By Jeffrey Damicog
The Department of Justice (DOJ) has approved the indictment of former Health Secretary Janette Garin and her co-respondents over their alleged liability in the deaths of those who received shots of the anti-dengue vaccine Dengvaxia.
DOJ spokesman Undersecretary Mark Perete said in a statement Friday (March 1) that the panel of prosecutors released last February 27 its resolution on the preliminary investigation conducted over the first batch of Dengvaxia complaints and found probable cause to indict the respondents “for reckless imprudence resulting in homicide.”
Citing the 127-page resolution, Perete explained the panel found Garin and the other respondents to have exhibited ‘inexcusable lack of precaution and foresight’ when they facilitated, with undue haste, ‘the registration and purchase of Dengvaxia’ and used the vaccine in implementing a school-based dengue mass immunization program.”
“The Panel found sufficient evidence that Garin and the other respondents circumvented various regulations in the purchase of P3.5B worth of Dengvaxia vaccine which constituted proof of their reckless imprudence,” according to him.
“If convicted, Garin and the other respondents face a penalty, among others, imprisonment of up to six years,” he noted.
Records showed scores of persons, mostly children, have allegedly died after being among the almost a million individuals who participated in the mass vaccination of the still experimental vaccine that was purchased by the government back in 2016 for P3.5 billion.
“The Panel concluded that Garin and the other respondents, most of whom are medical professionals, exhibited such degree of neglect when they ‘totally disregarded the identified risks and adverse effects of the vaccine.’ Said risks materialized with the death of the victims,” the spokesman stated.
Perete also pointed out that the panel found that, when the vaccine was purchased, Dengvaxia was “not listed in the so-called Philippine National Drug Formulary (PNDF).”
“Republic Act No. 9502, otherwise known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, prohibits the government from purchasing drugs and medicines which are not included in the PNDF,” he stated.
“Meanwhile, Executive Order No. 49, s. 1993 requires PNDF listing before drug purchase by the government can be made,” he added.
If there is no PNDF, Perete said there should be approval from the Formulatory Executive Committee (FEC) which issued an exemption to Dengvaxia on February 1, 2016.
However, he said the FEC deliberations revealed that the vaccine’s safety was low with one FEC member even indicating that “the vaccine may be hazardous.”
“The Panel further found that clinical trials for Dengvaxia were not yet completed when it was purchased and rolled out for use in the mass immunization program. But despite ongoing clinical trials, the FDA (Food and Drug Administration), approved the vaccine’s registration,” he said.
Though Dengvaxia manufacturer Sanofi Pasteur only filed for the vaccine’s registration on January 2015, the FDA issued its product registration on December 2015 “well before the completion of the two clinical trials.”
“The Panel further found Garin and the other respondents careless in the implementation of the mass immunization program,” said Perete.
Being a prescription drug which has to be administered by licensed physicians and more information obtained from recipients, Dengvaxia was only administered by barangay health workers and children who received the vaccine did not undergo physical examination or asked about their health.
Dengvaxia manufacturer Sanofi Pasteur was also faulted for failing to monitor and conduct close surveillance of the vaccine’s recipients as well as failed to extend medical assistance to victims or their families even after reports of serious adverse reactions surfaced.
In the DOJ resolution, Garin and her co-respondents will be indicted for eight counts of reckless imprudence resulting to homicide.
The other respondents were Department of Health (DOH) officials Drs. Gerardo Bayugo, Lyndon Lee Suy, Irma Asuncion, Julius Lecciones, Maria Joyce Ducusin, Rosalind Vianzon, and Mario Baquilod; former DOH officials Drs. Vincent Belizario Jr. And Kenneth Hartigan-Go; RITM officials Drs. Socorro Lupisan and Maria Rosario Capeding; and Sanofi Pasteur officials Carlito Realuyo, Stanislas Camart, Jean Louis Grunwald, Jean Francois Vacherand, Conchita Santos, and Jazel Anne Calvo.
Also to be indicted for four counts are FDA officials Maria Lourdes Santiago and Melody Zamudio.
On the other hand, the panel dismissed the other complaints, including those filed against DOH Secretary Francisco Duque III.