Although Moderna boosters have been approved in the US, in the Philippines it is still awaiting emergency use authorization (EUA) to fight the raging Omicron variant.
The newly- developed Moderna booster shots against the Omicron variant of the coronavirus are pending approval by the Department of Health and the Inter-agency Task Force on the management of emerging infectious diseases to boost the local supply of this vital vaccine.
Rep. Angelica Natasha Co of the Barangay Health Workers Partylist citing news reports of Moderna submitting its updated booster vaccines for emergency use authorization (EUA) by the US Food and Drug Administration and the Biden-Harris administration are being readied for rollout once the FDA had given its approval.
“Current stocks remain relevant, useful, valid, and effective against COVID of whatever variant because they keep many people from getting severe or critical symptoms and prevent most patients fromhospitalization.”Co said.
Co recalled that when COVID vaccines became available in 2020, she anticipated that DOH and IATFhave learned lessons from earlier efforts to procure them. She said that she is not worried about the reported vaccine waste and expiration because those represent small portions of the overall supply in the nation and are within the expected range for vaccine wastage rates.
“Nariyan pa po ang banta ng COVID lalo na ang Omicron variant at subvariants nito na siyang dominant strain ng coronavirus na patuloy na kumakalat. Dagdag problema pa ang monkeypox at ang naantalang basic vaccination programs mula 2020 hanggang ngayon dahil sa community quarantines alert level 2, level 3, at hard lockdowns,” Rep. Co said.
“Sana naman kasama sa rekomendasyon ng DOH at IATF kay Pangulong Marcos na kung hanggang December 31 lang ang state of calamity o public health emergency, ilabas na ng Food and Drug Administration ang provisional o full approval ng certificate of product registration para sa COVID vaccines. Unahin na nila ang CPR ng Moderna at Pfizer vaccines dahil iyan ang napatunayan nang pinakamabisa laban sa coronavirus,” she added.
If FDA Philippines is still unable to issue either a provisional or full certificate of product registration for the Moderna and Pfizer primary series and boosters, Co suggested that a new executive order on the state of public health emergency could be issued as an alternative to extending the state of calamity. This would ensure that EUA for the COVID vaccines would continue.
“Ngunit nagtataka ako kung bakit hanggang ngayon ay hindi pa inilalabas ng FDA Philippines ang certificate of product registration kasi sa USA August 23, 2021 pa nabigyan ng US FDA ng full approval ang Pfizer vaccine na Comirnaty. January 31, 2022 nang ilabas ng US FDA ang full approval nito para sa Moderna Spikevax vaccine,” Co said
“Ano pa ba ang hindi natatapos gawin sa approval process ng mga bakunang iyan? Matagal ko nang itinatanong ito pero hanggang ngayon, walang klarong sagot mula sa DOH o FDA.,” she added.
Tags: #FDA, #DOH,#IATF #booster shots