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Volunteers from Mr.under 55 years, was referring to the dosing method that produced 90% efficiency rate for the University of Oxford vaccine and AstraZeneca against coronavirus, according to a post by Financial times.
This was not noted in the announcements earlier this week, raising questions about how the University of Oxford and AstraZeneca, have managed the early reading of their vaccine trials.
Researchers at the University of Oxford announced Monday that its average vaccine efficacy is 70%. In volunteers who received two full doses one month apart, the effectiveness was 62%, but in a smaller group of volunteers who initially received half the dose of the vaccine and then the entire dose, the corresponding rate increased to 90%.
The report also recalls that the administration of half the dose was caused by an error, with the head of research and development of AstraZeneca, Menelaos Pangalos to declare to Reuters that “The reason for the half dose is a happy occasion.”
At the same time, she quotes him Moncef Slaoui, head of the company Speed of light, from the United States Government’s Vaccine Development Program, which revealed that the second subset was limited to people 55 and younger. This was not made clear from the start, as the volunteers, under the age of 55, were a group at lower risk for severe symptoms of infection.
However, it is noted that the results of a previous study of the two phases of the vaccine published in the medical journal The Lancet showed that the vaccine produced a strong immune response in all age groups.
Extensive reports published in New York Times refers to what happened in recent days with respect to the coronavirus vaccine. And all this at a time when your ads are the center of attention AstraZeneca.
“This week’s announcements about make a cheap and easy vaccine for the coronavirus, which is 90% effective, they caused excitement. However, after the reveal of the preliminary results, AstraZeneca admitted that he had made a big mistake by Dose “It received some participants in clinical trials, raising questions about whether the impressive effectiveness of the vaccine will be verified in additional trials,” the report said.
“Scientists and pharmaceutical experts report that the error and a host of other irregularities and omissions in the way the company presented the data have weakened confidence in the reliability of the results. At the same time, US officials say that the The effects of the vaccine are not clear, in fact, it was the head of the federal vaccination committee, not the company, who first revealed that the results of the vaccine did not match the data of the elderly.
At the same time, experts note that the chances of the US and other regulators authorizing immediate use of the vaccine are reduced, marking a significant setback in the global campaign to tackle the pandemic.Add The New York Times.
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“I think they did a lot of damage to confidence in their show,” he said. Jeffrey Portz, investment bank analyst SVB Leerink.
On the other hand, the company representative Michelle Michexel assures that the tests “were carried out with the highest standards.” Even his head AstraZeneca Menelaos Pangalos, he referred to Wednesday’s research and development program.
In fact, he did not stop defending the company’s handling of evidence and public announcements. He said an associate made the dosing error and that as soon as it was discovered, regulators were immediately informed and agreed to continue testing the vaccine at a different dose.
Answering a question why AstraZeneca shared some details with his analysts financial world, officials, experts and not the public, responded “I think the best way to record the results is through scientific publications and not through newspapers.”
It is recalled that the AstraZeneca was the third company this month to announce encouraging preliminary results for the vaccine candidate. According to them, the vaccine appears to be up to 90% effective depending on the dose. Its average efficiency was around 70%, but questions immediately arose about the data.
What was wrong with the dose?
The treatment that appeared to be 90% effective was based on the fact that the participants received half the dose of the vaccine and after one month a full dose. The least effective treatment included two full doses. THE AstraZeneca had reported that fewer than 2,800 participants received the lowest dose treatment, while the second treatment received 8,900 participants.
The bigger questions were why there was such a big difference in effectiveness and why a smaller dose seems to have better results. Both of them AstraZeneca just as the Oxford researchers had no answer to give.
At the same time, critical information was lacking. Specifically, the company stated that the initial analyzes were based on 131 cases with symptoms that appeared in the participants. However, they did not explain how many of these cases were found in the group that received the treatment and how many in the group that received the placebo.
“The press release raised more questions than it answered,” said John Moore, professor of microbiology and immunology at Weill Cornell Medical University.
However, the fact that AstraZeneca collected results from two differently designed clinical trials, in Britain and Brazil, which is not common practice for drug and vaccine trials.
“I can’t understand where all the information is coming from and how it comes together,” said Natalie Dean, a biostatistician and vaccine testing specialist at the University of Florida. Natalie Dean even wrote on Twitter that the AstraZeneca and Oxford “score low for transparency and rigor in the vaccine trials they announced.”
In fact, at a time when the company’s shares were tumbling Monday, company executives made several private video calls with industry analysts. The details that were not disclosed were revealed during the contacts. This included how the Covid-19 incidents were divided into different groups. However, such disclosures to analysts are not considered unusual for the industry. However, they often draw criticism because they are not made public.
On Monday, November 23, Mr. Pangalos speaking to Reuters reported that the AstraZeneca some of the volunteers were not expected to receive half the dose. Like you said, this was done by mistake. He even described this mistake as a “happy circumstance” as it allowed the researchers to identify an even more promising dose.
Many experts believed that this error reduced the reliability of the results, since the initial announcement of the company did not mention the accidental discovery.
“It just came to our notice then. It did not endanger anyone. It was a dosing error, we were all moving very fast.” We corrected the error and continued the study without changes and agreed with the regulatory authorities to include these patients in the analysis. of data, “Pangalos said Wednesday.” What else can we reveal? In fact, it doesn’t matter if it was done by mistake or not, ”he added. Meanwhile, in a statement attributed to Oxford, its spokesperson AstraZeneca said the bug arose from a problem that has already been fixed.
Notably, on Tuesday, the head of the US initiative for rapid vaccine development, Manshev Slawi, noted another limitation in the company’s data. Specifically, in a video call he had with journalists, he expressed appreciation that the participants who received the half dose were 55 years old or younger. Finally, Mr. Pangalos confirmed this on Wednesday, saying that the participants received the half dose a few weeks before the error was discovered.
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