Government prosecutors who conducted the preliminary investigation into the second batch of complaints on the deaths of children inoculated with Dengvaxia vaccine found probable cause to indict former Health secretary and now Iloilo Representative Janette Garin and nine other Health department officials.
Also to be charged with reckless imprudence resulting to homicide were officials of the Food and Drug Administration (FDA), Research Institute for Tropical Medicine (RITM), and Sanofi Pasteur, Inc. (Sanofi).
The Department of Justice also found sufficient evidence to indict the president of Sanofi Pasteur, Inc. for violating the Consumer Act of the Philippines for manufacturing the Dengvaxia vaccine which poses certain risks to seronegatives, or to those who have not previously contracted the Dengue disease.
In a resolution, the DOJ stated there was “inexcusable lack of precaution” on the part of Garin and the other respondent government officials in the “fast-tracking of the procurement process” for the Dengvaxia vaccine despite being aware of its low efficacy results and potential risks associated with its use.
Executive Order No. 49,s. 1993 requires Philippine National Drug Formulary (PNDF) listing before drug purchases by the government can be made, subject to certain exceptions.
The DOJ noted that even before the PNDF exemption of the Dengvaxia vaccine was granted on 03 February 2016, the budget for the same was already being processed as early as December 2015, while the purchase request for the vaccine was made as early as January 2016.
It added that respondent-government officials were reckless when they allowed the purchase of the Dengvaxia vaccine despite red flags already known to them.
Based on the Formulary Executive Committee (FEC) deliberations made available to the Panel, it was found that: 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 (NIP); (2) the Dengue vaccination program was originally slated as a “demonstration project” for 2017 under the NIP as it was admitted that it would be more prudent to wait for the WHO pre-qualification of the vaccine; (3) There was opposition to the Dengue vaccination program due to the low vaccine efficacy of Dengvaxia for dengue virus serotype 2 - which is the common type of dengue in the Philippines; (4) the clinical trials for the same was set to end in November 2017; and (5) there was a possibility of an Adverse Event Following Immunization (AEFI) which could jeopardize the NIP.
The prosecutors also found that clinical trials for the Dengvaxia vaccine were not yet completed when it was purchased and rolled out for use in the mass immunization program.
Despite ongoing clinical trials, the FDA approved the vaccine’s registration.
Also, the DOJ ruled that Garin and the other respondents were careless in implementing the mass immunization program.
The DOJ said the respondents 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.