FDA expects new applications for EUA this week

Published April 11, 2021, 7:47 PM

by Leslie Ann Aquino

American drugmaker Moderna is expected to file for emergency use authorization (EUA) this week.

“We heard that Moderna may apply this week. They are just collating their documents,” FDA Director-General Eric Domingo said in a radio interview Sunday, April 11.

FDA Director General Eric Domingo (MANILA BULLETIN FILE PHOTO)

Last month, the FDA granted an EUA to the Sputnik V vaccine of Russia’s Gamaleya Research Institute. 

Gamaleya became the fourth drugmaker to be granted an EUA for their COVID-19 vaccine after Pfizer-BioNTech, AstraZeneca, and Sinovac.

Those with pending applications are Bharat Biotech and Janssen Pharmaceuticals. 

The FDA official, meantime, is not ruling out the possibility of the Department of Health (DOH) applying an EUA on behalf of Sinopharm.

“The government, the DOH, may apply being an implementer of the vaccination program,” said Domingo.

“But even if it is the DOH applying, they still have to submit proof and documents showing the safety, efficacy, and quality of the product,” he added.

 
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