Despite knowing the risks posed by the anti-dengue Dengvaxia vaccine, former Health Secretary Janette Garin still proceeded with the immunization program in 2016 that may have led to the deaths and serious illnesses of schoolchildren, the Public Attorney’s Office said Thursday.
PAO chief Persida Rueda-Acosta made this allegation during the continuation of the preliminary investigation by the Justice department on criminal complaints filed against Garin and 35 others for the deaths of at least nine children inoculated with the vaccine.
Acosta, who serves as counsels for parents of the victims, cited a letter to Garin dated March 27, 2016 from health and medical experts from various organizations that strongly warned against the implementation of the program.
The letter, signed by representatives from National Academy of Science and Technology, Philippine Medical Association, University of the Philippine College of Medicine, Philippine College of Physicians, University of Sto. Tomas, Action for Economic Forum and Woman Health, raised questions on the efficacy of the vaccine that was still on the clinical trial stage.
The experts informed Garin of “possible harm from the vaccine” that they believed was not cost-effective.
“The possibility of harm is real because the vaccine does not have a consistent effect on all serotypes of the dengue virus. Because of this, there is a possibility of immunologic enhancement, resulting in more severe diseases from a different virus serotype,” they warned Garin.
The group also pointed out that the P3.5-billion program was costly considering the lack of guaranteed efficacy and that a new generation dengue vaccine, TV003, that could have better efficacy at a lower cost was also available at that time.
“The cost-effectiveness study used by DoH was commissioned by the drug company producing the vaccine and has not been published... We believe an independent analysis needs to be performed,” they said.
However, despite these warnings from the experts, Garin still decided to pursue the vaccination program in April 2016 with manufacturer Sanofi Pasteur Inc. and its local distributor Zuellig Pharma Corp.
Acosta also presented to the investigating prosecutors records in which Sanofi admitted to these risks posed by their vaccine.
She specifically submitted documents from the National Formulary in December 2015 where the pharmaceutical firm admitted that the vaccine could lead to more severe diseases.
Sanofi said Dengvaxia could lead to allergic or anaphylactic reaction, viscerotropism and neurotropism, increase in severity of dengue diseases from start of vaccination and waning protection against dengue disease.
The PAO chief said that despite this admission by Sanofi, Garin proceeded with the vaccination program and inoculated more than 800,000 with Dengvaxia.
During the hearing, the lawyers of Garin and other respondents received copies of the complaints filed by parents of Aejay Bautista, Angelica Pestilos, Lenard Baldonado, Zandro Colite, Abbie Hedia, Jansyn Bataan, Mark Axel Ebonia, Rey Justin Almagno and Alexander Jaime.
They were given until the next hearing set for June 25 to answer the charges for reckless imprudence resulting in homicide under Article 365 of the Revised Penal Code.
Apart from Garin and other former health officials, the complaints also named as respondents executives of Sanofi and Zuellig.
A separate panel of prosecutors is investigating the complaint filed by anti-corruption groups Volunteers Against Crime and Corruption and Vanguard of the Philippine Constitution Inc. against former President Benigno Aquino III over the Dengvaxia vaccine controversy.
Aquino and 43 other respondents had earlier been ordered to appear in the next hearing set for June 4 to answer the charges of multiple homicide and physical injuries under the Revised Penal Code, malversation of public funds, and violations of Republic Act 3019 or the Anti-Graft and Corrupt Practices Act and R.A. 9184, otherwise known as Government Procurement Reform Act.
The Justice department has ordered Health Secretary Francisco Duque III, Garin and 38 others to attend the preliminary investigation on June 25.
During the hearing on Thursday, Assistant State Prosecutor Maria Emilia Victorio, who chairs the DoJ panel, issued subpoenas to 38 respondents, among them Duque and Garin, to attend the probe, submit their respective counter-affidavits, and reaffirm their sworn statements before the panel.
The panel is conducting the preliminary investigation over the criminal complaints filed separately by the families, with the help of the PAO, over the death of nine children, namely, Aejay Bautista, Anjielica Pestillos, Lenard Baldonado, Zandro Colite, Abbie Hedia, Jansyn Art Bataa, Mark Axel Ebonia, Reijazztine Justin Alimagno, and Alexander Jaime.
The PAO has been conducting autopsies of children whose death has been linked to the effects of the vaccine.