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Why Are Participants in Novavax's COVID Vaccine Study Receiving 2 Extra Shots?

By Keith Speights and Brian Orelli, PhD - Apr 14, 2021 at 6:31AM

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There's a simple -- and good -- reason.

Like most of the other COVID-19 vaccines that have already won Emergency Use Authorization (EUA), Novavax's (NVAX 2.68%) vaccine requires two shots spread several weeks apart. But the biotech recently announced that participants in its late-stage clinical studies will have the option to receive two additional shots. In this Motley Fool Live video recorded on April 7, Motley Fool contributors Keith Speights and Brian Orelli talk about why Novavax is making this move.

Keith Speights: Novavax, the ticker there is NVAX, recently announced that it has initiated crossover arms with its late-stage studies that are going on in the United Kingdom, and in the U.S. and Mexico. Again, these are late-stage studies of its COVID-19 vaccine. Participants in these studies will be given the choice of receiving two extra shots in addition to the two shots they already received. Brian, what's the rationale behind this move?

Brian Orelli: It's a two-for-one deal. Novavax gets twice as much data for the same number of participants.

Of course, the cost isn't the same. They're only really saving money on the recruiting costs. The people participating presumably are getting twice as much money, and then they're having to pay the doctors twice as much. But they are getting more data, so they're crossing over patients in the placebo group, they're now going to get the vaccine, and people in the vaccine group are now going to get the placebo.

I was a little surprised that they were going to do the vaccine to the placebo crossover. I figured it would be a one-way open-label study where everybody who originally got the placebo will be told, "You got the placebo, and so now we're going to give you the vaccine."

But this should theoretically give them more data by also not telling the people who got the vaccine that they got the vaccine and then giving them the placebo. I'm curious how the company is handling the people who don't want to continue the study. Are they going to disclose to them which group they were in? Did they get the vaccine, or did they get the placebo.

Speights: This is a way, right, Brian, for Novavax to keep people in the study yet still be assured that they're going to get vaccinated?

Orelli: Yeah. Typically in almost every clinical trial, if you're in the placebo group, you're offered the drug, whatever it is, vaccine or whatever, after the end of the study. The chances you're going to get the placebo is because you know you'll eventually going to get this drug, and assuming it works, they'll give it to everybody.

Novavax gets extra data by then now studying in all the people who didn't get the placebo. They got a placebo originally, now they'll get more data on them getting the vaccine. Mostly I think they're looking at side effects here because, so now everybody in the clinical trial will have been vaccinated, they won't have a comparator to look at the actual rate of COVID-19 infections.

Speights: Now this will not impact Novavax's schedule or timeline for filing for Emergency Use Authorization.

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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