MANILA, Philippines (Update 1, 4:54 p.m.) — The Department of Justice charged Rep. Janette Garin (Iloilo, 1st District) and nine others on reckless imprudence resulting to homicide over the controversial anti-Dengue vaccine Dengvaxia.
In a press release Friday, DOJ said that state prosecutors found probable cause to indict Garin, former Health secretary, and officials of the Department of Health, Food and Drug Administration, Research Institute for Tropical Medicine and Sanofi Pasteur Inc. for reckless imprudence resulting to homicide.
“The Panel [of prosecutors] concluded that the accomplishment of the procurement process for the Dengvaxia vaccine, with undue haste, within a limited timeframe, and despite the red flags known to Garin and other respondents, amounted to reckless imprudence,” DOJ said.
Prosecutors also noted that Dengvaxia was purchased and rolled out for use even though clinical trials for the anti-Dengue vaccine were not yet completed.
“The panel found that there was no showing that the Dengvaxia vaccine had undergone [World Health Organization] prequalification at the time the FDA issued the [Certificate of Product Registration,” the release provided by Justice Assistant Secretary Neal Bainto read.
The prosecution also found that those accused did not fully inform, and obtain the consent of, those who were vaccinated and their families of the “nature and risks” of Dengvaxia.
There was also no physical examination or health assessment before the inoculation of the vaccine, the Justice department said.
A copy of the full resolution on the complaint has yet to be made available as of this story’s posting.
Violation of consumer act of the Philippines
DOJ also said that state prosecutors indicted the president of Sanofi Pasteur for violating the Consumer Act of the Philippines "for manufacturing the Dengvaxia vaccine which poses certain risks to seronegatives, or to those who have not previously contracted the Dengue disease."
“The Panel found that Sanofi indirectly admitted that Dengvaxia is a defective product due to the risk it poses to seronegatives,” it said.
This is in violation of Article 97 of Republic Act 7394 or the Consumer Act of the Philippines that holds that a product is defective if “it does not offer the safety rightfully expected of it,” including “the use and hazards reasonably expected of it.”
They also held that Sanofi respondents and the company’s president should be held liable because Dengvaxia was dispensed not under written prescription or not under the supervision of a licensed practitioner.
State prosecutors “found that the circumstances surrounding the dispensation of the Dengvaxia vaccine made the same a mislabelled drug and held liable the President of Sanofi and four of its other officers or directors for violating the same act,” the statement read.
Health Secretary Francisco Duque III suspended the dengue vaccination program after Sanofi disclosed on Nov. 27, 2017 that it could cause severe dengue if given to those who had not previously been infected with dengue.