MANILA, Philippines (UPDATED) – The Department of Health (DOH) has permanently revoked the certificates of product registration (CPRs) of the controversial Dengvaxia anti-dengue vaccine because of manufacturer Sanofi Pasteur’s “failure to submit post-approval requirements.”
However, the DOH said the company may reapply for new CPRs in light of the ongoing national dengue epidemic, as long as it complied with the country’s laws.
The decision was made Monday, August 19, but relayed in a statement on Thursday, August 22. Health secretary Francisco Duque III said the decision had nothing to do with the efficacy of the vaccine but instead “concerns Sanofi’s complete disregard of Food and Drug Administration’s (FDA) regulations, which were precisely put in place by law to ensure safety.”
The FDA in February permanently revoked Dengvaxia’s CPRs, but the company appealed it.
The revocation means the vaccine can no longer be sold in the Philippines.
According to DOH, manufacturer Sanofi only submitted first and second versions of its risk management plans (RMP). RMPs are post-marketing requirements which ensure public safety.
The DOH added that the French drug manufacturing giant then failed to submit its third RMP and were tardy in turning in the fourth RMP.
The DOH also told the manufacturer to submit updated data on “pharmacovigilance and post-marketing surveillance” in order to show the company’s progress in monitoring the drug’s reported adverse effects to the over 830,000 students vaccinated through the 2016 Dengue immunization program in the National Capital Region (NCR), Central Luzon, and Calabarzon.
“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 also said. (READ: Post-Dengvaxia controversy: Paving the way forward for vaccines, health care)
‘Study possible remedies’
In a statement, Sanofi said it would study possible remedies available to the firm following the DOH decision. It also cited portions of the decision that showed the health department was not totally shutting its door to the company’s re-application for CPRs for Dengvaxia.”
“While we respectfully disagree with the cited violations that led to the decision denying our appeal on procedure, we are grateful to the DOH for recognizing that the ‘safety of Dengvaxia is not on trial,’ and for emphasizing ‘the dire need to have [a dengue vaccine] introduced or – in the case of Dengvaxia – reintroduced in the market,’” Sanofi said.
It also noted that the DOH while it “upheld the decision of the FDA that permanently revokes the certificate of product registration (CPR), we are grateful to the Department for providing clarity that “this [decision] is without prejudice to the re-application… for CPRs for Dengvaxia.”
“With this, we will thoroughly study all possible remedies available to us under Philippine laws and regulations while keeping in mind the best interest of the Filipinos,” Sanofi said.
The dengue vaccine has been included in the WHO 2019 List of Essential Medicines. The supporting data of our registration files have been validated by Philippine experts along with the WHO Strategic Advisory Group of Experts on Immunization (WHO-SAGE), the European Medicines Agency (EMA), the USFDA, and 20 other countries worldwide. We are confident in the public health value of this vaccine.
As a company that has been in the Philippines for over 50 years, we affirm our unyielding commitment to continue working with the Philippine government and local scientific and medical community to ensure that we all move forward in the fight against vaccine-preventable diseases.
The revocation of the CPRs comes amid calls for the vaccine to be made available even just to private practice doctors. Former health secretaries Esperanza Cabral and Janette Garin have both called on the health department to reconsider the vaccine.
President Rodrigo Duterte has also said that he would be open to the use of the vaccine amid the ongoing dengue epidemic, which has claimed 720 lives as of July 27.
But the DOH maintained that the vaccine has been proven not to be fit for an “outbreak response” and was not a mass immunization product. – Rappler.com
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