The Department of Health announced yesterday that it has denied the appeal of French pharmaceutical firm Sanofi Pasteur to restore the registration of the Dengvaxia anti-dengue vaccine, citing the company’s “continued failure to submit post-approval requirements.”
The DoH said that it has decided to “uphold” the decision of the Food and Drugs Administration last February to permanently revoke the Certificates of Product Registration of the Dengvaxia vaccine.
“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,” said Health Secretary Francisco Duque III.
The DoH said that Sanofi has failed to submit its third version of its “Risk Management Plan” and “belatedly submitted” the fourth version of the RMP. The RMP is part of the post-marketing requirements.
“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” said Duque.
“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,” the Health chief added. (Analou de Vera)
