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Could Novavax Win U.S. Authorization for Its COVID Vaccine by May?

By Keith Speights and Brian Orelli, PhD - Mar 12, 2021 at 7:03AM

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It's possible. Whether it's probable, though, is a different story.

Three COVID-19 vaccines are already on the market in the U.S. Another could be on the way. Novavax (NVAX 17.46%) CEO Stanley Erck thinks his company's vaccine just might win U.S. emergency use authorization as early as May. In this Motley Fool Live video recorded on March 3, 2021, Fool.com contributors Keith Speights and Brian Orelli discuss whether this timeline is realistic.

Keith Speights: Novavax reported their earnings results. We're not going to talk about the details of the earnings, but their CEO Stanley Erck said something interesting in their Q4 conference call. He said that Novavax's COVID-19 vaccine could when FDA emergency use authorization by May. How likely do you think that could be?

Brian Orelli: I think it depends. We don't know how long. They have a much better idea as the number of COVID-19 cases in the clinical trial are coming in, they have a good idea of when they are going to hit their endpoints. That's going to be the case. It may seem reasonable if they're going to use the US clinical trial data.

As investors, we don't know when that data is going to come in. The company, they know the number of cases that are coming in, they don't know whether they're in the placebo group or the vaccine group, but they know that once they hit a certain number, then they can go and underline the data and see how many were in the placebo group and how many were in the vaccine group. That's really the case.

I don't think they're going to get FDA approval based on the UK data on which I think that Stanley Erck had been talking about trying to get earlier. I think that's probably a low chance of just because they'd be the fourth potential emergency use authorization, and then plus supply is ramping up for the first three. I think [inaudible] US data and whether when that data comes the company has a lot more information about that the average investor does.

Speights: Generally speaking, Brian, do you think the FDA might become more lenient at allowing companies to file based on data from international studies that weren't conducted in the US?

Orelli: I feel like it would be less likely, especially in Novavax's cases. Because I think Novavax had to wait. The reason why they're behind is because we had to wait for manufacturing, they wanted to set up the manufacturing so that it will be the same scale as they were going to launch the commercial product to run the Phase three clinical trial with that. I don't know what the supply that ran the UK study, that vaccine or how it was made relative to what they want to launch commercial level lab.

But the FDA always wants you to have clinical trial data based on the manufacturing that you're going to launch the commercial products with. If that wasn't the case from UK then I think that companies will have a lot of problems trying to use foreign data.

But in general, I think the FDA is OK with it, but I think that it's harder for the FDA to accept it based on the need. If there's less of a need for a drug then they're going to want to see more US patients where if there's more of the need than US-like patients are probably good enough.

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