Press Release/22 August 2019
The Department of Health (DOH), in a decision dated 19 August 2019, has upheld the Food and Drug Administration’s (FDA) permanent revocation of the Certificates of Produce Registration (CPRs) of dengue vaccine Dengvaxia due to the continued failure of manufacturer Sanofi Pasteur, Inc. to submit post-approval requirements.
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,” Health Secretary Francisco T. Duque III said.
As a holder of the CPRs for Dengvaxia and Dengvaxia MD, Sanofi is bound by post-marketing commitments, including the submission of Risk Management Plans (RMP). Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety.
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,” the Health Chief added.
In the midst of a nationwide dengue epidemic, Sanofi has been informed that it may re-apply for new CPRs, 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.
DOH maintains that the registration of Dengvaxia is for FDA to act upon and that the DOH is currently focusing on response to dengue.
“We assure the public that the Department of Health has been working tirelessly in response to the nationwide dengue epidemic. We are intensifying the 4s strategy through our ‘Sabayang 4o-clock Habit’ and ensuring that our health facilities are adequately equipped to serve its patients,” Secretary Duque added.