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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsThe 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-AstraZenecas 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? Mondays press release from AstraZeneca presents convincing evidence that [the vaccine] works, said Science. But not everyone has been convinced. The price of AstraZenecas 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 well need to see more data before coming to a conclusion. The skeptics have strong reasons to be concerned: This weeks promising results are nothing like the others that weve been hearing about in Novemberand the claims that have been drawn from them are based on very shaky science.
The problems start with the fact that Mondays 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-AstraZenecas 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 didnt 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 makersincluding AstraZenecaissued 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 studyas 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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