(Eagle News)–The Department of Health has upheld the Food and Drug Administration’s revocation of the Certificate of Product Registration of dengue vaccine Dengvaxia, but noted manufacturer Sanofi Pasteur may reapply.
In his decision on Aug. 19, Health Secretary Francisco Duque III said the efficacy of Dengvaxia itself was not an issue but Sanofi’s “complete disregard of FDA regulations, which were precisely put in place by law to ensure safety.”
The DOH said it found that while Sanofi submitted the first and second versions of the required Risk Management Plans, it failed to submit the third version, and “belatedly submitted the fourth version, in violation of its post-marketing commitments and pertinent FDA rules and regulations.”
“As a holder of the CPRs for Dengvaxia and Dengvaxia MD, Sanofi is bound by post-marketing commitments, including the submission of (RMP). Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” the DOH said.
According to the DOH, Sanofi has been informed that it may “re-apply for new CPRs, faithfully complying with all relevant laws, 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,” Duque said.
