For the second time, the Department of Justice (DOJ) has indicted former Health secretary Janette Garin and several other health officials over children's deaths allegedly linked to the dengue vaccine Dengvaxia.
Garin, nine officials of the Department of Health (DOH), and officials of the Food and Drug Administration, Research Institute for Tropical Medicine, and vaccine maker Sanofi Pasteur, Inc. were charged with reckless imprudence resulting in homicide.
Prosecutors also found "sufficient evidence" to indict the president and four officers of Sanofi Pasteur for violating the Consumer Act of the Philippines, the DOJ said Friday.
In a statement, Garin said the charges were baseless and reek of politics.
"Haharapin ko ito ng buong tapang at walang takot dahil alam natin ang katotohanan," Garin said in a statement sent to GMA News Online.
"Sa sitwasyong ito, ang tunay na hustisya ay dapat makinig sa siyensya at hindi sa pamumulitika," she added.
The indictments were the outcome of the second batch of complaints filed by the parents of eight children who died allegedly after being inoculated with Dengvaxia.
Garin, now a congresswoman of Iloilo, and several others were also charged in court over the first batch of cases.
The DOJ said the prosecutors' resolution was released on Wednesday, but a copy was not immediately made available to reporters.
In a statement, the DOJ said prosecutors found that the respondents procured the dengue vaccine "with undue haste," "within a limited timeframe," and "despite the red flags" allegedly known to them.
They also found that the government bought and rolled out Dengvaxia for its mass immunization program even before clinical trials for the vaccine were completed, the DOJ said.
Garin and her fellow health officials were also found to have been "careless" in implementing the vaccination program as they "failed to fully inform the Dengvaxia recipients, and their parents/families, of the nature and risks of the vaccine."
"Thus, they failed to obtain the informed consent of its recipients," the DOJ said.
The recipients of the vaccine also did not undergo a physical examination or health assessment prior to inoculation and were not monitored afterwards "for any possible adverse reaction," the DOJ said.
They face up to six years in prison for each count of the offense if convicted.
On the other hand, the panel of investigating prosecutors indicted Sanofi officers, including its president, for violation of Article 89, in relation to Articles 30 and 95 of the Consumer Act.
Prosecutors said Dengvaxia was a prescription drug but was not dispensed under the supervision of a licensed practitioner nor with a written prescription.
"Said circumstances made the Dengvaxia vaccine a mislabeled drug," the DOJ said.
The offense is punishable by the payment of a fine or imprisonment of three months to two years, or both.
The vaccine manufacturer's president was solely indicted for another violation of the Consumer Act over Dengvaxia allegedly being a "defective product."
"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.
The penalty upon conviction is a fine or up to a year in prison, or both.
The DOJ is still investigating several complaints filed over children's deaths that their parents, assisted by the Public Attorney's Office (PAO), claimed was caused by the dengue vaccine.
For its part, the DOH has said the supposed connection between the vaccine and the deaths has not been proven, and experts have faulted the PAO for its "vague," "non-specific" and supposedly inconclusive autopsy findings.
In November 2017, Sanofi Pasteur announced that its product may lead to “severe” dengue symptoms among patients who have not had dengue before immunization.
The government's dengue immunization program, which by then had reached more than 800,000 school children, was suspended shortly after the Sanofi disclosure.
Health Secretary Francisco Duque III has blamed PAO chief Persida Rueda-Acosta for "sowing fear" of vaccination among the public. The chief public attorney denied it.—NB, GMA News