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With the coronavirus crisis around the world, all eyes are on each and every bump on the road to the end of the pandemic, so of course the news that researchers caused a joint rift in clinical trials of a leading vaccine candidate. COVID-19 made headlines Tuesday night.
Phase III global trials for the AZD1222 (formerly ChAdOx1) vaccine, developed through the University of Oxford and pharmaceutical company AstraZeneca, have been put on a “temporary” and “voluntary” hiatus for a “standard review process”, AstraZeneca said in a statement. .
According to the company, the break was triggered by a “potentially unexplained disease” in one of the thousands of participants affected in its trials. According to popular protocol, researchers will need to discontinue the trial to determine whether the disease is similar to exposure or not. experimental vaccine.
“In giant clinical trials, diseases will go through possibility and want to be independently tested,” he said. “AstraZeneca is running to speed up the review of the single occasion to minimize any possible effect on the trial schedule. “
Ever since the news broke, experts were quick to point out that such pauses are not unusual or unusual in late-stage clinical trials. In fact, this is a positive sign that proper safety checks and investigations are being carried out. Among the experts is infectious disease researcher Anthony Fauci, who, in an interview with CBS News Wednesday morning, said the breakup “is not rare at all. “
“We see this in general, for the most part,” Dr. Fauci said. “But you won’t know until you investigate it, [if] it’s an adverse occasion similar to anything else that just happened at the time the ongoing clinical trial was conducted “or the vaccine itself.
Fauci explained that according to popular protocol, when unexplained illnesses occur, it is not uncommon to suspend the trial, investigate the illness, and see if other illnesses or disorders have appeared, under the radar, in other trial participants.
“I think it’s vital to point out that this is why you have other stages of the trial, to find out if, in fact, those applicants are safe,” Fauci said. At this stage, that’s an example of the kinds of things that are done to make sure certain vaccines are safe, he said.
Among the large number of COVID-19 vaccine applicants in development, AZD1222 is one of the most promising applicants for an effective vaccine that opposes pandemic coronavirus. It is also one of the highest complexes under development, with Phase II/III clinical trials starting in the UK, Brazil and South Africa before this summer and a trial of another 30,000 people in the US. Last month. Trials are also planned for Japan and Russia.
The start of the Ars COVID-19 vaccine: more than one hundred in preparation, 8 in clinical trials The vaccine is a vaccine based on a viral vector. In other words, it’s a bit of the pandemic coronavirus, SARS-CoV-2, in a different, innocent virus that is delivered to the immune system. The innocent virus in this case is an adenovirus that causes mild infections in chimpanzees and is further designed not to be reflected in human cells. This adenovirus carries the SARS-CoV-2 spike protein, which is essential for infection and is believed to stimulate resistant and protective immune responses.
In early animal trials, AZD1222 monkeys of the progression of pneumonia after exposure to SARS-CoV-2, and in an initial clinical trial involving 1077 people, AZD1222 stimulated potentially protective immune responses and sometimes seemed safe. adding pain, fever, chills, muscle aches, headaches and discomfort were common, but no serious side effects were reported.
AstraZeneca has been silent about the illness that triggered the hiatus in ongoing trials, which was first reported via STAT News. An unnamed source first told STAT that the disease had occurred in a player in the UK and that the user had been cured.
It was temporarily revealed that the disease may simply be transverse myelitis, which was first reported via an anonymous New York Times source. Transverse myelitis is an inflammation of the spinal cord that can be triggered by a number of conditions, adding inflammatory disorders of the formula (such as multiple sclerosis), vascular disorders, and infections caused by bacteria, viruses, parasites, or fungi. In rare cases, it can be activated by a vaccine. AstraZeneca declined to verify any of those main points related to the sick participant. In a statement to The Times, the corporate said that “the occasion is being investigated through an independent committee and it is too early to conclude the express diagnosis. “
But in a call to a personal convention with investors on Wednesday, AstraZeneca CEO Pascal Soriot showed that a British woman who won the vaccine (not a placebo) had neurological symptoms consistent with transverse myelitis, according to a follow-up article by STAT. is and is expected to be released from the hospital on Wednesday.
According to the National Institutes of Health, transverse myelitis often causes weakness in the limbs, pain, sensory disturbances (numbness and tingling) and bowel and bladder disorders. An estimated 1,400 other people in the United States are diagnosed each year. there is no cure, but it can be treated with corticosteroids, other medications and physical therapies. Most other people, at least partially, end up with moderate disabilities, such as difficulty walking, nerve sensitivity, and bladder and bowel problems.
Interestingly, Soriot also noted the appeal to investors that this was in fact the time the trial was adjourned. He is also said to have been suspended in July after a player developed neurological symptoms and was subsequently diagnosed with multiple sclerosis. were not related to the vaccine.
It is not known whether the new disease in British women is also related. So far, little can be learned from the breakup other than that AstraZeneca is following protection procedures, a point so emphasized by Soriot.
“At AstraZeneca, we place the science, safety and interests of society at the center of our paintings,” Soriot said in a statement. “This break from transitoryness is living evidence that we are following these principles while we are single in one of our checks. Sites are evaluated through a panel of independent experts. We will be guided through this committee on when trials can be restarted, so that we can continue our paintings as soon as possible to deliver this vaccine in a broad, equitable and une benefit-free manner during this pandemic.
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