MAKING IT ILLEGAL | FDA permanently revokes Dengvaxia’s certificate of registration
3 weeks ago
FEBRUARY 19, 2019 — The Food and Drug Administration (FDA) has permanently revoked the Certificates of Product Registration (CPR) of dengue vaccine Dengvaxia after its manufacturer disregarded government regulations.
FDA Director General Nela Charade G. Puno pointed out that Sanofi Pasteur failed 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,” Puno said in a statement.
FDA said it has ordered 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.
But Sanofi has still not submitted and continued its failure to comply with its post marketing authorization requirements.
With the revocation of the CPRs, importation and distribution of the vaccine will make it illegal.
FDA also said any submission or application by Sanofi-Pasteur regarding the Dengvaxia and Dengvaxia-MD would be deferred.
The Aquino administration implemented the anti-dengue immunization program in 2016. Critics say the administration broke health protocols in testing an experimental drug on hundreds of thousands of young Filipinos.
The FDA initially suspended Dengvaxia’s CPR in 2017 following adverse events were reported after receiving the controversial vaccine.