Advisories

DOH - FDA WARNS PUBLIC ON BANNED POLIO VACCINE

DOH -  FDA WARNS PUBLIC ON BANNED POLIO VACCINE

Food and Drug Administration (FDA)  Director General Nela Charade G. Puno is reiterating her warning to the public to report to the FDA and the Department of Health (DOH) names of doctors who continue to dispense the banned Trivalent Oral Polio  Vaccine (tOPV).

The FDA cancelled the Certificates of Product Registration (CPR) last year of all manufacturers, importers and distributors of tOPV vaccines in line with the Order of the DOH for all health facilities nationwide to stop using tPOV to avoid the re-emergence of circulating vaccine-derived polio virus type 2. All remaining inventories of tOPV were also ordered destroyed.

"This type of vaccine has already been banned by the DOH and FDA since last year." Puno said. “In the light of recent reports that some private physicians continue to prescribe tOPV, we are calling on the public to be vigilant in the type of polio vaccine that is prescribed to their children.”

DOH Undersecretary Gerardo V. Bayugo pointed out in the order that the Polio Endgame Plan of the World Health Organization being supported by the DOH requires the removal of all oral polio vaccine in the long term,  beginning with the switch from trivalent OPV to bivalent oral polio vaccine (bOPV) since April of 2016. This was to remove the type 2 component from the immunization program.

The FDA subsequently issued an advisory June 2016 for the switch from tPOV to bPOV.

“We are alarmed at the disregard by these practitioners of the DOH Memo and the FDA directive banning the use of tPOV.  The distributors and retailers who continue to store this banned vaccine will be held criminally charged as well. This puts at risk public health and can compromise the global eradication of polio that we have been working for in the past decades.” Puno warned.

“Needless to say, we are coming after them with the full force of the law. The public must be vigilant as well. Do not give tPOV to your children,” Puno reiterated.

Director General Puno and Usec. Bayugo urged the public to report violators to the DOH and the FDA Hotlines:

DOH  Trunkline – (02) 651-7800

FDA  Trunkline -   (02) 857-1900

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