AstraZeneca resumed the phase III clinical trials of the UK saying the UK’s health regulatory authority has confirmed it safe.
On Saturday, AstraZeneca started clinical Phase III trials in the United Kingdom and said that after UK medicines had been approved by the Health Regulatory Authority.
A major vaccine trial was discontinued this week after a participant experienced severe neurological symptoms. It was one of the first known embossments on the road to the most popular vaccine candidate, developed by AstraZeneca and the University of Oxford.
AstraZeneca resumed phase III clinical trials in the UK on Saturday, saying it was safe to do so after the UK drugs were confirmed by the Health Regulatory Authority.
The company said in a blog post that it could not release any medical information, only saying that the “standard review process triggered a voluntary suspension” and that it would work with health officials in other countries to determine when other medical tests could be resumed.
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Suspending a promising vaccine candidate, especially during a deadly outbreak, can be jarring. But this is not unexpected, it is the type for large-scale clinical trials. During clinical trials, patients are carefully monitored for any adverse reactions to the drug or treatment. If something goes wrong, they can pause and investigate, and then it is safe to do so.
“You take any group of 30,000 people, you see them in two or three months, and someone is going to get an illness you don’t expect,” Francis Collins, president of the National Institutes of Health, told the NBC. “Until you confirm that it is not linked to the test, it should be stopped medically.”
The seizure was first reported by STAT and then induced to stop when a patient was hospitalized with severe neurological symptoms in the United Kingdom. The symptoms were similar to those seen in people with inflammatory spinal myelitis.
The patient – who is expected to recover – got the vaccine as part of the test, but that does not mean the vaccine caused the disease.
The call with Investors
During a call with investors, AstraZeneca chairman Pascal Soriot told the STAT that it was, in fact, the second medical capture of the investigation. The first suspension is said to have been caused by a different person who came in with neurological symptoms – but in that case, they were diagnosed with multiple sclerosis, something unrelated to the vaccine.
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Researchers must dig into the data to see what happened in this new case, and it might take some time to do so. Meanwhile, other trials are looking for evidence of similar symptoms that may have developed during their trials.
Again, this is normal. If we want to complete a safe and effective vaccine, we cannot skip the steps of the research process. This is very common even for tests already done with multiple, small circuit tests. But for it, you mustn’t take my word.
In 2017, the Food and Drug Administration released a report that selected 22 different case studies, showing that a promising drug, treatment or vaccine candidate did not make that final reduction.
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In 14 cases, the treatments were not effective. For one, it is unsafe. In seven cases, they were both unsafe and ineffective. All of these devices, drugs and vaccines were made excellent in the laboratory and were even allowed to treat some other conditions. But the human body is complex.
As the FDA report notes, this model of failed trials shows how “logical hypotheses are unreliable without confirmation of medical evidence.”
In developing a vaccine to fight this epidemic, we must avoid past speculations and dangers and focus on the evidence – that is, stop for a moment and wait for science to catch up.
