MANILA — The anti-dengue vaccine Dengvaxia had not been registered with the European Medicines Agency, the counterpart of the Philippines’ Food and Drug Administration (FDA), prior to its distribution in the country.
Asia Pacific head of French pharmaceutical firm Sanofi Pasteur Thomas Triomphe made the admission on Monday during the House inquiry into the controversial purchase of some PHP3.5-billion worth of Dengvaxia vaccines during the previous administration.
Triomphe stressed that while the vaccine’s registration remains pending, its “safety and efficacy have been demonstrated.”
Iloilo Rep. Ferjenel Biron said that “Sanofi had no business to distribute it in the Philippines” since the vaccine had not been registered with the country of origin.
For her part, FDA OIC Director Maria Lourdes Santiago, who was also present during the hearing, said the anti-dengue vaccine satisfied the requirements for vaccine validation so it was given clearance for marketing in the Philippines.
FDA said Dengvaxia was approved based on the World Health Organization’s recommendation and the International Conference on Harmonization (ICH) guideline for the evaluation of vaccines.
During the same hearing, Department of Health (DOH) Undersecretary Enrique Domingo said three cases of the 14 examined deaths had “causal association” to the Dengvaxia vaccine.
Domingo said these three patients were injected with Dengvaxia and subsequently died of dengue within 30 days.
Triomphe said there is no direct evidence linking Dengvaxia to any deaths. Triomphe also maintained that using Dengvaxia will ensure less dengue cases in the Philippines than not using it.
Triomphe said Sanofi-Pasteur would not refund the PHP1.8 billion cost of used Dengvaxia vaccines because “doing so will imply the product is ineffective.”
Sanofi has already reimbursed to DOH the amount of PHP1.16 billion for the unused doses of Dengvaxia.
DOH Secretary Francisco Duque also raised concern over the impact of the Dengvaxia controversy to other vaccine programs of the government.
“It (Dengvaxia) has indeed tainted the entire DOH immunization program,” Duque said.
Under the administration of former President Benigno “Noynoy” Aquino III and former Health Secretary Janet Garin, the Philippines became the first country in the world to launch in April 2016 a public inoculation plan against dengue using Dengvaxia.
The DOH has since suspended the anti-dengue immunization drive, after Sanofi conceded that Dengvaxia could worsen symptoms for vaccinated children who contracted the disease for the first time.
More than 700,000 Filipino school children had already received Dengvaxia shots by the time the DOH suspended the immunization drive. (Filane Mikee Cervantes/PNA)
