MANILA - The controversial dengue vaccine Dengvaxia was not yet registered with the European Union drug authority when it was used to vaccinate kids in the Philippines, French drug-maker Sanofi Pasteur admitted Monday.
Thomas Triomphe, Asia-Pacific head of Sanofi Pasteur, explained that Dengvaxia, which was produced for countries with high cases of dengue, was not a priority in Europe.
"Every single national regulatory agency decides on its own when to license another product. We have nothing to do in its process... Looking at the geographic situation of France and the borders of France it is not a priority by the European Union," he said in a hearing by a House of Representatives committee.
Dengvaxia is still in the process of certification, said Triomphe. He stressed that its safety and efficacy has been demonstrated sans registration with the European Medicines Agency, the EU's equivalent to the Philippines' Food and Drug Administration.
Iloilo Rep. Ferjenel Biron said the Philippines should not have accepted Dengvaxia as it has not even been approved by the European FDA.
"We're talking of a product, a biological product which safety and efficacy has not been established even from the country of origin... Kung hindi siya rehistrado sa Europe what business do we have importing this product here?" he pointed out.
The FDA said the agency approves a lot of vaccines and medicines that have not been registered with the country of origin, as long as they pass certain standards and requirements.
"Not only vaccines but medicine in general that we approved if there is proof of Good Manufacturing Practice compliance and are freely zoned," said FDA's Melody Samudio.
"Other than these administrative documents, we have more requirements like requirements of quality, safety, and efficacy, and these have been satisfied."