'Why did Dengvaxia get FDA clearance without EU go signal?'
MANILA, Philippines – If it wasn’t cleared in its home country, why was it cleared in the Philippines?
A doctor who is also a member of the House of Representatives on Monday, February 5, questioned the Philippines’ Food and Drug Administration (FDA) allowed the registration of the now-controversial anti-dengue vaccine Dengvaxia when it wasn’t registered in its country of origin, France.
Iloilo 4th District Representative Ferjenel Biron, himself a physician, questioned why the FDA allowed the registration of the vaccine when it had yet to be vetted by the European Medicines Agency (EMA), a European Union agency responsible for evaluating medical products.
Biron, who noted that he was among those who crafted the 2009 law that created the FDA, pointed out that “no product should be allowed for export in the Philippines if it is not registered in the country of origin.”
The FDA’s Melody Samudio answered that in case a product was not registered in its country of origin, the agency then looks for proof that it is for export, on top of other requirements.
She noted that “there are a lot of medicines” – not just Dengvaxia – were not registered in their countries of origin but were approved for distribution in the Philippines. Samudio noted this was allowed so long as they pass other requirements, including quality and efficacy checks.
Thomas Triomphe, Asia Pacific head of Sanofi Pasteur, said the vaccine is already in the process of registration before the EMA. He noted that the French pharmaceutical submitted Dengvaxia for review in the respect drug agencies of various countries and that each country has its own process of evaluation and standards.
Biron also questioned by Sanofi produced Dengvaxia vials even before it was given a registration number in the Philippines. Triomphe himself confirmed that the products were repacked for Philippine distribution.
Again citing the rules of the FDA, Biron said registration should come before production.
Former FDA chief Lulu Santiago said that following Southeast Asian norms, manufacturers must produce at least 3 batches, including one of “commercial volume,” prior to product registration.
Santiago noted that “there is no restriction” on companies to later on sell commercial-sized batches used for validation “as long as they meet the requirements for the safety, quality, and efficacy.”
The procurement of the dengue vaccine, amounting to over P3.5 billion, is the subject of probes in both chambers of Congress. The mass immunization program, implemented under the Aquino administration, had earlier being contentious, amid the assertion of some medical experts that more clinical trials must be held before it is introduced to the public.
Late November 2017, Sanofi admitted that new clinical data showed the vaccine posed an increase risk for people who had yet to be infected by the virus before immunization. The data was the result of 6 years’ worth of clinical data.
The Philippines, under the Duterte administration, is now asking for a full refund of the P3.5 billion from Sanofi.
A University of the Philippines-Philippine General Hospital (UP-PGH) panel has been tasked by Health Secretary Francisco Duque III to conduct an independent analysis on the records of 14 vaccinated children who died due to various cases after participating in the vaccination program.
The Public Attorney’s Office (PAO) has also been conducting autopsies on children who were part of the vaccination program prior to their deaths.
A group of doctors, including a former health chief, has already called on the PAO to stop conducting autopsies and to let “competent forensic pathologists” determine the causes of the children’s death instead.
WATCH Monday's House hearing on the Dengvaxia controversy here. – Rappler.com