FDA orders Dengvaxia pulled out of market

December 5, 2017

The Food and Drug Administration (FDA) has ordered Sanofi Pasteur to stop selling Dengvaxia vaccine and ordered it pulled out of the market.

According to FDA Advisory No. 2017-318, issued late Monday, the FDA said: "In order to protect the general public, the FDA immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA."

FDA said this follows the latest advisory by Sanofi on potential adverse effect of the dengue vaccine.

"The advisory contained information on the completion of a post-clinical trial study of the said product indicating potential risk to patients who have not had dengue prior to immunization," said FDA.

Last week, the health department ordered a halt to its mass dengue vaccination program, where 733,713 children from National Capital Region, Calabarzon, and Central Luzon were given shots.

Health Secretary Francisco Duque III said individuals will be held accountable over the dengue vaccine issue.

Duque said there will be an extensive probe on who should be held liable for the dengue vaccine program given the latest advisory issued by its manufacturer, Sanofi Pasteur.

"Once it is proven that there were information that were not fully disclosed but were factors in these latest developments, someone will surely be held accountable," said Duque in a radio interview. "There will be cases filed." DMS