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AstraZeneca's Vaccine Data Is Still Good Enough for U.S. Authorization

By Brian Orelli, PhD and Keith Speights - Apr 17, 2021 at 9:13AM

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An Emergency Use Authorization from the FDA should happen soon.

AstraZeneca (AZN -0.67%) created some drama releasing interim COVID-19 vaccine results just days before the pharma was able to generate final results from the U.S.-based phase 3 study. In this video from Motley Fool Live, recorded on March 29, Fool.com contributors Brian Orelli and Keith Speights discuss the brouhaha, and what it means for AstraZeneca's long-term prospects.

Brian Orelli: AstraZeneca reported a final data from its COVID-19 vaccine -- that it went from 79% efficacy at preventing symptomatic COVID-19 for the interim look and then at the final look it was 76%. Are three percentage points really that big of a deal?

Keith Speights: No, not really. Actually, it's certainly not a big enough difference between the initial results that AstraZeneca reported and these latest results to warrant or justify all of the controversy and stir. There was a big controversy over whether or not AstraZeneca should have reported that initial results, and they're people taking both sides on the issue, but the difference was very minor when all was said and done. AstraZeneca's press release stated that the latest results were consistent with their earlier results. I guess that depends on how you define consistent, but certainly the numbers were pretty close when all was said and done.

Actually, interestingly to me, AstraZeneca might have been a little better waiting to announce the results until they had some of the additional data because their initial report was that they had 80% efficacy against symptomatic COVID in adults aged 65 and up, but in the latest data, that efficacy actually rose to 85%. At least one of the numbers was markedly better than what they originally reported.

Probably the most important thing for investors to focus on here, that both of these announcements show data that AstraZeneca's vaccine achieved 100% efficacy against severe or critical disease and hospitalization and that's the important thing, I mean, that it's preventing the severe cases of COVID and I think that pretty much guarantees AstraZeneca is going to win emergency use authorization, at least that's my prediction.

Orelli: Of course, the severe and critical disease and hospitalizations, there was like eight maybe in the placebo group. We don't really know if it's really 100% because eight versus zero and eight versus one, is no.

Speights: Yeah and really all of these percentages should be taken with a little bit of a grain of salt. Because in real world, we'll see what it ends up being. But they're approximations.

Orelli: Yeah. Do you think that AstraZeneca should have just waited for the final data and not presented the interim results even though they calculated them?

Speights: Yeah, like I said, I've seen arguments on both sides of this. Look, AstraZeneca had a preset date, that they were going to analyze the data and they used that date and all the data that came in. Where the controversy came in was the company already knew some other results that were after that date and they didn't hint at all that they would have more updated data on the way. I'm on the fence on this Brian, at one point I was like AstraZeneca just made a mistake. They made it a PR mistake. But I understand the argument on the other side. So I'm on the fence.

Orelli: Yeah. I think that I have no problem with them presenting interim data. I just think all they needed was a line in that press release that said, ''We've hit the number of events for the final readout and we'll get them to you as soon as we can.'' If they had just done that, I don't think anyone would have a problem with the numbers change. Novavax (NVAX 12.49%) did the same thing. There was a lot longer distance between when they presented preliminary data and when they presented final data, and the numbers changed as they are apt to do. But I don't think it was really that, no one complained about it. It wasn't a big deal. Just because the longer time, and AstraZeneca already had that data, that they still needed to do some math on it and statistics on it. But they had the data and they knew roughly what it was going to maybe.

Speights: Right. I totally agree with you and I think that part of the issue here was that they did have the data in hand and it didn't take them very long at all to get that information out. It was what? Within 48 hours or so. I think it ended up being a lot of controversy about essentially nothing because the results were so close to the initial results that they reported.

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