American COVID-19 vaccine causes 'unexplained illness' in test subject - ForumDaily
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American COVID-19 vaccine causes 'unexplained illness' in test subject

AstraZeneca, one of the companies involved in the development of a coronavirus vaccine, has suspended its research due to the "unexplained illness" of one of the test participants. Writes about it USA Today.

Photo: Shutterstock

The company has suspended its clinical trials of the COVID-19 vaccine worldwide and is now investigating an adverse reaction from a UK contributor.

It is unclear how long the research shutdown will last. Sometimes purely random reactions occur during a trial, but if they are severe enough, research is delayed until they are fully understood.

“We are working to expedite the review of this incident to minimize any potential impact on trial timing,” AstraZeneca said in a statement. The company is testing a vaccine originally developed at Oxford University. “This is a routine action that should occur whenever a potentially unexplained condition is detected in one of the trials while it is being investigated, ensuring that the integrity of the trials is maintained.”

This incident represents the first major mistake on a remarkably smooth track of historically rapid vaccine efforts around the world. However, in large scale, critical phase 3 clinical trials, real problems are most likely to arise.

In earlier small trials, none of the various candidate vaccines produced very severe reactions. But larger studies like AstraZeneca may have rarer reactions, so they are done before a vaccine is approved.

On the subject: COVID-19 vaccine: how to become a volunteer and take part in trials

In such a large trial, participants were divided into active vaccine recipients and placebo recipients. It is not known what the patient received.

In the United States, in addition to the AstraZeneca trial, which is now paused, two other large-scale COVID-19 vaccine trials are underway: one by the German company Pfizer and BioNTech, and the other by the biotech firm Moderna.

The medical and biotech news site STAT reported that the person's exact condition is unknown, although it is expected to recover.

The company must now try to figure out the cause of the reaction, said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tennessee.

“It's entirely possible that under their protocol, once they figure this out, the company could refer the investigation to the Data Safety Oversight Board, an external group of experts who would then conduct an investigation,” he said.

It is very important to show whether the adverse reaction was caused by a vaccine or coincidence.

Schaffner offered a hypothetical example of how such a shutdown of vaccine trials could occur. If, for example, one of the participants in a vaccine trial had a heart attack three days after vaccination and was admitted to the hospital, “this immediately qualifies as an adverse event. We do not know if this is due to the vaccine or not, but it will most likely be some kind of trigger that could pause research while the Data Safety Oversight Commission investigates. "

AstraZeneca said in a statement: “As part of the ongoing randomized controlled global trials of the Oxford coronavirus vaccine, we have voluntarily suspended vaccinations to allow an independent committee to review the safety data. This is a common activity that should occur every time a potentially unexplained disease appears in one of the trials while it is being investigated to ensure the integrity of the trials. In large trials, diseases occur by chance but need to be tested. We are working to expedite this review to minimize any potential impact on test timing. We are committed to ensuring the safety of our participants and maintaining the highest standards of conduct during testing. ”

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