FDA starts evaluating EUA application of Novavax’s COVID-19 vaccine

Published August 9, 2021, 4:31 PM

by Jhon Aldrin Casinas

The Food and Drug Administration (FDA) has started evaluating the application of American biotechnology firm Novavax for an emergency use authorization (EUA) of its coronavirus vaccine.

(AFP / FILE PHOTO / MANILA BULLETIN)

FDA Director-General Eric Domingo said the agency has now begun its evaluation after the company has submitted most of the listed requirements for the EUA application.

“Inumpisahan na natin ang evaluation niyan (We have started the evaluation for that), both for the manufacturing side, and for the safety and efficacy side,” Domingo said in a public briefing Monday, Aug. 9.

But he pointed out that the US-based pharmaceutical firm has yet to complete the submission of its requirements in order for the agency to make its decision.

Domingo explained that it takes 21 days for the FDA to complete its evaluation as along as an EUA applicant submits their complete requirement.

The FDA chief noted that the Novavax vaccine has an efficacy rate that is “very similar” to existing vaccines in the country, between the range of 80 to 90 percent.

Once approved, the Novavax vaccine against coronavirus disease (COVID-19) would be the eighth vaccine allowed for use in the Philippines.

The FDA already granted EUA for the COVID-19 vaccines made by Pfizer-BioNTech, AstraZeneca, Sinovac Biotech, Gamaleya Research Institute, Johnson & Johnson, Bharat Biotech, and Moderna.

 
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