FDA revokes Dengvaxia’s product registration permanently

The Food and Drug Administration (FDA) has permanently revoked the Certificates of Product Registration (CPR) of dengue vaccine Dengvaxia after its manufacturer Sanofi Pasteur, Inc. failed to submit post-approval commitment documents.

FDA Director General Nela Charade G. Puno said Sanofi had shown complete disregard for the agency's rules and regulations.

“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," Puno said.

In December 21 last year, Puno signed an order directing Sanofi to immediately surrender the original CPRs of Dengue Tetravalent (Live Attenuated) (Dengvaxia MD) and Dengue Tetravalent Vaccine (Live Attenuated) (Dengvaxia) as soon as the company receives the order.

As of December 17 last year, FDA said, its Center for Drug Regulation and Research (CDRR), in coordination with its Task Force Dengvaxia, confirmed that Sanofi has still not submitted and continued its failure to comply with its post marketing authorization requirements.

The agency reminded Sanofi that with the revocation of the CPRs, it is unlawful to import, sell, or distribute the said products.

Also in accordance with the revocation, the CDRR is also directed to defer the processing of any submission and application of Sanofi regarding Dengvaxia and Dengvaxia-MD.

In 2017, the FDA initially suspended Dengvaxia's CPR, directed Sanofi to stop the sale, distribution and marketing of Dengvaxia, and asked for the withdrawal of the vaccine in the market.

This, according to FDA, was after ‘adverse events or reactions were reported by the recipients following their immunization of the Dengvaxia vaccine.’

The dengue vaccine Dengvaxia became controversial as Sanofi announced in November in 2017 that it may lead to more severe symptoms of dengue for those who have never been infected by the virus prior to vaccination.

Since then, the Department of Health (DOH) stopped the school-based dengue immunization program using Dengvaxia.

It also became a subject for investigation after allegations were raised that it caused deaths of several children who were administered with the vaccine. —NB, GMA News