If convicted, former Health Secretary and now Iloilo Rep. Janette Garin and few other officials of the Department of Health (DOH), Food and Drug Administration (FDA), Research Institute for Tropical Medicine, and drug maker Sanofi Pasteur will face up to 6 years in prison for each of the of 8 children who died after receiving the dengue vaccine Dengvaxia.
Clinical trials were not yet completed “prior to the purchase and rollout”
The first public dengue mass vaccination program started in 2016 and when Sanofi Pasteur had warned in November of 2017 that the vaccine could make symptoms worse to those who were not yet exposed to the dengue fever and may risk getting “severe disease” if immunized with Dengvaxia, health officials in the Philippines ordered to stop the vaccination program. In connection to this, the DOH admitted that around 10 percent or 80,000 of vaccinated children were at risk.
However, it was reported that 14 children died and people have suspected that the vaccine may have caused these deaths. Because of this, the Philippine government has conducted an investigation regarding these deaths and as a result, some health officials concluded that three of those deaths “may” be connected to the Sanofi Pasteur’s Dengvaxia vaccine.
“Inexcusable lack of precaution”
According to Justice Asst. Secretary Neal Bainto, Garin and other health officials in the might face jail terms due to lack of necessary precaution during the procurement process of the vaccination program. Prosecutors also found strong evidence against the president of Sanofi Pasteur for violating the Consumer Act of the Philippines for manufacturing a “defective product” as “it does not offer the safety rightfully expected of it.” According to the Department of Justice (DOJ), “the manufacturer Sanofi Pasteur indirectly admitted that the vaccine is defective because of its knowledge of the risk it poses to the “seronegatives”, or to those who have not previously contracted the Dengue disease.
“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,” Justice Asst. Secretary Neal Bainto said.
Commenting on the indictment, Janette Garin said, “I will face this without fear because I know the truth. Science has proven over and over again that no deaths have been linked to the Dengvaxia vaccine. Almost the whole world is using it now and no case like ours has surfaced.”
Meanwhile, Dengvaxia manufacturer Sanofi Pasteur denied this claim and took no responsibility for the death of the children. It was also reported by CNN Philippines that “in November 2019, Health Secretary Francisco Duque said Sanofi Pasteur had appealed the revocation of its certificate of product registration to the Office of the President. The FDA first suspended Dengvaxia’s registration in 2017. Two years after, the Department of Health rejected Sanofi Pasteur’s plea for it to reverse the FDA’s decision. Duque said Sanofi Pasteur failed to submit the required documents on its risk management plans”.
- State prosecutors indict ex-DOH chief Garin over Dengvaxia-linked deaths
- Garin, Sanofi face fresh charges over Dengvaxia-linked deaths
- Sanofi sued over alleged dengue vaccine death
- Dengvaxia: 153 Deaths and Permanent License Revocation
- Featured image: Dengue vaccine fiasco leads to criminal charges for researcher in the Philippines