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Former DOH Secretary Janette Garin | Daily Tribune |
The Department of Justice (DOJ) on Friday formally charged former Department of Health Secretary now Iloilo Representative Janette Garin and nine others of reckless imprudence resulting to homicide over the deaths of 8-children who got inoculated with the controversial anti-Dengue vaccine Dengvaxia.
In a statement, DOJ Assistant Secretary Neal Bainto announced this, citing the 78-page resolution issued last Feb. 19 by a panel of prosecutors finding probable cause to charge Garin and her co-respondents health officials, the Food and Drug Administration (FDA), Research Institute for Tropical Medicine (RITM), and Sanofi Pasteur, Inc.
“Similar to the Resolution on the first batch of Dengvaxia vaccine cases, the panel found that there was ‘inexcusable lack of precaution’ on the part of Garin and the other respondent government officials in the ‘fast-tracking of the procurement process’ for the Dengvaxia vaccine despite being aware of its low efficacy results and potential risks associated with its use,” Bainto said.
“The panel 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 the other respondents, amounted to reckless imprudence,” he added.
“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 statement 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.
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Photo credit from Bombo Radyo Pilipinas |
The FDA approved the vaccine's registration even though clinical trials for Dengvaxia were not yet completed when it was rolled out for use in the mass immunization program.
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.
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Source: Manila Bulletin
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