In a follow-up on the Dengvaxia situation in the Philippines, the Food and Drug Administration (FDA) reports permanently revoking the Certificates of Product Registration (CPR) of dengue vaccine Dengvaxia for the continued failure of manufacturer Sanofi Pasteur, Inc. to submit post-approval commitment documents.
FDA Director General Nela Charade G. Puno pointed out that Sanofi has shown complete disregard of FDA 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 emphasized.
In the Order signed December 21, 2018 by Puno, the FDA ordered Sanofi to immediately surrender the Original CPRs of Dengue Tetravalent (Live Attenuated) Dengvaxia MD) and Dengue Tetravalent Vaccine (Live Attenuated) (Dengvaxia) upon receipt of the Order.
FDA pointed out that as of December 17, 2018, 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 FDA also reminded Sanofi that pursuant to the revocation of the CPRs, it is unlawful to import, sell, or distribute the said products.
The CDRR is also directed to defer the processing of any submission and application by Sanofi regarding Dengvaxia and Dengvaxia-MD.
The FDA initially suspended Dengvaxia’s CPR in 2017 with Sanofi directed to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA.
The move was done following adverse events or reactions were reported by the recipients following their immunization of the Dengvaxia vaccine.