(Eagle News) — The Food and Drug Administration has permanently revoked the certificate of product registration of the controversial vaccine Dengvaxia.
The FDA made the announcement in a statement after Sanofi Pasteur, the drug manufacturer, admitted the vaccine could cause severe dengue in those who were administered the same and who have not had dengue beforehand.
Prior to Sanofi’s admission, over 800,000 schoolchildren were administered Dengvaxia under the government’s national immunization program launched during the time of then-President Benigno Aquino III.
Aquino, his former Health Secretary Janette Garin and former Budget Secretary Butch Abad face charges in connection with the program.
According to FDA Director General Nela Charade Puno, the decision was made after Sanofi failed to submit post-approval commitment documents despite being ordered to do so over a year ago.
“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty..,” Puno said.
According to the FDA, in its order on Dec. 21, 2018, it also ordered Sanofi Pasteur to surrender the original CPRs of Dengvaxia products.
With the revocation, the FDA said Sanofi Pasteur was now permanently banned from importing, selling or distributing Dengue Tetravalent (Live Attenuated), Dengvaxia MD and Dengue Tetravalent Vaccine (Live Attenuated) (Dengvaxia).
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