MANILA (2nd UPDATE) - State prosecutors formally accused former Health Secretary and now Iloilo Rep. Janette Garin and several others of reckless imprudence resulting in homicide over the deaths of 8 children who received the dengue vaccine Dengvaxia.
Also charged were 9 other officials of the Department of Health, Food and Drug Administration, Research Institute for Tropical Medicine, and drug maker Sanofi Pasteur.
Prosecutors found that there was "inexcusable lack of precaution" on the part of Garin and other health officials in the procurement process for the Dengvaxia vaccine, Justice Asst. Secretary Neal Bainto said on Friday.
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 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," Batin said.
If convicted, Garin and the other respondents face up to 6 years in prison for each of the accusations.
While she said she has yet to receive a copy of the resolution, Garin claimed that the issue was only "politicized" in the Philippines.
"Haharapin ko ito ng buong tapang at walang takot dahil alam natin ang katotohanan," she said in a statement Friday.
(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," she added.
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.
Sanofi, which has maintained no death was confirmed to have been caused by Dengvaxia, said it disagrees with the decision of the justice department but welcomes the opportunity to "present evidence to support our claim that Dengvaxia is safe and effective."
"We stand by the safety of Dengvaxia as the first and only licensed dengue vaccine in the world," the drugmaker said, adding that the World Health Organization includes Dengvaxia in its list of essential medicines, and is licensed for use in close to 20 countries, including the USA and European Union countries.
"As a global company that has been in the Philippines for over 50 years, we affirm our unyielding commitment to providing innovative healthcare solutions for all Filipinos. We will continue supporting the Philippine government to ensure that we all work together in the fight against vaccine-preventable diseases," it said.