Sanofi defends dengue vaccine following FDA sanctions


Posted at Jan 04 2018 09:13 PM

MANILA - French drug-maker Sanofi Pasteur on Thursday defended its controversial dengue vaccine, saying it has complied with Philippine laws and regulations and would continue to do so.

This after the Food and Drug Administration (FDA) suspended its Dengvaxia vaccine's certificate of product registration for a year and fined Sanofi P100,000 for failure to comply with regulations. 

"Sanofi Pasteur confirms that in accordance with international and local laws, regulations and company standards, post-approval commitments for Dengvaxia, as described in the pharmacovigilance (drug safety) plan submitted to the Philippines FDA and other national regulatory authorities, have been and will continue to be fulfilled," the company said in a statement.

The company added that the pharmacovigilance plan for the Dengvaxia vaccine is the same in all countries where its use has been approved. 

Sanofi also clarified that the FDA suspension order is due to their company's supposed failure to comply with post-marketing requirements and not due to the vaccine's "product profile."

"As part of our standard company practices, Sanofi routinely conducts post-approval commitments to continuously evaluate the safety and effectiveness of our vaccines in the countries where they are in use, and we have done so in the Philippines with Dengvaxia," the drug-maker said.

The dengue vaccine earlier triggered a health scare among Filipinos after Sanofi admitted that the drug could cause more severe symptoms of dengue if administered on those who have not had the mosquito-borne illness.

Sanofi's admission prompted the FDA to suspend the sale of Dengvaxia. The government also suspended its nationwide dengue immunization program, under which some 830,000 children were injected with the drug.

It also prompted lawmakers to launch a legislative inquiry into the matter.