Dengvaxia’s certificates of product registration (CPRs) have been “permanently revoked,” the Food and Drug Administration (FDA) announced Tuesday, February 19. This is due to the continued failure of the anti-dengue vaccine manufacturer, Sanofi Pasteur Inc., to submit post-approval commitment documents.
According to FDA Director General Nela Charade Puno, Sanofi Pasteur has “shown complete disregard of FDA rules and regulations” which was the reason for the cancellation of Dengvaxia’s CPRs.
“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.
Puno added that with the revocation of the Dengvaxia’s CPRs, “it is unlawful to import, sell or distribute the products” in the country.
Dengvaxia’s CPRs were first suspended in December 2017. The FDA imposed a year-long suspension after its failure to submit “post-marketing authorization requirements.”
A year later, Sanofi still had not complied with the requirements, leading to an order released by the FDA on Dec. 21, 2018 for the company 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.”
Dengvaxia’s permanent ban was welcomed by the Department of Health (DOH), saying it really did not expect Dengvaxia to make a comeback.
DOH Undersecretary Eric Domingo, in an interview, maintained that they have “always agreed that will be the direction to go” because they have always felt that “the product that was sold to us was without complete information.”
He also said that the period for Sanofi to file an appeal has already lapsed.