The Department of Health has upheld the permanent revocation by the Food and Drug Administration of the certificates of product registration of the anti-dengue vaccine Dengvaxia due to the continued failure of its manufacturer, Sanofi Pasteur Inc., to submit post-approval requirements.
While the decision had nothing to do with the vaccine’s efficacy, it reflects Sanofi’s “complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” Duque said.
As a holder of the certificates of product registration for Dengvaxia and Dengvaxia MD, Sanofi is bound by post-marketing commitments, including the submission of risk management plans, the Health secretary said.
“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” he said.
The DOH found that, while Sanofi has submitted the first and second versions of the risk management plan, it has failed to submit the third version, and has belatedly submitted the fourth version, in violation of its post-marketing commitments and pertinent FDA rules and regulations.
Duque said Sanofi has been informed that it may reapply for the certificates but must faithfully comply with all relevant laws, rules, and regulations.
The Dengue Vaccine National Expert Panel recommends Sanofi’s submission of updated data on pharmacovigilance and post-marketing surveillance.
This should show what the company has done in terms of monitoring and preventing the drug’s adverse effects for the more than 830,000 children that have already been vaccinated.
Public Attorney’s Office chief Persida Acosta welcomed the revocation of Sanofi’s certificates of product registration, saying it was expected, given the controversy surrounding the vaccine.
Acosta’s office has been representing the families of children who died after being given Dengvaxia.
Earlier, a group of physicians rejected the proposal to lift the ban on Dengvaxia, saying the vaccine would not address the ongoing dengue outbreak even as the number of infections continued to rise unabated. Dr. Julie Caguiat, one of five doctors representing various medical groups, slammed drugmaker Sanofi Pasteur for lying to the public when it introduced the anti-dengue vaccine to the Philippines.
Caguiat, secretary of the Community Medicine Practitioners and Advocates Association or Compass, said Sanofi has yet to publish the full result of its phase 3 trial or complete pre-planned subgroup analysis and the complete documents for phase 4.
“They lied to the people before. Why should physicians and the people trust them now?” Caguiat said.
Former Philippine Health Insurance Corp. director Anthony Leachon said eradicating the breeding places of mosquitoes and a massive cleanup of schools, workplaces and communities is more effective than vaccination with a “potentially dangerous vaccine.”
Another health expert, Dr. Antonio Dans, suggested that if the government is considering re-introducing Dengvaxia, it should be done properly this time.
Manila prohibited the import, sale and distribution of the drug after parents blamed it for the deaths of several dozen children who were among more than 700,000 people immunized in a state-run trial program.
After the Dengvaxia scare caused Filipinos to shy away from vaccines, the country was hit with measles and dengue outbreaks that have so far killed nearly a thousand people this year.
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