THE Food and Drug Administration (FDA) has ordered the recall of a controversial dengue vaccine from the market because of the health risk it poses to its recipients.
“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,” according to the advisory issued late Monday.
The FDA statement was issued hours after Sanofi Global Medical Head Ng Su-Peing said there was no notice from regulatory bodies to recall Dengvaxia.
The advisory also directed Sanofi to conduct an information dissemination campaign through advisories, Dear Doctor Letters and patient fora.
Sanofi is in hot water after admitting that the dengue vaccine, which has been administered to more than 700,000 individuals over the years may cause a more severe case of dengue for first-time patients. KENNETH HERNANDEZ