Updated: December 3, 2020 at 2:15:39 p.m.
The half-dose followed by the full dose is not the intended method. (UP by AP Xford UP)
Error in Oxford vaccine AstraZeneca-University tests, AZD 1222, the way in which clinical trials of vaccines have been handled during an epidemic has been questioned. This is the reason why it is important, and what needs to be done now.
What was wrong?
On Monday, Ox Xford and AstraZeneca said the effectiveness of AZD1222 could be up to 90% – when given half a dose after a full dose a month later. What they initially did not disclose was that these findings were the result of error. The nearly 1,000,000 participants in the UK on whom this result is based should never be underestimated in the first place.
Doubts have been raised in the revelation that these experiments are being carried out by Lation Strazeneka and Ox Xford, with some scientists pointing to a lack of transparency in the whole process.
The Oxford vaccine mistakenly raises questions about how clinical trials are conducted during an epidemic.
“Except for the US-based trial, I am not aware of the details of how these tests are monitored. Is there a centralized DSMB (Data Safety and Monitoring Board)? Do they combine accrued data? Looks like they’ve done joint events in Brazil and the UK. Why not other countries? Natalie E Dean, a biostatist from the University of Florida, tweeted on Wednesday.
“And it is not desirable to report a secondary analysis that was not pre-specified (as it appears to be based on a dosing error). If they want to get half a dose recognized, they should wait until an amazing result comes. Otherwise, we can get into the ‘evidence limbo’, “he tweeted.
India’s trial is not the result
AstraZeneca’s efficacy results were based on tests conducted in the United Kingdom and Brazil. It does not include similar vaccine tests conducted by the Serum Institute in India. The results of the Indian tests are expected to come out in December.
The report states that U.S. Regulators such as the Food and Drug Administration are making development uncertain whether they will authorize the use of the emergency, a report said. The New York Times.
“We need to see that this amount of data (from the low-volume group) is potentially useful for regulatory submissions in the strictest sense, because, I understand, you cannot use data that is not referenced in the protocol. They may have notified regulators, but this is not exactly ‘per protocol’ or ‘intended to cure’ analysis, which is usually done in clinical trial analysis, said vaccine scientist Professor Gagandeep Kang. Indian Express On thursday.
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What was Oxford’s vaccine error?
Why did you make a mistake
Oxford says that due to the “difference in production process” for the vaccine batch chess initially used for the 3-stage trial in the UK, the dose given to 2,7411 participants in the UK was overestimated, resulting in half the dose being administered as the first dose. .
“We have different ways of measuring vaccine concentrations and when it was clear that low doses were being used, we discussed this with the regulator, and agreed to a plan to test both low dose / high dose and high dose / high dose. , Allows us to include both approaches in the Phase III hearing, ”the university said. “Methods for measuring concentrations have now been established and we can ensure that all vaccines are now the same.”
Dr. Error Jessani, researcher and teacher of bioethics and public health, co-founder of the Forum of Medical Ethics Society and editor of the Indian Journal Medical f Medical, Dr. Ethics.
“One of the hurdles with which vaccine trials are conducted during epidemics is that they are trying to narrow down the various stages of vaccine development. The second is that companies are making efforts with each other to capture the market as soon as possible.
Why does the Oxford vaccine go wrong?
What are the checks and balances for such errors?
In this case, the error was brought about a possible positive finding that AstraZeneca intends to study further in U.S. hand tests, but it could end badly if the dosing was the other way around.
“In this case, the direction in which the error occurred was not an accident. Overdose is likely to cause harm. Underdoses don’t usually happen, “said Dr. Kang.
“In clinical trials, everything is precisely protocolized, and it should be the same for all participants in the trial. In general, you don’t see this level of error happening, “said Dr. Jesse.
Dr. Protocol deviations are still common in clinical trials, Kang said.
Ox Xford Vaccine Error: What are the checks and balances for such errors?
“Improper labeling of samples, issues with data quality, your freezer breaks down – all this is bound to happen. Whether mistakes or deviations can make a difference or not, you can stop studying, check what’s going on, and then move on, ”he said.
“Mistakes happen. The point is that the study protocol is a guiding document that is an approach on how to do and monitor what to do to prevent errors as much as possible. In any type of clinical trial, despite the best efforts, it is likely that you will have protocol deviations. You have to record that, ”he added.
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Should these participants be excluded from the trial?
Given the error that the first dose of this vaccine was to be administered, according to Dr Kang, these participants are considered unethical to remove the ongoing trial. “You have recruited these people by saying that your voluntary, philanthropic spirit will greatly benefit the people. Can you afford to say, ‘Sorry, but all your efforts have been in vain because we made a mistake so now, we’ll stop?’ ”He said. “You don’t really know what the right dose is for this vaccine yet, and this could turn into an opportunity to understand more about the vaccine,” he said.
However, he said, “I want there to be more transparency – maybe it’s too much to ask Big Pharma, but, in this crisis situation, with false information and argument everywhere, by publishing protocols and papers and sharing information. Has been open. The more detailed, the more helpful it will be. ” થયેલ Express Express is now on Telegram
Does Oxford’s vaccine error raise questions for India’s CoveShield?
Does this raise questions for Covishield of India, which is based on AZD1222?
According to some experts, this should not be called into question.
“Weapons in the UK and Brazil come with more than 60 per cent efficacy, which means the vaccine is working … and we set a target of 0 per cent under the guidance of the WHO, FDA and DCGI,” said Dr K Kang. .
“But regulators will have to wait until the data is reviewed and make sure this is a vaccine, as it is important to understand that regulators will get more details than scientists can read in a scientific journal.”
For Serum Institute India F India (SII), which is now testing Covishield in India, all that is needed now is to submit a “quick” protocol for additional studies, which can test the vaccine with half a dose.
“Serum should be asked to share all the data from the Strazeneca study with DCGI and a quick vaccination study should be done on Covishield to move it forward – low doses mean we can double the amount.” , ”Said Dr. Kang.
At the same time, the incident should also be a wake-up call for greater transparency in the way Indian companies conduct hearings.
“We also don’t know at what dose the Serum Institute tests Covishield here… I can read the full protocol of AstraZeneca’s clinical trial and rule on the error. Can you do Serum Institute for India’s F Indiana protocol? ”Said Dr. Jesse.
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. The Indian Express (P) Ltd.
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