GENEVA — The World Health Organization (WHO) supported a decision by the Philippines Department of Health on Tuesday to suspend vaccinations with Sanofi’s dengue drug Dengvaxia, it said in a statement.
“Like many others in the Philippines, WHO is awaiting the expert analysis of new data and advice about its implications for use of the vaccine,” it said.
“In the meantime, WHO supports the Philippines Department of Health’s decision to suspend the ongoing vaccination program until more information is available. This is appropriate in the circumstances,” WHO added.
Last Tuesday, the Food and Drug Administration of the Philippines ordered the French pharmaceutical giant to stop the sale and distribution of Dengvaxia “to protect the general public” from health risks associated with the world’s first anti-dengue vaccine.
FDA Advisory No. 2017-318 “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 agency.
“Sanofi was further directed to conduct an information dissemination campaign through Advisories, Dear Doctor Letters and Patient fora,” the FDA further noted in its advisory.
In an advisory issued last November 29, Sanofi said that based on post-clinical trial study, it was found that Dengvaxia posed potential risk to patients who have not had dengue prior to immunization.