FDA: ‘MODERNA NAGSUMITE NA NG APLIKASYON PARA SA EUA NG COVID-19 VACCINE NITO SA PINAS’

Ni Raiza F. Cabugwang
Photo courtesy of pna.gov.ph; Anadolu
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Ayon sa Food and Drug Administration (FDA), nagsumite na ang US-based drugmaker na Moderna ng aplikasyon para sa emergency use authorization (EUA) ng bakuna nito laban sa Coronavirus disease 2019 (COVID-19) dito sa Pilipinas.

Sinabi ni FDA Director General Eric Domingo na naghain ang naturang kumpanya ng kanilang aplikasyon para sa EUA ng kanilang bakuna nito lamang Lunes, Abril 26, 2021.

Ayon sa pinakahuling datos mula sa Department of Health, kinakailangang maturukan ang isang indibidwal ng dalawang doses ng naturang bakuna sa pagitan ng 28 araw.

Dagdag pa rito, kinakailangang nakalagay ang Moderna vaccine sa imbakang nasa -25 hanggang -15 degrees Celsius ang temperatura, o 2-8 degrees Celsius kung ito ay iiimbak sa loob ng 30 araw.

Base naman sa datos mula sa Phase 3 clinical trial ng Moderna vaccine, nasa 94.1 porsyento ang bisa nito sa symptomatic COVID-19 patients, samantalang 100 porsyentong epektibo naman ito laban sa severe o malalang uri ng COVID-19.

Sinabi ni Director General Domingo na hindi gaanong mahihirapan ang FDA sa pagsusuri ng aplikasyon ng naturang kumpanya para sa EUA ng COVID-19 vaccine nito sa bansa sapagkat nakakuha na ang Moderna ng EUA mula sa iba pang awtorisadong grupong nauna nang sumuri nito.

“‘Pag ganito kasi talagang mas nababasa natin lahat no’ng mga evaluation reports ng mga nauna sa atin, at mas mabilis nating nagagawan ng desisyon,” pahayag ng opisyal.

Samantala, nauna nang nabigyan ng EUA mula sa FDA ang COVID-19 vaccines na binuo ng US-drugmaker na Pfizer, British firm na AstraZeneca, Gamaleya Research Institute ng Russia, at Sinovac Biotech ng China.

Noon lamang Abril 19 ay pinahintulutan na rin ng FDA ang emergency use ng COVID-19 vaccine na binuo ng Bharat Biotech mula sa bansang India at Janssen Pharmaceuticals na naka-base naman sa Belgium.

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