FDA expects Moderna to apply for EUA of COVID-19 vaccine next week

Published April 16, 2021, 1:59 PM

by Jhon Aldrin Casinas

American pharmaceutical firm Moderna is expected to apply next week for an emergency use of its vaccine against the coronavirus disease (COVID-19) in the country.

This file photo taken on November 18, 2020 shows a syringe and a bottle reading “Vaccine Covid-19” next to the Moderna biotech company logo.

Food and Drug Administration (FDA) Director General Eric Domingo said Moderna was supposed to file its emergency use authorization (EUA) application for its COVID-19 vaccine this week.

But as of Friday, April 16, the food and drug regulatory body has yet to receive their application.

“Sabi nila nung una this week. Nung huli namin silang nakausap this week. Pero until now they have not yet filed an application (They said earlier that they will file this week. The last time we talked to them, they said this week. But until now they have not yet filed an application),” Domingo told reporters.

“Hopefully by next week, mag-apply na rin siguro sila (Hopefully by next week, maybe they will apply),” he added.

The FDA chief said the agency expects that they would not have too much difficulty in evaluating the application because Moderna already has an EUA from other regulatory authorities.

“Pag ganito kasi talagang mas nababasa natin lahat nung mga evaluation reports ng mga nauna sa atin, at mas mabilis nating nagagawan ng desisyon (In this case, we can really read all the evaluation reports of those before us, and we can make decisions faster),” Domingo said.

Currently, the FDA is evaluating the EUA applications of India’s Bharat Biotech and Belgium-based Janssen Pharmaceuticals for their COVID-19 vaccines.

So far, the FDA granted EUA to four vaccine developers namely: US-drugmaker Pfizer, British firm AstraZeneca, Russia’s Gamaleya Research Institute, and China’s Sinovac Biotech.