FDA revokes Dengvaxia certificate

The Food and Drug Administra­tion (FDA) has permanently re­voked the certificate of product registration of the controversial anti-dengue vaccine Dengvaxia.

The FDA said on Tuesday that it revoked the product registration of Dengvaxia due to the “continued failure” of its manufacturer, French pharmaceutical giant Sanofi Pas­teur, to submit to the agency “post-approval commitment documents.”

The agency said that Sanofi’s failure to comply is a “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,” 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, with Sanofi directed 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. (Analou de Vera)