After Sanofi Pasteur, a pharmaceutical company, admitted in November 2017 that their so-called vaccine against dengue could cause severe dengue if given to those who have not had the disease, the government, under Health Secretary Francisco Duque III, suspended its dengue vaccination program. This inoculation program happened during under the Aquino administration who. However, Aquino denies liability over this national problem.
Speaking before a Senate hearing in 2017, Duque said Sanofi was being deceitful about the risks of Dengvaxia. “We should not allow this. We’re talking about the lives of people here. We’re talking about the lives of our children,” the Health Secretary said.
In relation to this, the Certificate for Product Registration (CPR) for this vaccine had also been suspended for one year. The suspension was ordered on December 29, 2017, after the Food and Drug Administration (FDA) declared that the said pharmaceutical company had failed to comply with their post-marketing requirements. Since then, the company suspended the distribution, sale, and the marketing of the said dengue vaccine.
Today, the FDA has permanently revoked the CPR of the vaccine Dengvaxia. According to the statement released by the FDA’s Director General Nela Charade Puno, “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.” In addition, Puno also stated that “the pharmaceutical company has shown complete disregard of government rules and regulations”.
FDA ordered Sanofi to surrender the original CPRs of the two infamous vaccines, the tetravalent (Dengvaxia MD) and dengue tetravalent vaccine (Dengvaxia) upon receipt of order. The FDA’s Center for Drug Regulation and Research has been directed to defer any submission and application of Sanofi in relation to Dengvaxia and Dengvaxia MD. It also reminded the pharmaceutical company that “pursuant to the revocation of the CPRs, it is unlawful to import, sell, or distribute the said products”.
On the other hand, the pharmaceutical Sanofi Pasteur insists that it will not grant a refund for the Department of Health’s (DOH) purchased of Dengvaxia vaccines. They also decline to give compensation to their victims. Regarding these issues, Sanofi Pasteur released the statement:
“As we did in our previous reply to the DOH on February 5, 2018, we respectfully declined both requests to refund the government for the used doses of Dengvaxia and finally support an indemnification fund. We stand firmly behind our product. Refunding the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case. And at this time, there is no known circumstance requiring indemnification. We also again made very clear our willingness to sit down with the DOH to find other ways we can assist their efforts to combat dengue in the Philippines and restoring public trust in vaccines.”
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