Sanofi fined P100,000; vaccine clearance on hold

The government has fined Sanofi P100,000 and suspended clearance for the French drug maker’s controversial dengue vaccine Dengvaxia, citing violations on product registration and marketing, Health Secretary Francisco Duque III said yesterday.

Concerns over the dengue immunization of nearly 734,000 children aged nine and above resulted in two congressional inquiries and a criminal investigation as to how the danger to public health came about.

The Food and Drug Administration (FDA) ordered Sanofi to stop the sale, distribution and marketing of Dengvaxia after the company last month warned the vaccine could worsen the disease in some cases.

“They were fined and their certificate of product registration was suspended,” Duque said.

The FDA also found Sanofi violating post-marketing surveillance requirements.

“Records and evidence clearly showed that respondent failed to comply with its post-marketing authorization issuance commitments, and that it has exhibited the propensity to not comply with this office’s regulatory requirements for its products, Dengvaxia and Dengvaxia MD,” the FDA said.

Sanofi was not immediately available for comment.

The government spent P3.5 billion for the Dengvaxia public immunization program in 2016 to reduce the 200,000 dengue cases reported every year.

The FDA earlier ordered the suspension of the sale of Dengvaxia after Sanofi admitted that the vaccine could cause more severe symptoms of dengue if administered on those who have not had the mosquito-borne illness before.

It also prompted lawmakers to launch a legislative inquiry into the matter wherein in one hearing, Sanofi claimed Dengvaxia remains to be “safe and efficacious.”

Former president Benigno Aquino III and his Cabinet officials, under whose time the immunization program was launched, are facing charges over the administration of the dengue vaccine on school children.

Appearing before a Senate inquiry, Aquino defended the procurement of the vaccine, saying there was a spike in the incidence of dengue nationwide. The availability of Dengvaxia presented an opportunity to save lives, he said, and he took it.

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