FDA cancels registration of trivalent oral polio vaccines

MANILA, Philippines - The Food and Drug Administration has cancelled the registration of all trivalent oral polio vaccines (tOPV) to comply with the World Health Organization (WHO)’s campaign to eradicate polio.

In an advisory, the FDA cancelled the certificates of product registration of four brands of tOPV.

These 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 FDA asked health professionals and establishments to stop prescribing and dispensing tOPVs.

The agency also directed its field regulation officers to ensure that the vaccines are taken off the market.

The Department of Health (DOH) had earlier issued a memorandum, mandating all health facilities nationwide to stop using tOPVs and dispose all remaining stocks of tOPV.

On April 27, the Philippines joined other countries in switching from tOPV to the bivalent type or bOPV.

The widespread use of tOPV spurred a global decrease in wild polio cases, with the wild poliovirus type 2 last seen in 1999, the DOH said.

The switch to bOPV follows the declaration of the eradication of the wild poliovirus type 2 in 2015.

The bOPV lacks the type 2 component, while tOPV contains the weakened versions of all poliovirus types (types 1, 2 and 3). The removal of the type 2 component enables better protection and lower risk from vaccine-related polio outbreaks.

The DOH’s regional offices will collect all remaining tOPV stocks and dispose them through encapsulation, a method approved by the WHO.

Encapsulation seals tOPV vials in cement, preventing further use or leakage. This also prevents type 2 polioviruses – even the weakened type in OPV – from circulating in the environment.