(Eagle News) — A Department of Justice panel has found probable cause to indict former Health Secretary Janette Garin and several others over children’s deaths allegedly linked to the administration of the Dengvaxia vaccine under the then-administration’s program.
Also to be indicted for reckless imprudence resulting in homicide were nine other DOH officials along with officials of the Food and Drug Administration, the Research Institute for Tropical Medicine and Sanofi Pasteur, the dengue vaccine manufacturer.
The president of Sanofi and four of its other officers also face a case for violation of the Consumer Act of the Philippines.
In recommending the indictment of Garin and the other respondent-government officials, the panel said there was “inexcusable lack of precaution” on their part when they “fast-track(ed) the procurement process” for the vaccine despite being aware of the low efficacy results and potential risks associated with the use of such a drug.
According to the panel, the budget for the vaccine was already being processed as early as December 2015, way before it was granted a Philippine National Drug Formulary exemption from EO No. 49 s. 1993 on Feb. 3, 2016.
The EO requires the PNDF listing before drug purchases by the government can be made.
The panel also found that Garin and the respondent government officials were reckless when they allowed the purchase of the vaccine despite the red flags.
According to the panel, based on the Formulary Executive Committee deliberations:
1. the purchase of the Dengvaxia vaccine was done despite there being more beneficial vaccines that could have been purchased for the National Immunization Program
2. the dengue vaccination program was originally slated as a “demonstration project” for 2017
3. there was opposition to the dengue vaccine program due to the low vaccine efficacy for the most common type of dengue in the Philippines
4. the clinical trials were set in the end of November 2017
5. there was a possibility of an adverse event following immunization
In recommending the indictment of Sanofi officials for violation of the Consumer act, the panel said the company indirectly admitted that Dengvaxia was a defective product due to the risk it poses to seronegatives or to those who have not yet contracted the dengue disease.
“Relevantly, under article 107 of the same law, in case the manufacturer of a product is a corporation, the penalty shall be imposed upon its President, who faces a penalty of fine and imprisonment of not less than three months but not more than two years or both,” the panel said.
It added the Sanofi officials violated Article 89 in relation to articles 30 and 95, “considering that Dengvaxia was a prescription drug but was not dispensed under the supervision of a licensed practitioner and neither was it dispensed upon written prescription.”
The panel said this made Dengvaxia a “mislabeled drug.”
The panel was composed of four investigators.
The resolution covers the second batch of complaints stemming from the deaths of eight children.
