FDA permanently bans Dengvaxia

THE FOOD and Drug Administration (FDA) has permanently canceled the registration for anti-dengue vaccine Dengvaxia.

“We completely support the decision of the FDA to revoke immediately the certificate of product registration (CPR) of all Dengvaxia products,” Health Undersecretary Rolando Enrique D. Domingo told reporters on Tuesday.

FDA cited manufacturer Sanofi Pasteur’s repeated noncompliance in submitting post-approval commitment documents.

“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 the CPRs covering the Dengvaxia products,” FDA Director General Nela Charade G. Puno said in a statement on Tuesday.

As of December 17, 2018 , FDA’s Center for Drug Regulation and Research (CDRR) reported that Sanofi still did not comply with post marketing authorization requirements.

This led FDA to sign an order on December 21 that year for Sanofi to “immediately surrender the original CPRs of Dengue Tetravalent (Live Attenuated) (Dengvaxia MD) and Dengue Tetravalent (Live Attenuated) (Dengvaxia) upon receipt of the Order.”

Pursuant to the revocation, importing, selling, and distributing of Dengvaxia and Dengvaxia MD is illegal. Processing of any submission and application by Sanofi regarding the two Dengvaxia vaccines are also prohibited.

Mr. Domingo said, “The decision was made and communicated with the company last December 21 but I think for the FDA, normal course of business is tapos na (finished already) but we asked them to come up with an information to the public and that’s why they did it now.”

FDA had earlier suspended for one year the registration for Dengvaxia vaccines and ordered Sanofi to stop its distribution. —