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In the midst of these experiments, the British company AstraZeneca, which developed the Corona vaccine, jointly with the University of Oxford, admitted that there was a manufacturing error, which raises questions about the initial results of the experimental vaccine.
This announcement came a few days after the company confirmed that the vaccine produced is highly effective.
In details, the company explained that the group of volunteers who got a lower dose of the vaccine appeared to be protected much better than the volunteers who got two full doses. Confirming that in the group with low doses, the vaccine appeared to be 90% effective, and in the group that received two full doses, the vaccine appeared to be effective by 62% combined, so that the final results are that the vaccine is 70% effective.
However, the way in which the results were accessed and reported by the companies led to specific questions from the experts.
Partial results announced last Monday are from large studies that were underway in the United Kingdom and Brazil, with the mission of determining the optimal dose of the vaccine, as well as examining safety and efficacy.
Multiple groups and doses were tried in the volunteers, then compared to others who had been given the meningitis vaccine or a saline injection.
Did the researchers intend to give half a dose?
Before they begin their research, the scientists explained all the steps they would take and how they would analyze the results, stressing that any deviation from this protocol could put the results into question.
However, Oxford University announced in a statement Wednesday, that some of the vials used in the experiment did not have the correct, concentrated amount of vaccine, so some volunteers got half a dose.
The university said it discussed the issue with the organizers and agreed to complete the final phase of the trial with two groups.
The statement also stated that the manufacturing problem had been corrected.
What about the results themselves?
Experts report that the small number of people participating in the low dose group makes it difficult to know whether or not the efficacy observed in the group is real.
AstraZeneca said that about 2,741 people received half a dose of the vaccine, followed by a full dose, while a total of 8,895 people received two full doses.
And another factor, none of the people in the low dose group was older than 55, so it’s an incomplete experience, because younger people usually tend to have a stronger immune response than the elderly, so younger people in the lower dose group may be: The reason it appears to be more effective is not the size of the dose.
David Salisbury, a participant in the Global Health Program at the Chatham House Research Center, revealed that another point of confusion came from the decision to pool results from two groups of participants who received different dose levels to reach an average of 70% efficacy. He said: “I have done two studies with different doses, and finally reached a compound that does not represent any of the doses .. I think many people face a problem with that.”
Why is a smaller first dose more effective?
The Oxford researchers say they are not sure and are working to uncover the cause.
Sarah Gilbert, one of the Oxford scientists who led the research, explained that the answer might be related to providing the right amount of vaccine to stimulate the best immune response. She said: “The size of the dose is not a little or not a lot, as a lot may give you a bad response, so you only want the right amount, you will not get perfect the first time.”
What are the next steps?
Details of the trial results will be published in medical journals and presented to the UK regulators so that they can determine whether or not to allow the vaccine to be distributed. These reports will include a detailed explanation that includes demographic information and other information about who has contracted the disease in each group. A more complete picture of the effectiveness of the vaccine.
It is noteworthy that the British laboratory, AstraZeneca, had announced, last Monday, in a statement, that the vaccine against Covid-19, which it is jointly developing with the University of Oxford, is 70% effective in preventing disease.
The lab said they are tentative results of clinical trials conducted widely in the United Kingdom and Brazil.
However, he pointed out that this vaccine is less convincing than the Pfizer / Bionic and Moderina vaccines, whose effectiveness exceeds 90%, as it uses more traditional technology than the competing vaccines, which makes it less expensive and easier to store, as it does not need to be preserved at a low temperature.
The company considered in the statement that its vaccine is “highly effective” to prevent disease, especially since no participants in the trials had any severe types of disease and no one was taken to hospital.
While the British authorities stressed at the time that the data should be shared with the Medicines and Healthcare Products Regulatory Agency, as it needs to ensure that it is effective and safe, of course.
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