THE Department of Health (DOH) has upheld the Food and Drug Administration’s (FDA) permanent revocation of the Certificates of Product Registration (CPR) of dengue vaccine Dengvaxia, thus affirming the ban since 2017.
DOH Secretary Francisco Duque III, however, informed Sanofi that it may re-apply for new CPRs, while faithfully complying 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 individuals vaccinated," said Duque.
In a decision dated August 19, said he has decided to junk the appeal of Dengvaxia manufacturer Sanofi Pasteur Inc. after its failure to submit post-approval requirements as required by law.
"The efficacy of the Dengvaxia itself is not in issue in this case. The decision concerns 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 CPRs for Dengvaxia and Dengvaxia MD, Duque said Sanofi is bound by post-marketing commitments, including the submission of risk management plans (RMP).
The DOH found that while Sanofi has submitted the first and second versions of the RMP, 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.
“The Department of Health is committed to 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,” said Duque.
"Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety," he added.
Back in 2017, the FDA suspended the CPR of Dengvaxia and subsequently revoked it last February after Sanofi revealed findings that its vaccine could cause severe dengue in individuals who were inoculated but have not contracted the virus.
Three weeks ago, Sanofi Pasteur filed an appeal before the Office of the Health Secretary as provided by existing rules, for the lifting of the ban.
Sanofi's appeal came amid the recent push for the reinstatement of Dengvaxia by several medical groups due to the recent declaration of a national dengue epidemic by the DOH. (HDT/SunStar Philippines)