ni Lolet Abania | November 18, 2021
Maaari nang maibenta sa mga botika ang maraming COVID-19 vaccines sa unang quarter ng 2022 kapag nabigyan na ito ng full approval ng Food and Drug Administration (FDA).
“My prediction is early next year, by the first quarter, not only Pfizer maybe several of the existing vaccines will get full approval for marketing authorization,” pahayag ni FDA Director General Eric Domingo sa isang interview ngayong Huwebes.
Ayon sa Johns Hopkins Medicine, “full approval is granted when the FDA has amassed enough scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality.”
Sa ngayon, binigyan na ng FDA ng emergency use authorization (EUA) ang siyam na vaccine brands, gaya ng Pfizer-BioNTech (Comirnaty), AstraZeneca, Sinovac (CoronaVac), Gamaleya Institute (Sputnik V), Johnson & Johnson (Janssen), Bharat Biotech (Covaxin), Moderna, Sinopharm, at Novavax (Covovax).
Sa ilalim ng EUA, ang gobyerno lamang ang maaaring mag-procure ng vaccines habang ang mga pribadong kumpanya ay puwedeng bumili sa pamamagitan ng isang tripartite agreement.
Ayon kay Domingo, una nang pinagkalooban ng United States ang Pfizer ng full authorization noong Agosto. Gayunman, hindi pa nag-a-apply ang Pfizer para naman sa full approval ng Pilipinas.
“We did ask them and they said they were completing their documents and requirements... It’s not going to take long but they haven’t applied yet. It’s probably because the company is not yet ready to supply, baka nagko-concentrate sila sa one market at this time,” sabi ni Domingo.
Sinabi pa ni Domingo, binigyan na rin ng FDA ng EUA ang investigational drug na ronapreve para sa COVID-19 treatment, habang isa pang medisina, ang molnupiravir ay maaari namang makuha sa mga ospital na may compassionate use permit.
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