MANILA, Philippines — The Department of Health (DOH) has denied the appeal of French drug maker Sanofi Pasteur to lift the ban on the use of its anti-dengue vaccine in the country.
DOH said the permanent revocation of Sanofi’s Certificate of Product Registration for Dengavaxia was for its “continued failure to submit post-approval requirements.”
“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” Health Secretary Francisco Duque said in a statement.
The DOH stressed that while Sanofi managed to submit the first and second versions of its Risk Management Plans, the company had failed to submit its third version, and has belatedly submitted the fourth version.
This, according to DOH, is in violation of its post-marketing commitments and pertinent FDA rules and regulations.
“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” the health department said.
The DOH said Sanofi has already been informed and that it may re-apply for a new certificate of registration at the FDA.
The Dengue Vaccine National Expert Panel also recommended that Sanofi submit an updated data of its pharmacovigilance and post-marketing surveillance.
“The DOH 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,” Duque said.
“We assure the public that the DOH has been working tirelessly in response to the nationwide dengue epidemic. We are intensifying the 4s strategy and ensuring that our health facilities are adequately equipped to serve its patients,” he added. /muf