FDA: Pfizer vaccine emergency use authorization to be out in 1-2 days

MANILA, Philippines — The country’s Food and Drug Administration (FDA) is already finalizing the emergency use authorization (EUA) for Pfizer-BioNTech’s COVID-19 vaccine, and it is expected to be issued in one to two days.

FDA Director General Eric Domingo on Monday said Pfizer has applied for an EUA in December, and the country’s experts have already presented their inputs on its COVID-19 vaccine.

“Nakuha na namin lahat ng inputs ng experts namin, we are actually finalizing the EUA for Pfizer. It will be out in one or two days,” he said in a Senate inquiry on the government’s COVID-19 vaccination plan.

(We already have all the input of our experts. We are actually finalizing the EUA for Pfizer. It will be out in one or two days.)

The FDA is also already processing the EAU for the COVID-19 vaccine of British drug AztraZeneca, which has applied for an EUA this month.

Domingo said the EUA of AztraZeneca may be issued in mid-January.

“‘Yung AztraZeneca nag-apply na po sila after the New Year [for EUA] and we’re confident that we will be able to finish the process siguro by mid-January,” he said.

(AztraZeneca has also applied for an EUA after the New Year and we’re confident that we will be able to finish the process by mid-January.)

The EUA is seen to shorten the FDA’s process of approving COVID-19 vaccines from six months to just 21 days.

The FDA’s issuance of an EUA also means that the agency recognizes the vaccines’ approval by regulatory bodies overseas.

JE