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How AstraZeneca Flubbed Its Better-Than-Expected COVID Vaccine Update

By Keith Speights and Brian Orelli, PhD - Mar 31, 2021 at 6:09AM

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A U.S. government agency called out the drugmaker after it announced solid interim efficacy results.

AstraZeneca's (AZN 1.05%) release of efficacy results for its COVID-19 vaccine turned into something of a soap opera. The company received a rare criticism from the National Institutes of Health (NIH) after first announcing its interim results. In this Motley Fool Live video recorded on March 24, 2021, Motley Fool contributors Keith Speights and Brian Orelli talk about how AstraZeneca flubbed its better-than-expected COVID vaccine update. (Note: AstraZeneca subsequently released updated efficacy results on March 25 after this video was recorded.) 

Keith Speights: AstraZeneca, the ticker there is AZN. AstraZeneca announced better-than-expected results from a late-stage US study of its COVID-19 vaccine. They announced these results earlier this week. The company reported an efficacy of 79%. That's higher than Johnson & Johnson's efficacy of 72% for a single-dose vaccine. Still, quite below the mid-90s and up efficacies for both Pfizer and Moderna, but still, it's better than expected.

But then there was a plot twist. After AstraZeneca announced these results, which everyone thought were very good, the National Institutes of Health issued a statement that said that the company may have, but I think they pretty much insinuated that it did, included outdated information from the trial and it may have provided an incomplete view of the efficacy data. In other words, making the efficacy look better than it actually was. So Brian, what do you make of all of this?

Brian Orelli: The drama around this is vaccine seems to be never-ending. If you recall, first, it was the half dose seemed to be working better than the full doses, and the half doses were not even supposed to be there, they just were a mistake, and then there were issues with combining results from multiple clinical trials, some of which had different placebos. Sometimes it was an active vaccine and sometimes it's a natural placebo, so that complicates things.

The issue appears to be that AstraZeneca reported interim data based on a cutoff date of February 17. That in and of itself isn't weird that in terms of what was built into the clinical trial design. Moderna and Pfizer did the same thing -- they had multiple interim looks.

The issue that the independent data monitoring committee -- they notified the NIH, and then NIH notified the public -- is that AstraZeneca seems to have the final data. It makes sense. The cutoff date was February 17, but over the last month, people in the clinical trial have continued to develop COVID-19. So it appears that they have enough COVID-19 events for the final readout of the study, and so AstraZeneca says they'll release the final data within 48 hours of Tuesday's announcement, saying that they actually do have the final data and they'll get it out as soon as possible.

Speights: Brian, you've covered the healthcare space for years, as I have, but do you recall any situation like this one occurring in the past?

Orelli: No. I don't really know. I guess what they should have done is just waited for the final data and taken two extra days before they released it. Maybe the lawyers forced them to put it out because they have the information and it's material, so they are not allowed to just hold on to it for too long. So maybe that's the issue.

But I don't see why in the press release, they couldn't say, "We've also accrued enough data points to have the final readout and we're doing that as quickly as possible, and we'll have it out this week." I think if they had just done that in the press release, that would have been enough that none of this controversy would have occurred. Everybody would have been like, OK, we don't really know why they're releasing interim data, but we're going to get final data in a couple of days, so they can't be trying to fudge anything.

Speights: Right. But I guess the real thing here to note is this isn't the first time AstraZeneca has come under fire for how they presented data. When they presented their initial results last year, they blended data from two different dosing regimens, and that blended data made their efficacy look better than it otherwise would have, and they took some flak for that as well.

Orelli: Yeah. It's weird. I almost think it's the PR people maybe more than the scientists. But who knows? I agree, it's totally weird.

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Stocks Mentioned

AstraZeneca PLC Stock Quote
AstraZeneca PLC
AZN
$65.22 (1.05%) $0.68
Johnson & Johnson Stock Quote
Johnson & Johnson
JNJ
$174.77 (0.48%) $0.83
Pfizer Inc. Stock Quote
Pfizer Inc.
PFE
$51.49 (1.65%) $0.84
Moderna, Inc. Stock Quote
Moderna, Inc.
MRNA
$131.75 (-8.11%) $-11.63

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