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It is a stop, useless to go around it. But it had been clear for some time that vaccine fever could have a hard time and that certain dates are impossible. AstraZeneca is temporarily suspending testing of the coronavirus vaccine it is developing with the University of Oxford to investigate a “potential unexplained” reaction in one of the participants. This was announced by the company, underlining that the shutdown is “a routine action that is taken during tests in the event of an inexplicable reaction.”
Everything happens, AstraZeneca explains, to “ensure the integrity of the testing process.” Phase 3 to test the vaccine is underway at dozens of US sites, while phase 2/3 studies had previously started in the UK, Brazil and South Africa. An AstraZeneca spokesperson said that “the company’s standard review process has caused a pause to allow review of safety data.”
For now, it’s unclear if AstraZeneca itself ordered the voluntary suspension or if it was ordered by those who control the testing process.
“Our standard review process has been activated and we have voluntarily discontinued vaccination to allow review of safety data by an independent committee,” the company said in a statement. “This is a routine action that has to happen whenever there is a potentially unexplained illness” during trials. “In large studies, illnesses occur by chance, but they must be independently reviewed for careful verification. We are working to expedite the review of a single event to minimize any potential impact at the time of study. We are committed to safety. of our participants and the highest standards of conduct in our trials. “
Coronavirus, the timing of the vaccine cannot be safe
AstraZeneca, which is working with the University of Oxford on a coronavirus vaccine, began its phase 3 clinical trials in the United States last week. Temporarily suspending a trial while researchers determine whether a serious adverse event was caused by a vaccine is “rare, but not unheard of,” said Dr. Paul Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia.
“Serious reactions occur during vaccine trials,” he wrote in an email to NBC News Dr. Gregory Poland, an infectious disease expert and director of the Mayo Clinic Vaccine Research Group in Rochester, Minnesota. “Typically when these events occur, testing is suspended, data is collected, and an independent data security and monitoring committee reviews the details to determine whether to resume the process or modify it in some way.” Everything is regulated, there are steps to follow with zeal.
More details should be provided in the next few days on what the specific issue was that led to the suspension of testing for the AstroZeneca vaccine. The Oxford vaccine relies on adenovirus-derived viral vectors to teach the immune system how to make antibodies to attack the so-called coronavirus spike protein. It is precisely the spike protein that allows the virus to infect human cells.
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