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Astrazenica admits she made a mistake, is her vaccine safe?
After celebrating the results of its experiment a few days ago, it has now been revealed that the dose that yielded the most effective results for Astrazenica is the result of a mistake during the experiment, and the company is facing difficult safety questions
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Thursday, November 26, 2020, 12:15 p.m.
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In the video: AstraZenica and Oxford's corona vaccine is up to 90% effective (Photo: Reuters)
Was the joy too early?
The Astraznica company, which earlier this week released the results of the second phase of its experiment in which it showed an efficiency of up to 90 percent, now admits that a mistake was made in the experimental stages, the New York Times reports.
Now, just before she seeks emergency clearance for the use of the vaccine she has developed, she is faced with difficult questions regarding the safety and efficacy of the vaccine she has developed in collaboration with the University of Oxford in the UK.
Since the disclosure of the initial results, Astraznica has recognized a major error in the vaccine dose received by some study participants.
The New York Times reports that the results showed that exactly half of the vaccine given to the vaccinated, which was found to be more effective than the original full dose, originated in an error that should not have occurred in the original protocol.
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To the full article
According to the published results, 131 of the trial participants who received the experimental vaccine became infected with corona during the trial period, but none of them severely contracted covid-19 or needed hospitalization.
Maximum efficacy of the vaccine was obtained when half a dose was given, then a full dose at least a month apart.
If two full doses were given one month apart, the effectiveness of the vaccine was only 62 percent.
The average efficiency of the experiment reached 70 percent.
Difficult questions regarding the safety and effectiveness of the vaccine.
A test tube with a corona vaccine from the Astraznica company (Photo: Reuters)
U.S. officials said your results in this trial were unclear, and it was the federal authorities that believed the issue - rather than Astrazhenica itself - first discovered that the most promising results of the vaccine did not reflect full data, and participants who received the initial dose were 55 and under.
The result, according to experts, is that the chances of the vaccine being approved in an emergency format are diminished, which is an unexpected setback in the global campaign to stop the devastating epidemic.
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The current storm is not the first obstacle Astraznica faces on its way to approving its experimental vaccine.
Last September, the company stopped its trial after one of the experimenters contracted an inflammation in the nervous system, and it was unclear whether this happened as a result of the vaccine he received or not.
Corrected the mistake and continued the study.
Participates in AstraZenica trial gets vaccinated (Photo: Reuters)
In an interview on Wednesday, Sir Menalas Pangalos, director of Astraznica, who is responsible for much of the company's research and development, defended the company's handling of its tests and disclosure.
He said the dosing error was made by a third party hired by the company for the benefit of the experiment, and when it was discovered, the company was prepared to continue testing the vaccine in various doses.
The company revealed in its initial announcement that less than 2,800 participants received the smaller dose, compared to nearly 8,900 participants who received two full doses.
A useful mistake?
The biggest questions now are why there has been such a big difference in the effectiveness of the vaccine in different doses and why does it seem that a smaller dose actually yields much better results?
Researchers, unfortunately, say they do not know.
"The press release raised more questions than answers," experts said.
"The reality is that this may turn out to be a pretty useful mistake," Panglos said in an interview with the New York Times yesterday.
"It did not put anyone in danger, it was a dosing error. Everyone progressed very quickly. We corrected the mistake and continued the study, without changes, and with the consent of the regulator it was decided to include the same patients in the study analysis."
He added, "What has to be revealed? The fact is that it does not matter whether it is done intentionally or not."
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