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LiberalArkie

(15,686 posts)
Wed Nov 25, 2020, 11:53 AM Nov 2020

The AstraZeneca Covid Vaccine Data Isn't Up to Snuff

11.25.2020 08:00 AM

THE MAKERS OF a third coronavirus vaccine announced positive results in clinical trials on Monday, setting off yet another round of excited news reports. This one, produced by a partnership between a University of Oxford research institute, its spinout company Vaccitech, and the pharmaceutical company AstraZeneca, does not need to be stored at freezing temperatures and would be cheaper and easier to produce than the high-efficacy vaccines produced by BioNTech-Pfizer and Moderna. Indeed, according to an initial write-up in The New York Times, Oxford-AstraZeneca’s is “expected to be relied upon heavily across the globe, to help curb a pandemic that has killed more than 1.3 million people.”

Sounds like great news, right? Monday’s press release from AstraZeneca presents “convincing evidence that [the vaccine] works,” said Science. But not everyone has been convinced. The price of AstraZeneca’s shares actually dropped on the news, and an analysis from an investment bank concluded, “We believe that this product will never be licensed in the US.” Over at STAT News, Anthony Fauci cautioned that we’ll need to see more data before coming to a conclusion. The skeptics have strong reasons to be concerned: This week’s “promising” results are nothing like the others that we’ve been hearing about in November—and the claims that have been drawn from them are based on very shaky science.

The problems start with the fact that Monday’s announcement did not present results from a single, large-scale, Phase 3 clinical trial, as was the case for earlier bulletins about the BNT-Pfizer and Moderna vaccines. Instead, Oxford-AstraZeneca’s data came out of two separate studies: one in the UK that began in May, and another in Brazil, which got started at the end of June. These two studies were substantially different from one another: They didn’t have standardized dosing schemes across the trials, for one thing, nor did they provide the same “control” injections to volunteers who were not getting the experimental Covid vaccine. The fact that they may have had to combine data from two trials in order to get a strong enough result raises the first red flag.

Consider that leading vaccine makers—including AstraZeneca—issued a scientific-rigor-and-integrity pledge back in September, in which they promised to submit their products for approval or emergency use authorization only “after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.” Note the wording here: These companies did not suggest that they might claim to have demonstrated efficacy through multiple, distinct clinical studies, combined together to get enough data. They said they would use a Phase 3 study—as in, one big one. Yet AstraZeneca has already applied on the basis of this data for approval in Canada, and has plans to do the same in Britain, Europe and Brazil. The company also says it will use the data to apply for emergency use authorization in the US.

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https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/

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The AstraZeneca Covid Vaccine Data Isn't Up to Snuff (Original Post) LiberalArkie Nov 2020 OP
Good to know soothsayer Nov 2020 #1
I really believe this is a ploy to get their stock to increase so the stock holders can make money. redstatebluegirl Nov 2020 #2
This message was self-deleted by its author redstatebluegirl Nov 2020 #3

Response to LiberalArkie (Original post)

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