MANILA – Itinuturing na magandang balita ng Department of Health (DOH) ang paggawad ng emergency use validation ng World Health Organization (WHO) ang COVID-19 vaccine na dinevelop ng mga kompanyang Pfizer at BioNTech.
“That’s a welcome development,” ani Health Sec. Francisco Duque III.
Ayon sa kalihim, mas mapapadali ng emergency use grant ng WHO, ang aplikasyon ng mga kompanya para sa hiwalay na emergency use authorization sa Pilipinas.
Isa kasi ang naturang dokumento sa mga ikinokonsidera ng Food and Drug Administration (FDA) para mabigyan ng EUA ang isang vaccine developer.
“That’s a given the process can be abbreviated because there is an approval by a regulatory authority coming from the US, the one’s coming from WHO is a welcome addition to the reg approvals and therefore that should be a lot easier for the local FDA to already review all the docus and assess the risk benefit ratio of the said candidate vaccine,” dagdag ni Duque.
Patuloy pang ine-evaluate ng FDA ang aplikasyon ng Pfizer-BioNTech. Agad naman daw silang maglalabas ng desisyon kapag na-kumpleto na ang lahat ng requirements at proseso.
“Our experts are currently evaluating documents submitted by Pfizer as outlined in our guidelines. I’ll issue a decision on the application as soon as all regulatory requirements & procedures are completed,” ani FDA director general Eric Domingo.
Bago matapos ang 2020, ginawaran ng emergency use validation ng WHO ang COVID-19 vaccine na bunga ng partnership ng US at Germany-based companies.
Sila ang pinaka-unang kompanya na nakatanggap ng naturang approval mula sa WHO, sa gitna ng karera ng iba’t-ibang developers ng bakuna laban sa coronavirus disease.
EMERGENCY USE LISTING
Ayon sa WHO, matapos mabigyan ng emergency use validation ang bakuna, dadaan naman ito sa proseso ng emergency use listing (EUL).
Sa nasabing proseso sinusuri ng mga eksperto ng WHO at regulatory authorities ng iba’t-ibang bansa kung suitable o angkop ang mga bagong gawang health products sa gitna ng public health emergency, tulad ng COVID-19 pandemic.
Layunin ng EUL na mapabilis ang distribusyon ng mga gamot at bakuna na ligtas at epektibo panlaban sa kumakalat na sakit, gayundin kung ang pagkakagawa rito ay may kalidad.
“The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.”
“The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan.”
Bahagi din daw ng EUL process ang pagtitiyak na patuloy na mangangalap ng datos ang kompanya hanggang mabigyan ng lisensya at WHO prequalification.
Binigyang diin ng WHO ang kahalagahan ng patas na distribusyon para matiyak na lahat ng populasyon ay matuturukan ng bakuna laban sa COVID-19.
“This is a very positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” pahayag ni Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
