FDA sumagot kung 'nangungulelat' ba ang Pilipinas sa bakunahan vs COVID-19 | ABS-CBN

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FDA sumagot kung 'nangungulelat' ba ang Pilipinas sa bakunahan vs COVID-19

FDA sumagot kung 'nangungulelat' ba ang Pilipinas sa bakunahan vs COVID-19

Karen Davila,

ABS-CBN News

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MAYNILA — Kung gumugulong na ang pagbabakuna kontra COVID-19 sa ibang bansa, sa Pilipinas ay umamin mismo ang Food and Drug Administration (FDA) na wala ni isa pang vaccine firm ang nag-apply para sa emergency use authorization (EUA).

Sabi ni FDA Director General Eric Domingo, inuuna ng gobyerno ang pagbili ng mga bakuna sa China dahil sa agawan sa suplay, kahit wala pa itong FDA approval.

"Wala pa, we are still waiting for applications... Most governments are doing early negotiations. But, officially, it will never be used until they get an EUA from FDA and only after submitting all the documents needed convincing us of the safety and efficacy of the vaccine," anang opisyal.

Sa isang tweet, inanunsyo ng Chinese embassy na tinatapos na lang ang kasunduan para makapag-supply ang Sinovac ng 25 million doses ng bakuna sa Marso 2021.

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Pero 'di ibig sabihin ay basta-basta lang itong puwedeng gamitin.

"If they make preorders or prepayments, that's not part of the criteria we will be using at the FDA to judge whether to give an EUA or not," ayon sa FDA.

Kaya’t kung target ang rollout ng bakuna sa Marso 2021, dapat ay mag-apply na ngayon ng EUA ang Sinovac o ang gobyerno para rito.

"These vaccines only have EUAs in China but not in what we call the mature regulatory agencies or the WHO-qualified regulatory agencies... So we’re going to take a look at these and it will take a little longer than a product that has already been approved by the US or Japan or Singapore," ani Domingo.

Wala ring clinical trials na ginagawa sa ngayon sa Pilipinas. Kaya ang tanong ng ilan, hindi ba nangungulelat ang Pilipinas pagdating sa immunization program?

"Hindi naman. There's something good about it because when they do get an EUA here... they can submit their experience... So the early adverse events of allergies na nakita sa UK, now we know what we have to watch out for this," depensa ni Domingo.

Ngayong Disyembre gustong isara ng gobyerno ang kontrata sa China lalo't target nitong magbakuna ng 3 milyong Pilipino sa Marso.

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