THE Department of Health (DoH) on Monday said it had sought the assistance of experts from the World Health Organization (WHO) to provide better response in cases of “adverse events following immunization.”
The panel is composed of pediatrician Siripen Kalayanarooj of Thailand, infectious diseases specialist Leo Yee Sin of Singapore, dengue specialist Scott Halstead of United States and pathologist Kum Thong Wong of Malaysia.
They will be joined by resource persons from WHO, Madhava Ram Balakrishnan and Ananda Amarasinghe.
The specialists will train members of the Philippine General Hospital-Dengue Investigative Task Force (PGH-DITF), National Adverse Events Following Immunization Committee (NAEFIC), the DoH-Epidemiology Bureau (EB) and DoH-National Immunization Program (NIP).
The PGH-DITF serves as an independent body analyzing the Dengvaxia-related mortalities for causality association. The NAEFIC, DOH-EB and the NIP are tasked to review non-fatal serious adverse events following immunization.
The teams began a one-week workshop with the specialists on Monday, March 12.
The DoH suspended the mass anti-dengue immunization program last year following a health advisory from drug manufacturer Sanofi Pasteur that is anti-dengue vaccine Dengvaxia might cause severe dengue in first-time dengue patients.
In a report by the independent expert panel from the University of the Philippines and Philippine General Hospital, three deaths out of 14 children who were inoculated with Dengvaxia were found to have “causal association” with the vaccine.
The dengue immunization program was initiated in 2016 as a school-based program under the health secretary Janette Garin. An estimated 830,000 individuals were inoculated with the vaccine.
Without admitting to any wrongdoing, Sanofi last month reimbursed the DoH the amount of P1.16-billion for unused doses of Dengvaxia. It refused to return the full P3 billion paid by the government for the Dengvaxia deal.
The DoH has ordered the filing of a civil case for damages against the French pharma giant.
‘Ban DoH staff in clinical studies’
In the wake of the Dengvaxia mess, pharmaceutical firms should be banned from using DoH staff and facilities to conduct clinical studies on new vaccines or medicines, especially those pending regulatory approval, a senior member of Congress said.
“This practice of allowing DoH specialists to moonlight and have second jobs with pharmaceutical companies is unethical because it tends to corrupt the department, including the approval of new drug applications,” said Surigao del Sur Rep. Johnny Pimentel.
Pimentel is chairman of the House good government and public accountability committee, which recently concluded a joint inquiry with the health panel into the Dengvaxia controversy.
The two panels are now readying a report on their findings and recommendations, which may be released later this month.
In the course of their inquiry, the panels discovered that Ma. Rosario Capiding, chief of the microbiology department at the DoH Research Institute for Tropical Medicine (RITM), received P40,000 in monthly compensation from the vaccines division of Sanofi.
Capiding was the principal investigator of the study on Dengvaxia under a grant from Sanofi. The study commenced in 2011 and clinical trials were completed in 2017.
The results of the studies and clinical trials were then used to bolster Sanofi’s new drug application for Dengvaxia in the country.
“The RITM and its staff should not be conducting clinical studies and trials for and on behalf of pharmaceutical companies,” Pimentel said.
“The institute should be performing studies on its own on potential new vaccines or pharmaceutical agents. All its activities should be funded by the Philippine government alone, or by grants from disinterested parties,” Pimentel said.
Capiding defended herself by invoking Executive Order (EO) 674 – the RITM charter – issued by then President Ferdinand Marcos in 1981, and which supposedly allowed her to receive compensation from grants.
However, Pimentel said the “bad provisions” of EO 674 were considered automatically repealed by the Code of Conduct and Ethical Standards for Public Officials and Employees of 1989, or Republic Act 6713.