FDA orders withdrawal of dengue vaccine Dengvaxia from the market

The Food and Drug Administration (FDA) on Tuesday has ordered the French pharmaceutical company Sanofi Pasteur to suspend its distribution, sale, and marketing of the anti-dengue vaccine Dengvaxia in order to protect the general public, following the publication of the possible health risks of the vaccine.

“In order to protect the general public, the Food and Drug Administration (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,” the FDA said.

According to the agency, they are closely coordinating with the Department of Health (DOH) for any adverse events or reactions that may be reported by the recipients following their immunization of the Dengvaxia, and will immediately take appropriate measures to protect the public.

“All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post marketing surveillance of Dengvaxia, by reporting to FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person,” it said.

The government has earlier halted the dengue immunization program after Sanofi warned that according to a new clinical analysis, the said dengue vaccine is more harmful to individuals without prior dengue infections.

“For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection,” Sanofi said in a statement.

The Department of Health (DOH) spent P3.5 billion on the immunization program for one million public school children in the National Capital Region, Region 3, and Region 4A.