Garin, Sanofi face fresh charges over Dengvaxia-linked deaths
Metro Manila (CNN Philippines, February 21) — The Department of Justice has found probable cause to charge former Health Secretary Janette Garin and several co-accused of reckless imprudence resulting in homicide over deaths being linked to controversial dengue vaccine Dengvaxia.
This is the second time that state prosecutors indicted now Iloilo Rep. Garin, other former government officials, and French manufacturer Sanofi Pasteur. The DOJ in a statement on Friday noted that the prosecutors' findings were similar to the first batch of complaints over the Dengvaxia-linked deaths – that Garin and other government officials showed "inexcusable lack of precaution" and carelessness in using the vaccine for the government's mass immunization program in 2016 despite potential health risks.
"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," the DOJ said. The crime is punishable with up to six years in jail for each count.
Aside from Garin and Sanofi Pasteur, nine other DOH officials, including those from the Food and Drug Administration and Research Institute for Tropical Medicine are facing the same criminal charges.
In a statement, Garin maintained her innocence, noting that of the seven criminal cases filed against her, six have been dismissed for "lack of basis and substance." She also insisted that there is no scientific evidence that the Dengvaxia drug leads to deaths.
"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," Garin said in a statement.
The Philippines implemented in 2016 the use of Dengvaxia, the world's first dengue vaccine, but prosecutors said clinical trials were not yet completed prior to the purchase and rollout. More than 830,000 children were vaccinated.
In November 2017, Sanofi disclosed that those without prior dengue infection are at risk of having "severe disease" if immunized with Dengvaxia. The DOH said around 10 percent or 80,000 of vaccinated children were at risk. The DOH has since stopped the dengue vaccination program.
TIMELINE: The Dengvaxia controversy
The prosecutors said respondents failed to fully inform the recipients and the recipients' families of the nature and potential risks from the vaccine, and that no pertinent health assessment was done prior to administering the vaccine. The recipients were also not monitored for any possible adverse reaction, the prosecutors noted.
The panel also found sufficient evidence to charge the President of Sanofi Pasteur for violating the Consumer Act of the Philippines for manufacturing a "defective product." It noted that the law defines a product as defective when "it does not offer the safety rightfully expected of it."
"The Panel found that 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 DOJ said.
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 Food and Drug Administration 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.
Duque then stressed that if Malacañang would allow the sale of Dengvaxia in the country, "it has to be under very strict conditions."
