Philippines Revokes Sanofi Product License for Dengue Vaccine

MANILA (Reuters) – The Philippines has permanently stopped the sale, distribution and marketing of Sanofi's dengue vaccine in the country after the French drug maker failed to comply with regulatory guidelines.

Food and Drug Administration (FDA) Executive Director Nela Charade Puno said on Tuesday that Dengvaxia's product registration certificates had been revoked due to Sanofi's "insane challenge" to the agency's guidelines.

The FDA has stated that Sanofi has not complied with the requirements for post-marketing authorization as of last December.

Sanofi disagreed with the FDA's findings.

"Sanofi Pasteur respectfully disapproves of the findings set out in the order and considers that the FDA of the Philippines has made this decision despite our due diligence, including the submission of documents resulting from the post-approval commitments completed and regular updates on the State 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 dengvaxie.

The product registration was suspended for the first time in December 2017 after Sanofi warned that the dengue fever vaccine could worsen the disease in some cases.

At the end of 2017, Sanofi said that dengvaxia could increase the risk of severe dengue in children never exposed to the virus, triggering two congressional investigations and a criminal investigation in the Philippines, where 800,000 school-aged children had already have been vaccinated.

The government spent 3.5 billion pesos ($ 67 million) on a public immunization program against dengvaxia in 2016 to reduce the 200,000 dengue cases reported each year.

Michelle Lapuz, head of the FDA's legal department, said that Sanofi could re-apply for a product license, but that the company's request would be "treated as a high risk" given its history of non-compliance.