Food and Drug Administration permanently bans Dengvaxia

MANILA, Philippines — The Food and Drug Administration (FDA) yesterday announced that the certificate of product registration (CPR) for the anti-dengue vaccine Dengvaxia has been “permanently revoked.”

According to FDA director general Nela Charade Puno, Dengvaxia manufacturer Sanofi Pasteur has “shown complete disregard of FDA rules and regulations” by its “continued failure... to submit post-approval commitment documents.”  

“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,” she said.

In December 2017, the FDA imposed a year-long suspension of Dengvaxia’s CPR after it failed to submit “post-marketing authorization requirements.”

As of Dec. 17, 2018, the FDA’s Center for Drug Regulation and Research (CDRR), in coordination with its Task Force Dengvaxia, found that Sanofi still has not complied with the requirements. 

Because of this, the FDA issued an order last Dec. 21, 2018 for 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.”

Puno added that with the permanent ban, “it is unlawful to import, sell or distribute the products” in the country.

For its part, the Department of Health (DOH) has welcomed the decision of the FDA, saying DOH really did not expect Dengvaxia to make a comeback.

“We’ve always agreed that will be the direction to go because we’ve always felt that the product that was sold to us was without complete information,” maintained DOH Undersecretary Eric Domingo in an interview.

He added the period for Sanofi to file an appeal has already lapsed.