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Is Novavax Delaying Its COVID Vaccine EUA Filings Yet Again?

By Keith Speights and Brian Orelli, PhD – Sep 26, 2021 at 7:04AM

Key Points

  • Novavax has delayed EUA filings for its COVID-19 vaccine several times.
  • The company's main challenge has been related to manufacturing.
  • While delays are frustrating to investors, Novavax could still achieve success with its vaccine.

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Regulatory submissions should be on the way... eventually.

Novavax (NVAX -1.96%) has found hitting target dates for regulatory filings is easier said than done. The company delayed its planned submissions for Emergency Use Authorization for COVID-19 vaccine NVX-CoV2373 earlier this year. In this Motley Fool Live video recorded on Sept. 15, Motley Fool contributors Keith Speights and Brian Orelli talk about whether Novavax could experience further delays and what it might mean for the stock.

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Keith Speights: Let's switch to a different COVID-19 story now. Novavax has delayed its timeline for filing for emergency use authorization of its COVID-19 vaccine several times already and the company has been saying that it would file for EUA in the United Kingdom in the third quarter and they said that that will be followed quickly by EUA submissions in the European Union and Australia, Canada, and New Zealand, with US EUA filings in the fourth quarter.

But over the last several days, the company's management team has been on the healthcare conference circuit speaking at several different conferences. It sounds like Novavax is waffling some on the timing of those filings. Do you think there will be yet another delay for Novavax here?

Brian Orelli: Every day we get closer to the end of September is a day less that we don't [laughs] have the ability to file in the third quarter. Then presumably, the issue is still with manufacturing. At this point, I'm not sure a month or two really matters all that much although I keep saying at every delay. At some point, the aggregate of all the delays has been substantial.

The company has basically at this point lost out on a major opportunity that was snatched up by Pfizer (PFE -0.33%) and BioNTech (BNTX 0.16%) and then Moderna (MRNA 0.48%). It will get the sales through the government contracts one way or the other, assuming there's no deadlines built into those contracts. I'm not aware of any that have been disclosed publicly.

There could be deadlines at some point or governments could come back and say, well, you're not living up to your end of the bargain and so we're canceling the contract. But hopefully, Novavax gets this done fairly quickly.

At this point, I think the company and its investors, and I'm a shareholder, so that includes me, are really just hoping for annual boosters like every other COVID-19 vaccine maker. But it's got to get it act together and get this manufacturing situation set up so that it can get the emergency use authorization so that it can collect that cash for giving the governments what they've ordered.

Speights: I'm going to predict, Brian, and this is an easy prediction. I'm going to predict Novavax's share price will remain highly volatile [laughs] for a while now but sooner or later, the company will get those EUA filings in, I'm sure.

I think the clinical data is there and like you said, it's probably manufacturing issues that's the holdup and when it does, all that volatility will be forgotten and the stock will take off again. That's my prediction.

Orelli: Yeah. It's not going to get to Moderna even probably BioNTech's level of valuation just because they've missed that boat and they're not going to have nearly as high, they're going to hit 20 billion in sales this year and next year like Moderna is. Shareholders shouldn't expect that high of valuation, but I feel like there's definitely potential for it to go higher than that maybe 17 billion market cap right now.

Keith Speights owns shares of Pfizer. The Motley Fool recommends Moderna Inc. The Motley Fool has a disclosure policy.

Stocks Mentioned

Novavax Stock Quote
Novavax
NVAX
$16.52 (-1.96%) $0.33
Pfizer Stock Quote
Pfizer
PFE
$50.91 (-0.33%) $0.17
Moderna Stock Quote
Moderna
MRNA
$182.35 (0.48%) $0.87
BioNTech Se Stock Quote
BioNTech Se
BNTX
$169.74 (0.16%) $0.27

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