FDA: Novavax already signified intention to apply for EUA

Published June 14, 2021, 11:15 PM

by Leslie Ann Aquino

Food and Drug Administration (FDA) Director General Eric Domingo said Novavax has already signified its intention to apply for emergency use authorization.

FDA

“Novavax already wrote the other day signifying their intention to apply for emergency use authorization. In fact, they already sent some of the clinical trial results to us,” he said in a meeting with President Duterte Monday, June 14.

Domingo said it is now being studied by experts although it has yet to officialy apply.

He said Novavax may apply by July or August.

Last week, Domingo said the FDA has approved for emergency use the COVID-19 vaccine Sinopharm.

In the past, FDA also granted an EUA to the Sputnik V vaccine of Russia’s Gamaleya Research Institute for their COVID-19 vaccine, Pfizer-BioNTech, AstraZeneca, and Sinovac to mention a few.

Meanwhile, the Department of Health (DOH) said COVID-19 vaccines must secure Certificates of Product Registration (CPR) from the FDA before they are allowed to be made available commercially.

“Vacccine manufacturers may submit an application for CPR once they have finished all the clinical trial phases,” she said in a virtual forum.

“Once they have a CPR already, it can already be made available commercially,” added Vergeire.

 
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