FDA: Sanofi already knew of Dengvaxia risks as early as 2015

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Metro Manila (CNN Philippines, February 26) — The Food and Drug Administration (FDA) chief on Monday revealed drug maker Sanofi Pasteur was aware of the health hazards of the controversial Dengvaxia months before the launch of the nationwide immunization program.

FDA Director-General Charade Puno said documents from Singapore show that Dengvaxia manufacturer Sanofi Pasteur was already aware in October 2016 that the vaccine should not be administered to those who have not yet contracted dengue.

"We visited some of the documents of Singapore recently. If you will check on their publication, they approved the Dengvaxia CPR (Certificate of Product Registration) October 2016. With their publication, they announced that it is not to be used for patients who hadn't had dengue," she said during the House panels' investigation into the Dengvaxia mess.

She believes, when the Philippines applied for CPR in December 2015, Sanofi was already aware of the health risks.

"Alam nila. Dapat [noong] December 22, 2015, alam na nila at dapat sinabi na nila sa Pilipinas na hindi ito puwede sa mga batang 'di pa nagkakaroon ng dengue," she said during the House panels' investigation into the Dengvaxia mess.

[Translation: They knew about it. When they knew about it on December 22, 2015, they should have informed the Philippines it shouldn't be administered to children who has not contracted dengue.]

Sanofi on November 29, 2017 said new clinical data analysis showed those not previously infected with dengue and got vaccinated with Dengvaxia could contract "severe disease."

The Philippines, under then-Health Secretary Janette Garin, launched the nationwide Dengvaxia immunization program in February 2016.

Special treatment?

Puno also said former Center for Drug Regulation and Research director Benjamin Co gave special treatment to Sanofi.

The FDA chief explained Co personally received a USB drive from Sanofi containing its application to be allowed to sell their vaccine in the Philippines.

"I presumed that Dr. Benjie Co was doing his job in closely monitoring the submission of the post marketing reports [of Sanofi]. What happened was we had to investigate and we found out several issues wherein there's doubt in terms of submissions or entertaining or accommodating Sanofi," she said.

Co, who was removed his post on February 21 pending the Dengvaxia investigations and reassigned to Puno's office, was not invited to the hearing.

CNN Philippines' Joyce Ilas contributed to this report.