Despite calls from several groups to allow the limited use of Dengvaxia amid the dengue epidemic, the Department of Health (DOH) announced on Thursday (August 22) that the appeal of Sanofi Pasteur seeking to reverse the revocation of its certificate of product registration (CPR) for the dengue vaccine has been thumbed down.
Health Secretary Francisco Duque III said the denial of Sanofi’s appeal dated August 19 was due to the French manufacturer’s “continued failure to submit post-approval requirements.”
Dengvaxia’s CPR was canceled by the Food and Drug Administration (FDA) last February, effectively banning the use of the vaccine in the country.
“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” Duque said.
He added: “The DOH is committed to strong and strict implementation of our health laws and regulations. We know how critical this is to our efforts to rebuild public trust and confidence in our public health programs and in vaccines that have long been proven effective.”
He, however, clarified that Sanofi can still apply for a new CPR for Dengvaxia, especially at this time when the country is in a state of national dengue epidemic, with the number of dengue cases about to breach 200,000 already this year.
Even President Duterte had said he is open to the use of Dengvaxia again. ”Now, compare it vis-à-vis to those who died, I want to hear the words of the experts, doctors, and we have enough bright people to tell us. I don’t need foreigners to tell me, my own Filipino scientists and doctors would tell me what to do. I will be guided by their announcements,” he said.
Sanofi failed to submit its third risk management plan (RMP), a post-marketing requirement meant to ensure public safety.
It also failed to submit fresh data on its “pharmacovigilance and post-marketing surveillance” programs.
These reports should detail the monitoring of Dengvaxia’s effects on some 830,000 students vaccinated through the Dengue Immunization Program at the tail end of the Aquino administration in 2016.