red flags already known to them.

It also found out that 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.

According to the prosecutors, Garin and the other respondents were careless in implementing the mass immunization program as they failed to fully inform the Dengvaxia recipients of the nature and risks of the vaccine and obtain informed consent.

The panel found that Sanofi indirectly admitted that Dengvaxia was a defective product due to the risk it poses to seronegatives.