Please ensure Javascript is enabled for purposes of website accessibility

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

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

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.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Novavax, Inc. Stock Quote
Novavax, Inc.
$41.47 (2.80%) $1.13
AstraZeneca PLC Stock Quote
AstraZeneca PLC
$66.64 (3.08%) $1.99

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 08/15/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.