Food and Drug Administration may decide on sale of Dengvaxia

MANILA, Philippines — Whether the controversial anti-dengue vaccine Dengvaxia will be made available in the local market again is likely to be known today.

Health Undersecretary Eric Domingo said the Food and Drug Administration (FDA) is set to meet today and may decide on whether to grant a certificate of product registration (CPR) for Dengvaxia.

“I was informed by FDA that they will meet Dec. 21 and may probably decide then,” Domingo said.

If the French drug manufacturer Sanofi Pasteur is able to secure a CPR, Domingo said, Dengvaxia would be available again in drugstores and pharmacies in the country.

Sanofi reported that last October, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) had approved the use of the dengue vaccine in European endemic areas.

However, Domingo said, the Department of Health (DOH) is no longer resuming the dengue immunization campaign even if the FDA grants CPR for Dengvaxia.

“Dengvaxia is no longer included in the DOH’s immunization program,” Domingo said.

The FDA suspended the CPR of Dengvaxia shortly after Sanofi officials admitted that the vaccine posed serious health risk to those who were not previously infected with dengue.

The FDA also noted that the Dengvaxia manufacturer failed to comply with post marketing authorization requirements after securing the CPR.

Health Secretary Francisco Duque III also suspended the Dengvaxia immunization program after a number of deaths were linked to the anti-dengue vaccine. About 800,000 school children have been vaccinated during the immunization campaign.

Sanofi agreed to refund P1.16 billion for the unused doses of Dengvaxia.