Sanofi denies hiding Dengvaxia risks from PH

Metro Manila (CNN Philippines, February 28) — French pharmaceutical company Sanofi Pasteur denied keeping information on the health risks of its dengue vaccine.

In a statement Wednesday, Sanofi said it disclosed to Philippine authorities the health hazards of Dengvaxia as soon as they had findings.

"Sanofi did not conceal any information... We learnt of the different product profile of the dengue vaccine for those with or without a previous dengue infection in November 2017," it said.

The vaccine maker described as "inaccurate" the information regarding the transparency of findings related to Dengvaxia.

The Food and Drug Administration (FDA) chief on Monday said Sanofi Pasteur was aware of Dengvaxia's health hazards months before November 2017.

FDA Director-General Charade Puno said documents from Singapore show Sanofi Pasteur was aware as early as October 2016 that the vaccine should not be administered to those without prior dengue infection.

"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 investigation on Dengvaxia.

She believes Sanofi was already aware of Dengvaxia's health risks when it applied for a CPR in the country in December 2015

"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 on Monday.

[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 Nov. 29, 2017 said new clinical data analysis showed those without previous dengue infection and got vaccinated with Dengvaxia could contract "severe disease."

The Aquino administration launched the nationwide Dengvaxia immunization program in February 2016.