8/24/2016

FDA cancels registration of oral polio vaccines



 Friday, August 19, 2016 

THE Food and Drug Administration (FDA) has ordered the cancellation of registration of all trivalent Oral Polio Vaccines (tOPV) present in the market as part of the comprehensive polio endgame strategy adopted by the World Health Organization (WHO).
Based on FDA Advisory No. 2016-087, they have already cancelled the Certificates of Product Registration (CPRs) of four brands of tOPVs present in the market.
The four are Live Attenuated Trivalent Oral Polio Vaccine (Sabin Strains) with brand name Polioral Trivalent Vaccine; Live Attenuated Trivalent Oral Polio Vaccine with brand name Opvero; Oral Poliomyelitis Vaccine Type 1,2,3 with brand name Opvero; and Live Attenuated Trivalent Oral Polio Vaccine.
“The withdrawal from the market of the abovementioned vaccines [has] already started,” said the FDA.
According to the FDA, the cancellation of registration is spurred by the decision of the WHO to call for the removal of all oral polio vaccines (OPVs) in a phased manner, from both routine programmes and campaigns, to minimize the risk of new polio cases.
It aims to complete the interruption of wild poliovirus transmission globally and more rapidly detect and interrupt any new outbreaks due to vaccine-derived polio viruses.
In turn, the Department of Health (DOH) issued Department Memorandum (DM) No. 2016-0146, which states that all health facilities nationwide should stop using tOPV and dispose all remaining stocks of tOPV.
“Ongoing use of tOPV after the switch day may threaten or postpone the global eradication of polio,” said the DOH memorandum.
The FDA, then, called on all concerned health workers and establishments to stop prescribing, dispensing, and using any of the mentioned tOPVs.
All Officers of the Field Regulatory Operations Office (FROO) of the FDA are also directed to make sure that the concerned vaccines are withdrawn from the market. (HDT/Sunnex)
Post Polio Litaff, Association A.C _APPLAC Mexico

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