Dengvaxia permanently remains off the PH market

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Metro Manila (CNN Philippines, February 19) — The controversial dengue vaccine Dengvaxia would permanently remain off market shelves in the Philippines.

The Food and Drug Administration (FDA) permanently revoked the Certificates of Product Registration (CPR) to the dengue vaccine in contrast to the European Commission's approval of its sale  in December for countries afflicted with mosquito-borne disease.

A CPR is an authorization to sell a product to the public, Health Undersecretary Enrique Domingo told CNN Philippines.

In a statement Tuesday, FDA Director General Nela Puno said vaccine maker Sanofi-Pasteur disregarded government regulations. She said the French company failed to comply with post-marketing authorization requirements and, as a result, was ordered to surrender its CPRs for Dengue Tetravalent (live attenuated) (Dengvaxia MD) and Dengue Tetravalent Vaccine (live attenuated) (Dengvaxia) on December 21.

"Its brazen defiance of FDA's directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of CPRs," Puno said. 

The FDA decision means the sale, importation and distribution of the vaccines are considered "unlawful."  The drug regulator said any submission or application by Sanofi-Pasteur regarding the Dengvaxia and Dengvaxia-MD would be deferred.

In a statement, Sanofi-Pasteur said it "respectfully disagrees" with the FDA's conclusions in its order and has filed a motion for reconsideration.

"It is unfortunate that the FDA has taken this decision despite our diligence, including the submission of documents from completed post-approval commitments and regular updates on the status of post-marketing studies," the French pharmaceutical firm said.

It also noted that the FDA's order did not mention anything about the safety and efficacy of Dengvaxia. The FDA's press statement only said that the decision to permanently revoke the dengue vaccine's CPRs was done following reports of adverse effects experienced by Dengvaxia recipients.

"Dengvaxia clearly has the potential to play a public health role in the global fight against dengue and we will continue to work with health authorities to help secure access to the vaccine in countries where appropriate populations can benefit from vaccination against the disease," Sanofi-Pasteur said.

The vaccine was first withdrawn from the market after the manufacturer disclosed in late 2017 that Dengvaxia may cause "severe disease" among those who have not yet been infected with dengue. However, the announcement was made after around 800,000 schoolchildren had already been vaccinated with Dengvaxia under a massive government immunization program.

The Health Department eventually suspended the program.

TIMELINE: The Dengvaxia controversy

Over 100 deaths have been linked to the anti-dengue vaccine, but experts have said there are no findings that the drug has caused these deaths.

Officials of the Aquino and Duterte administrations, including former President Noynoy Aquino, former Health Secretary Janette Garin and Health Secretary Francisco Duque III, are facing graft and murder charges along with Sanofi-Pasteur executives over the anti-dengue vaccination drive.

The resulting panic over the controversy has been blamed for low immunization rates in the past months, which resulted in a number of measles outbreak. In 2015, The Philippines became the first Asian country to approve the use of Dengvaxia following Aquino and Garin's meetings with top-level Sanofi-Pasteur officials.

CNN Philippines Multi-platform Writer Xave Gregorio contributed to this report.