MANILA (Reuters) - The Philippines has permanently halted the sale, distribution and marketing of Sanofi’s dengue vaccine in the country after the French drug maker failed to meet the directives of regulators.
Food and Drug Administration (FDA) Director General Nela Charade Puno said on Tuesday registration certificates for Dengvaxia products have been revoked because of Sanofi’s “brazen defiance” of the agency’s directives.
The FDA said Sanofi failed to comply with post marketing authorization requirements as of December last year.
Sanofi said it disagreed with the FDA’s findings.
“Sanofi Pasteur respectfully disagrees with the conclusions stated in the order and considers that the Philippines FDA has taken this decision despite our diligence, including the submission of documents from completed post-approval commitments and regular updates on the status of post-marketing studies,” the company said in a statement.
Sanofi, which filed a motion for reconsideration, said the agency had not questioned the safety and efficacy of Dengvaxia.
The product registration was first suspended in December 2017 after Sanofi warned that the Dengvaxia dengue vaccine could worsen the disease in some cases.
In late 2017, Sanofi said Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, triggering two congressional inquiries and a criminal investigation in the Philippines where 800,000 school-age children had already been vaccinated.
The government spent 3.5 billion pesos ($67 million) on a Dengvaxia public immunization program in 2016 to reduce the 200,000 dengue cases reported every year.
Michelle Lapuz, officer-in-charge of FDA’s legal department, said Sanofi can reapply for a product license but the company’s application would be “treated as high risk” given its history of non-compliance.
Reporting by Karen Lema, Additional Reporting by Matthias Blamont in Paris; Editing by Darren Schuettler