Sanofi: We complied with int'l, local regulations on Dengvaxia

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Metro Manila (CNN Philippines, January 4) — French pharmaceutical company Sanofi Pasteur said it has complied with international and local laws and regulations in the rollout of its controversial dengue vaccine Dengvaxia.

In a statement, Sanofi said it will "continue to cooperate in full transparency with the Philippines FDA (Food and Drug Administration) and is committed to comply with the Philippines laws and regulations."

The FDA earlier notified Sanofi of the one-year suspension of Dengvaxia's marketing authorization, while the company was fined P100,000 over its failure to comply with regulations.

"According to the notification, this suspension is linked to an alleged failure to comply with post-marketing requirements and is not linked to the product profile," Sanofi said.

It added routine post-approval commitments are also conducted to ensure the safety and effectivity of the vaccines.

On November 29, 2017, Sanofi announced that Dengvaxia may cause "severe disease" to those immunized but have not been infected by dengue before.

In response, the FDA has suspended the sale and distribution of the dengue vaccine, while the Health Department suspended its national immunization program which uses Dengvaxia on students.

Health officials said about 800,000 students received the vaccine since the start of the P3.5-billion program on April 2016. It added it will return about P1.4 billion worth of Dengvaxia to Sanofi.

Both the Senate and House of Representatives are conducting separate probes on the issue, which have now involved former President Noynoy Aquino, and former Health Secretaries Janette Garin and Paulyn Ubial, among others.