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MANILA – The Health Ministry said Thursday it has rejected the appeal of French drug maker Sanofi Pasteur to overturn a regulatory decision effectively banning the use of its dengue vaccine in the Philippines.
The Health Department stated that it was maintaining the permanent revocation of the product registration certificate for Dengvaxia for "continuing non-compliance with the requirements after approval".
"The decision concerns Sanofi's total non-compliance with FDA regulations, which were specifically put in place by law to ensure safety," said Health Secretary Francisco Duque. The decision was dated August 19th.
Sanofi may re-apply for a FDA registration certificate, according to the DOH, which said the agency "is focusing" on its response to the national dengue epidemic.
Sanofi has not submitted the third and final risk management plan or PGR for the drug, which was recalled late 2017 for security reasons, the DOH said.
"Since dengvaxia is an innovative medicine, it is essential to meet these post-market commitments for public safety," he said.
The national expert group on dengue vaccines urged Sanofi to submit updated data on pharmacovigilance and post-market surveillance, the DOH said.
"This should show what the company has done in terms of monitoring and preventing adverse drug reactions for more than 830,000 people vaccinated," he said.
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