FDA permanently revokes Dengvaxia’s product registration
The Food and Drug Administration (FDA) has permanently revoked the certificate of product registration of the controversial anti-dengue vaccine Dengvaxia over the "continued failure" of its manufacturer, French pharmaceutical giant Sanofi Pasteur to submit to the agency "post-approval commitment documents."
Sanofi's failure to comply, the agency said is a "complete disregard of FDA rules and regulations."
“Its brazen defiance of FDA’s directives and its con-
tinued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” said FDA Director General Nela Charade Puno in a statement.
“As of December 17, 2018, the Center for Drug Regulation 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,” added Puno.
The agency initially suspended the controversial vaccine’s certificate of product registration in 2017, directing Sanofi to suspend the sale/distribution/ marketing of Dengvaxia and cause the withdrawal of the vaccine in the market pending compliance with the directives of the FDA.
Pursuant to the revocation of the Dengvaxia's certificate of product registration, "it is unlawful to import, sell, or distribute the said products," the FDA said.
The Department of Health (DOH), meanwhile, welcomed the decision of the FDA.
“We’ve always agreed that that will be the direction to go because we’ve always felt that the product that was sold to us was without complete information,” said Health Undersecretary Rolando Enrique Domingo.
Domingo noted that Sanofi Pasteur may still appeal the ruling of the FDA.
In November 2017, Sanofi Pasteur announced that the Dengvaxia vaccine may pose potential health risk to patients not previously infected with dengue virus after about 800,000 schoolchildren had been inoculated. This prompted the DOH to suspend the school-based immunization program the following month.