By Hannah Torregoza
A representative of French pharmaceutical company Sanofi Pasteur today agreed to shoulder the cost of any death or case related to the Dengvaxia vaccine they manufactured and marketed to the Philippine government.
This is on top of their earlier commitment to reimburse the government for the P1.4-billion unused vials of the anti-dengue vaccine after the Department of Health (DOH) issued demand letters against Sanofi.
“We have high ethics (standard) and obviously should there be any case related to vaccination, be death or any other case, we will shoulder the cost if there is a casualty that has been demonstrated through scientific evidence,” Thomas Triomphe, Sanofi’s Asia-Pacific head, told the Senate blue ribbon committee which Sen. Richard Gordon chairs.
“We will shoulder cost of any death or other event that is causally related to vaccination. Any or casually related to vaccination,” Triomphe reiterated at the resumption of the Senate’s hearing on the government’s controversial P3.5-billion worth of mass anti-dengue immunization program.
During the hearing, it was learned that the government did not follow the protocol in the approval of the Dengvaxia vaccines.
Senator Joseph Victor “JV” Ejercito noted that the Department of Health (DOH) under then Secretary Janette Garin’s watch implemented the mass vaccination of the Dengvaxia medicine and integrated it in the government’s national immunization program before the completion of Phase 3 of trials.
Ejercito noted the government started the anti-dengue drive sometime in April 2016, but the latter part of the Phase 3 trial is set in September 2017.
This was validated by Ma. Rosario Capeding, head of the microbiology department and dengue study group of the Research Institute for Tropical Medicine (RITM).
“Phase 3 of the clinical trial is not yet finished but the mass immunization program was already taking place,” Capeding told senators during the hearing.
Capeding said the Philippines is part of the five countries in Asia and Latin America that took clinical trial of Dengvaxia. In the country, the first phase started in June 2011.
She also said Sanofi is the one funding the clinical trials while they are in charge of surveillance case reports.
But Maria Lourdes Santiago, deputy director general for field regulatory operations office of the Food and Drug Administration (FDA), refuted the allegations saying that when Sanofi was given the go-signal the requirement for phase 3 clinical trials for product registration were fully met and actually submitted to the FDA.
“I think the study being referred to by Dr. Capedi was actually on the post approval efficacy studies that is actually part of the post approval commitment submitted to the FDA,” Santiago said at the hearing.
“In the record submitted to us the pivotal phase 3 trial conducted in Asia and started in June 2011 and the end date of the active phase after three dosages on immunization and one year of the hospital phase is on December 16, 2013. And that was actually in the record of the FDA—the result of safety and efficacy,” she said.
Sen. Risa Hontiveros, for her part, commended Sanofi for finally recognizing the need to compensate the children and families affected by the botched anti-dengue immunization program.
“Thank you very much Mr. Triomphe. Finally Mr. Chairman, we have, on the third and final attempt to ask this question, we have a final confirmation,” Hontiveros said.