FDA expects to decide on Pfizer’s emergency use application on Jan. 14

MANILA, Philippines — The Food and Drug Administration (FDA) is eyeing to issue a decision on the emergency use application (EUA) application of Pfizer-BioNTech’s COVID-19 vaccine by January 14, its chief Director General Eric Domingo said Wednesday.

In a televised briefing, Domingo presented the timeline of Pfizer’s EUA application which indicated January 14 as the date when FDA’s decision will come out.

“Kahapon po, nagbigay ng konting mga katanungan yung ating mga eksperto na pinadala natin sa Pfizer at binigyan ko sila ng 48 hours to reply and to give us the information requested by our panel,” Domingo said.

(Yesterday, our experts gave some questions to Pfizer and I gave them 48 hours to reply and give the information requested by our panel.)

Screenshot from PTV4

“Pagkatapos po noon, ibabalik nila sa akin ‘yan ng January 10 at days after that, makakagawa na po tayo ng desisyon sa kanilang EUA application,” he added.

(After that, they will return that to me by January 10 and days after that, we can finally make a decision on their EUA application.)

Only Pfizer has so far submitted an EUA application for its COVID-19 vaccine in the Philippines.

Recently, Pfizer was granted an emergency validation by the World Health Organization (WHO).

WHO explained emergency use listing opens the way for regulators in different countries to approve the import and distribution of the vaccine.

JPV