FDA permanently revokes Dengvaxia’s certificate of registration
MANILA, Philippines — The Food and Drug Administration (FDA) has permanently revoked the certificates of product registration (CPRs) it previously issued to Dengvaxia products after its manufacturer failed to submit post-approval commitment documents.
FDA Director General Nela Charade Puno on Tuesday cited French pharmaceutical firm Sanofi Pasteur, Inc.’s disregard of the agency’s rules and regulations as reason for the cancellation of its CPRs.
Sanofi Pasteur’s “brazen defiance of the 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 a statement.
According to FDA, it has ordered Sanofi Pasteur on December 21, 2018 to “immediately surrender” the original CPRs of Dengvaxia products – Dengue Tetravalent (Live Attenuated), Dengvaxia MD and Dengue Tetravalent Vaccine (Live Attenuated) (Dengvaxia).
Moreover, FDA said Sanofi Pasteur has yet to submit and comply with its post marketing authorization requirements as of December 17, 2018.
To recall, FDA initially suspended the CPR of Dengvaxia in 2017, and directed Sanofi Pasteur to halt the sale, distribution, or marketing of Dengvaxia.
Dengvaxia was also pulled out from the market pending compliance with the directives of FDA.
With the revocation of CPRs for Dengvaxia products, Sanofi Pasteur is prohibited from importing, selling or distributing Dengue Tetravalent (Live Attenuated), Dengvaxia MD and Dengue Tetravalent Vaccine (Live Attenuated) (Dengvaxia), FDA said.
The Center for Drug Regulation and Research was then instructed to defer the processing of any submission and application made by Sanofi Pasteur regarding Dengvaxia and Dengvaxia-MD due to the cancellation of its CPRs.
The Department of Health launched its anti-dengue inoculation drive in 2016, and administered Dengvaxia vaccine to over 830,000 adults and children in Central Luzon, Calabarzon, Metro Manila, and Cebu under the program.
Around a year later, Sanofi Pasteur issued a statement saying Dengvaxia vaccine may increase the risk of severe dengue in patients who received it without previous exposure to the mosquito-borne disease. /kga