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Sanofi’s appeal to reverse ruling of FDA was denied.
The Department of Health (DOH) on Monday, August 19 permanently revoked the certificate of product registration (CPRs) of the controversial Dengvaxia anti-dengue vaccine due to Sanofi’s “continued failure to submit post-approval requirements.”
DOH said that in the middle of a nationwide dengue epidemic, Sanofi may reapply for new CPRs given that they comply with the laws.
Health Secretary Francisco Duque III also noted that the decision had nothing to do with the efficacy of the vaccine.
Sanofi, the holder of the CPRs of Dengvaixa and Dengvaxia MD, is bound by post-marketing commitments, including the submission of Risk Management Plans (RMP).
Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety, DOH explained.
It was found that the French manufacturer only submitted the first and second versions of its RMP. It has failed to submit the third version and tardily submitted the fourth version, in violation of its post-marketing commitments and pertinent Food and Drug Administration (FDA) rules and regulations.
While the Dengue Vaccine National Expert Panel advises Sanofi to submit “updated data on pharmacovigilance and post-marketing surveillance” to show the company’s progress in terms of monitoring and preventing the drug’s adverse effects for the more than 830,000 individuals vaccinated.
“The Department of Health is committed to a strong and strict implementation of our health laws and regulations. We know how critical this is to our efforts to rebuild public trust and confidence in our public health programs and in vaccines that have long been proven effective,” Duque stated.
DOH holds that the registration is up to FDA to act upon and that the department is currently focusing on response to dengue.
“We assure the public that the Department of Health has been working tirelessly in response to the nationwide dengue epidemic. We are intensifying the 4s strategy through our ‘Sabayang 4o-clock Habit’ and ensuring that our health facilities are adequately equipped to serve its patients,” Duque added.