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How Soon Will Novavax File for Emergency Use Authorization for Its COVID Vaccine?

By Keith Speights and Brian Orelli, PhD - Apr 15, 2021 at 6:09AM

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European filings will likely come sooner than the biotech's U.S. submission.

Novavax (NVAX 2.80%) wowed investors with its announcement in March of high efficacy for its COVID-19 vaccine candidate NVX-CoV2373. The next big step for the biotech is to file for Emergency Use Authorizations (EUAs) with regulatory agencies. In this Motley Fool Live video recorded on April 7, Motley Fool contributors Keith Speights and Brian Orelli discuss what the timeline might be for Novavax filing for EUAs for NVX-CoV2373.

Keith Speights: How soon do you think we're going to know something from Novavax's U.S. study, and how quickly could the biotech potentially file for Emergency Use Authorization in the U.S. for its COVID vaccine?

Brian Orelli: The U.S. data I think is expected this quarter, so we're looking at the end of June, and then maybe figure two months-ish to file and get the FDA to look it over and presumably they'll have an advisory committee meeting. Although I don't know if we really necessarily need one at this point.

The EU authorization, I think that it's going to come in earlier than that. They filed a rolling review in early February, so we're two months into that review already. Maybe it could come any day now, I'm not really sure.

The EU timelines are little less set in stone than the FDA's, there tends to be pauses in the clock depending on if the EU needs more information they come to the sponsor, the company and say, we need some more information and that pauses the clock. So now the EU regulators aren't on the clock, and so that time doesn't count for the time that they are allowed to be reviewing the drug.

Speights: Do you think Novavax might get emergency authorization in the U.K. even before EU?

Orelli: I'm not really sure with Brexit how the U.K. is doing it separately from the EU. I think the U.K. regulators seem to be a little more interested in doing it quickly. I think AstraZeneca might have gotten its U.K. authorization before they got the EU authorization. I think that's probably likely.

Speights: It certainly doesn't hurt that Novavax's study was conducted in the United Kingdom. That could help them get U.K. authorization more quickly.

Brian Orelli, PhD owns shares of Novavax. Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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