MANILA–Former health secretary Janette Garin on Monday formally filed her counter-affidavit before the Department of Justice (DOJ), denying her liability in the deaths of children reportedly due to the Dengvaxia dengue vaccine they received.
In a 68-page plea, Garin stressed that the multi-billion peso program had been initiated years before she was appointed as health secretary and that the program had been the product of conscientious preparation by local and international health agencies concerned.
On the other hand, Public Attorney’s Office (PAO) chief Persida Rueda-Acosta said they are “studying the possibility” of pressing for murder charges instead of the lesser charges of reckless imprudence resulting in homicide.
PAO is providing legal assistance to families of the victims.
Garin’s counsels, meanwhile, insisted there is also no probable cause to indict her for violation of the Anti-Torture Act “because said law clearly applies only to instances of punishment of person in custody,”
In her counter affidavits, Garin insisted that “all vaccines have contraindications and potential risks, which are already anticipated. But these expected events have been determined in the clinical studies as manageable and safe for humans,”
“Like in any other vaccine, the dengue vaccine has theoretical risks which were not supported by an empirical data at the time of the implementation of the dengue immunization program. It was only on Nov. 29 ,2017 that Sanofi made a disclosure that based on new data, it would be more advisable to administer the vaccine to seropositive individuals,” Garin said in her plea.
The belated disclosure, complainants claimed, resulted in the deaths because the vaccine resulted in severe illness for “seronegative” patients or those who have not had dengue before the inoculation.
“But it should immediately be clarified that in the Philippine setting, as confirmed by the WHO (World Health Organization), there is already at least 85% seroprevalence. Hence, the introduction of the vaccine is highly beneficial to the population,” Garin said, adding that clear and specific safety guidelines were issued before the implementation of the school-based immunization program.
Garin argued that as early as 2013, the Philippines represented by the Food and Drug Administration has been a member of a WHO-organized initiative, reviewing the product registration of a dengue vaccine.
She claimed that the registration of the dengue vaccine, the approval and implementation of the dengue immunization program went through a rigorous process, noting that the decision was backed up with studies that date back several years, conducted by local and international private and public institutions.
“(N)othing was done in haste and every step required for its implementation, including the processes for the vaccine registration, funding, procurement and the launch of the program itself were faithfully followed and complied with,” she argued.
Garin said Dengvaxia has been under development for the last two decades and it is also the first dengue vaccine to be licensed in the world.
The issuance of the license for Dengvaxia was based on the results of two very large clinical trials conducted in five countries in Asia and five countries in Latin America involving more than 41,000 subjects, she said.
An initial batch of criminal complaints in connection with children’s deaths attributed to the Dengvaxia may be decided by government prosecutors within the month.
Assistant State Prosecutor Maria Emilia Victorio said her panel will decide whether to pursue the case before the courts within this month after the panel concluded its preliminary investigation last October 30.
The said resolution will determine whether there exists probable cause to indict the respondents, including Garin, for the charges of reckless imprudence resulting in homicide under the Revised Penal Code and violations of Anti-Torture Act and Consumer Act filed by families of nine children who died after being administered with the vaccine.
The first batch of Dengvaxia cases filed last April and May involved the deaths of Aejay Bautista, Angelica Pestilos, Lenard Baldonado, Zandro Colite, Abbie Hedia, Jansyn Bataan, Mark Axel Ebonia, Rey Justin Almagno and Alexander Jaime.
Aside from Garin, other named respondents are Dr. Vicente Belizario Jr., Dr. Kenneth Hartigan-Go, Dr. Gerardo Bayugo, Dr. Lyndon Lee Suy, Dr. Irma Asuncion, Dr. Julius Lecciones, Dr. Joyce Ducusin, Rosalind Vianzon, and Mario Baquilod, Dr. Socorro Lupisan and Dr. Maria Rosario Capeding of the Research Institute for Tropical Medicine (RITM).
The executives of Dengvaxia manufacturer Sanofi Pasteur –Carlito Realuyo, Sanislas Camart, Jean Louis Grunwald, Jean-Francois Vacherand, Conchita Santos, Jazel Anne Calvo, Pearl Grace Cabali and Marie Esther De Antoni– are also included in the complaints.
The officers of distributor Zuellig Pharma in the charge sheet, on the other hand, are Kasigod Jamias, Michael Becker, Ricardo Romulo, Imran Babar Chugtai, Raymund Azurin, Nilo Badiola, John Stokes Davison, Marc Franck, Ashley Gerard Antonio, Ana Liza Peralta, Rosa Maria Chua, Danilo Cahoy, Manuel Concio III, Roland Goco and Ma. Visitacion Barreiro.
The respondents were accused of negligence through “arbitrarily, maliciously, and deliberately failure to inform the Dengvaxia recipients and their parents/families of the dangers and risks related to Dengvaxia and to obtain their informed consent.”
Two more batches of cases involving 18 other cases are undergoing separate preliminary investigation before the DOJ. Benjamin Pulta/PNA-northboundasia.com