Sanofi admits Dengvaxia not yet registered with EU drug authority

French pharmaceutical giant Sanofi Pasteur on Monday admitted that the controversial dengue vaccine Dengvaxia was not fully registered with the European Union (EU) drug authority when it was exported to the Philippines for its vaccination program. (Photo by Carol E. Davis via U.S. Army Corps of Engineers/Flickr, CC BY 2.0)

French pharmaceutical giant Sanofi Pasteur on Monday admitted that the controversial dengue vaccine Dengvaxia was not fully registered with the European Union (EU) drug authority when it was exported to the Philippines for its vaccination program.

At the resumption of the House hearing, Sanofi Pasteur head for Asia-Pacific Thomas Triomphe explained that the Dengvaxia license was already submitted to European Medicines Agency (EMA), the EU’s counterpart to the Philippine’s Food and Drug Administration (FDA).

Triomphe said that the registration was still pending with EMA when the vaccine was brought to the Philippines. However, he did not mention when they submitted their registration to EMA.

“Every single national regulatory agency decides on its own when to license another product. We have nothing to do in its process,” he stressed.

The head of Sanofi’s Asia-Pacific added that Dengvaxia was not a priority in Europe, but stated that the vaccine is licensed for use on people living in “endemic countries.”

According to Triomphe, the controversial vaccine is still in the process of certification. He said that its safety and efficacy were demonstrated before registration with EMA.

Iloilo Representative Ferjenel Biron pointed out that the Philippine government should not have allowed the use of Dengvaxia in the country as it was not 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 (If it is not registered in) Europe, what business do we have [in] importing this product here?” Biron asked.

Melody Zamudio, officer-in-charge of the FDA’s Center for Drug Regulation and Research, said the agency approves a lot of vaccines and medicines that were not registered with the country of origin, as long as they get through specific 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 sold. In this case there is no freely sold. But more than that, this certification, the certificate of pharmaceutical product, GMP, and free sale are part of the administrative documents being submitted to FDA,” Zamudio said.

“Other than these administrative documents, we have more requirements like requirements of quality, safety, and efficacy, and these have been satisfied,” she added.

On Monday, Sanofi declined a demand from the Philippine government to reimburse the entire P3.5 billion spent on its anti-dengue vaccines in 2016; however, the French firm has given back an initial of P1.16 billion refund last January for unused Dengvaxia vials.

The school-based vaccination was halted last year as the drug manufacturer revealed that the vaccine could lead to severe diseases if administered to people who have not been infected by the Dengue virus beforehand.