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Philippines' FDA suspends Dengvaxia marketing, Sanofi responds

Published on 05/01/18 at 11:40am

As the Dengvaxia scandal in the Philippines rolls into 2018, it emerges that the country’s Food and Drugs Administration has suspended clearance for the Sanofi vaccine for a year, after concerns over its safety flared following a recent follow-up study which revealed that dengue-naïve patients receiving the therapy could face a life-threatening reaction if they were to contract the virus after administration.

Sanofi was also hit with a largely symbolic fine of 100,000 Philippine pesos, or $2,000, in response to their vaccination of almost 734,000 children under the age of nine with the treatment, as part of the Philippine Government’s P3.5 billion immunisation programme. As a result of the move by the Philippines FDA, the company is forbidden from selling, distributing or marketing Dengvaxia in the country.

But the French drugmaker stressed that the move was not due to safety concerns related to the vaccine, and was instead due to Sanofi’s failure to comply with post-marketing authorisation requirements.

"On December 29th, the Philippines Food and Drug Administration (FDA) notified Sanofi Pasteur of a one-year suspension of Dengvaxia Marketing Authorization. According to the notification, this suspension is linked to an alleged failure to comply with post-marketing requirements and is not linked to the product profile,” the company said in a statement. "As part of our standard company practices, Sanofi routinely conducts post-approval commitments to continuously evaluate the safety and effectiveness of our vaccines in the countries where they are in use, and we have done so in the Philippines with Dengvaxia."

This was corroborated by the FDA itself, which said in a statement: “Records and evidence clearly show that Respondent failed to comply with its post-marketing authorisation issuance commitments, and that it has exhibited the propensity to not comply with this Office’s regulatory requirements for its products, Dengvaxia and Dengvaxia MD.” The regulator had called for marketing suspension of Dengvaxia on 4 December, 2017.

Sanofi has confirmed it will now comply to the requirements imposed by the Phillipine regulator, noting in a statement: “Sanofi Pasteur will continue to cooperate in full transparency with the Philippines FDA and is committed to comply with the Philippines laws and regulations.”

Matt Fellows

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