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Novavax's COVID Vaccine Trial: Are There Any Yellow Flags So Far?

By Keith Speights and Brian Orelli, PhD - Mar 3, 2021 at 6:15AM

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Only details about the diversity of participants have been released at this point.

Novavax (NVAX -3.78%) has completed enrollment in its late-stage study of COVID-19 vaccine NVX-CoV2373 that's being conducted in the U.S. and Mexico. The biotech recently released some details about the diversity of participants in the study. In this Motley Fool Live video recorded on Feb. 24, 2021, Fool.com contributors Keith Speights and Brian Orelli discuss whether or not there are any yellow flags with Novavax's COVID-19 vaccine trial so far.

Keith Speights: We have a question about Novavax's vaccine technology. I will probably mispronounce the viewer's name here. Gebran maybe. He says, "I feel that Novavax's vaccine technology makes it possible for them to cover more variants by tweaking the polypeptides/surface antigens."

Novavax, by the way, announced earlier this week that they've completed enrollment in their late-stage study of their COVID vaccine in the US and Mexico, they were enrolling 30,000 participants. There's this comment or question about Novavax's technology.

I think there was also some interesting data in the breakdown of their enrollment in this study. They mentioned they had only 13 percent were older adults ages 65 years and older and they gave breakdowns on some other information about the diversity of their participants.

What do you think in terms of this viewer's question and then any potential yellow flags with the diversity of Novavax's study?

Brian Orelli: I think in terms of who is going to be easiest to get a variant delivered, I think the mRNAs are actually probably easier to deliver a variant compared to Novavax. Only because changing the process of the mRNA production is really pretty simple, you just change the DNA that the RNA made out of which is trivial, and then you can produce the new variant mRNA.

Whether you want to do a batch of multiple different variants, I think you can still produce those separately and then mix them together and then have a single shot that results in production of the proteins for multiple variants that your body then creates an immune reaction to. Novavax could do it all on one molecule, which is true of the commenter's point.

But I think that adding those proteins, it's harder to work with proteins than it is to work with DNA or RNA in terms of changing the structure of the molecule. For that reason alone, I think the mRNAs might have a slight edge over Novavax.

In terms of the yellow flags on the diversity of the clinical trial. The only one that I really saw was that older adults one, which was 13 percent. I had commented earlier than I thought this was going to be the case, that people weren't going to want to go into a clinical trial when they knew that there was a possibility of getting the placebo when you know you have a 100 percent chance of eventually getting the Moderna and Pfizer vaccines.

To compare that: Pfizer's Phase 2, 3 clinical trial had 20.9 percent 65 or older, and Moderna, its pivotal trial had 25.3 percent 65 or older, so 20.9 and 25.3 versus Novavax's 13 percent. Whether that will trip up them up in the FDA, maybe it doesn't even matter because if they don't get approval for 65 and older, they are late to the game on 65 and older, so maybe it doesn't even matter.

Plus they're going to have some UK data from that clinical trial, which I haven't gone back and checked but I think probably has higher percentage of 65 and older because it was run mostly before the approvals in the UK. I think they will be fine, I don't think it's a major problem one way or the other.

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