FDA bans use of Dengvaxia vaccine

February 19, 2019

The Food and Drug Administration (FDA) Tuesday ordered the permanent ban of Sanofi Pasteur's dengue vaccine Dengvaxia.

In a statement, FDA director general Nela Charade Puno said they permanently revoked the certificates of product registration (CPR)  of Dengvaxia.

“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.

The FDA cited the failure of Sanofi Pasteur to submit post-approval commitment documents as the main reason.

“As of December 17, 2018, the 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,” said Puno.

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 suspension was done on the heels of reported adverse events among recipients following their receipt of the dengue vaccine.

The Department of Health (DOH) 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 Eric Domingo in an interview.

He said Sanofi Pasteur may appeal the FDA ruling.

He added that the FDA ruling does not mean that Sanofi Pasteur is  being blacklisted by the health department.

“It only covers Dengvaxia,” said Domingo. DMS