French pharmaceutical giant Sanofi-Pasteur has admitted that the controversial Dengvaxia anti-dengue vaccine had not been registered with the European Medicines Agency.
The firm’s Asia Pacific head Thomas Triomphe made the admission during a House inquiry into the purchase of some 3.5-billion pesos worth of vaccine today (Monday, February 5).
Mr Triomphe stressed that although the vaccine’s registration remained pending, its “safety and efficacy have been demonstrated”.
Congressman Ferjenel Biron said “Sanofi had no business to distribute it in the Philippines” since the vaccine had not been registered with the country of origin.
However, Maria Lourdes Santiago, director of the Philippines’ Food and Drug Administration (FDI), said the vaccine satisfied the requirements for validation so it was given clearance for marketing in the Philippines.
The FDA said Dengvaxia was approved based on the World Health Organisation’s recommendation and International Conference on Harmonisation’s guidelines 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 vaccine.
He said these patients were injected with Dengvaxia and subsequently died of dengue within 30 days.
Mr Triomphe said there was no direct evidence linking Dengvaxia to any deaths. He also maintained that using Dengvaxia would ensure less dengue cases in the Philippines than not using it.
He added that Sanofi-Pasteur would not refund the 1.8 billion pesos cost of used Dengvaxia vaccines because “doing so will imply the product is ineffective”.
Sanofi has already reimbursed to DOH 1.16 billion pesos for the unused doses.
DOH Secretary Francisco Duque also raised concern over the impact of the Dengvaxia controversy to other vaccine programmes of the government.
“It has indeed tainted the entire DOH immunisation program,” he lamented.
Under the administration of former President Benigno Aquino 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 in April 2016.
The DOH has since suspended the immunisation drive, after Sanofi conceded that Dengvaxia could worsen symptoms for vaccinated children who contracted the disease for the first time.
More than 800,000 Filipino children had already received shots by the time the DOH suspended the programme.