Clinical trials on the University of Oxford’s COVID-19 vaccine have been halted on Tuesday.
“Our standard review process was triggered and we voluntarily prevented vaccination by an independent committee to allow the review of safety data,” the company said in a statement. “It is a routine action that occurs when a potentially unexplained disease occurs in a single test while it is examined, while ensuring that we maintain the integrity of the test.”
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The statement continued: “In large trials the disease will be coincidental, but it should be reviewed independently to be carefully screened. We expedite single-event review to minimize any potential impact on the test deadline We are committed to safety. Our participants and the highest standards of conduct in our trials. “
AstraZeneca, which is working with the University of Oxford on a coronovirus vaccine, began its phase 3 clinical trials in the US last week. NBC News has confirmed that the halt has affected test sites in the US
Researchers determine that when a serious adverse event occurs due to the vaccine, it is determined that “not uncommon, but unheard of,” Director of Children’s Vaccine Education Center in Philadelphia, Dr. Paul Offit said.
An infectious disease specialist and director of the Mayo Clinic’s Vaccine Research Group in Rochester, Minnesota, said in an email to NBC News. “Serious reactions occur in vaccine trials,” said Gregory Poland. “Typically, when these incidents occur, tests are stopped, data is collected, and an independent data monitoring and security board reviews the details to determine whether to resume testing. Or change it in some way. “
“Often these incidents are coincidental, but these precautions are necessary to ensure the safety of trial participants,” Poland said.
Offit, who was on the Food and Drug Administration’s Vaccine Advisory Committee, said, “Presumably, we should hear more in a few days about what the problem was.”
The Oxford trial was the third Phase 3 trial to begin in Pfizer, USA, and Modern began its Phase 3 trial in late July and has already enrolled around 30,000 volunteers.
The Oxford Vaccine uses a type of virus called adenovirus that teaches the immune system how to make antibodies to attack the so-called spike proteins that are coronoviruses. It is the spike protein that allows the virus to infect human cells.
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Meg Tirrell has contributed.