London – Oxford University announced this weekend that it is resuming a trial for a coronavirus vaccine it is presenting with pharmaceutical company AstraZeneca. The measure came less than a week after the study was discontinued due to an imaginable side effect reported in a Briton. Patient.
In a statement, the university showed a reboot at all of its test sites in the UK after regulators gave the go-ahead after Sunday’s break.
“The indefinite review procedure has come to an end and following the recommendations of the indefinite protection review committee and uk regulator MHRA will resume trials in the UK,” he said.
The vaccine developed through Oxford and AstraZeneca is widely known as one of the leading serious contenders among the dozens of test-stage coronavirus vaccines worldwide.
UK Health Secretary Matt Hancock welcomed the reboot and said in a tweet it was “good news for everyone” that the test “is working again. “
The university said that in giant trials like this “some participants are expected to become ill and that each case will have to be thoroughly evaluated to ensure a full protection assessment. “
Dr. Anthony Fauci, the leading infectious disease expert in the US government’s coronavirus working group, is a major expert on infectious diseases. The U. S. agreed wednesday that the interruption of the transience of the Phase 3 vaccine trial at Oxford “is not uncommon. “Being alert to the possible side effects of any new vaccine is a component of the process, he said.
“This is one of the protective valves you have in clinical trials like this,” he told CBS This Morning. “So it’s a shame it’s happened. Let’s hope they can do it and get on with the rest of the rehearsal. “
Oxford said around 18,000 international people have won their vaccine so far. Volunteers from some of the most affected countries (Britain, Brazil, South Africa and the United States) are participating in the trial.
Brazilian fitness regulator Anvisa announced on Saturday that it had approved the resumption of the “Oxford vaccine” in the South American country after receiving official data from AstraZeneca.
Although Oxford reveals data on the patient’s disease due to the confidentiality of the participants, an AstraZeneca spokesperson said this week that a woman had developed neurological symptoms that caused the break. Specifically, the woman developed symptoms consistent with transverse myelitis, a rare inflammation. spinal cord.
The university presses that it is “committed to protecting our participants and the criteria for conduct in our studies and will continue to monitor protection closely. “
Disruptions in drug trials are a common place, however, suspension by transitoryness caused a sharp drop in the percentage value of AstraZeneca after Tuesday’s announcement.
The Oxford-AstraZeneca test was already suspended in July for several days after a player developed neurological symptoms that turned out to be an undiagnosed case of sclerosis that researchers declared unrelated to the vaccine.
During the third and final level of testing, researchers look for any symptoms of imaginable side effects that may not have been found in previous research with patients. Due to their giant size, studies are considered the most important exploration phase for tripping. Trials also evaluate efficacy by monitoring who gets sick and who is not among patients receiving the vaccine and those receiving a dummy injection.
Dr. Charlotte Summers, senior professor of intensive care medicine at the University of Cambridge, said the breakup is a sign that the Oxford team prioritizes protection problems, but that it generates “a lot of unnecessary speculation. “
“To combat the global COVID-19 pandemic, we want to expand vaccines and treatments that others feel comfortable using, so it’s imperative for public confidence that we stick to evidence and don’t draw conclusions until data becomes available. She said.
Scientists and stakeholders around the world, as well as experts from the World Health Organization, have sought to involve expectations of imminent progress for coronavirus vaccines, noting that vaccine trials are rarely simple.
Italian Health Minister Roberto Speranza welcomed the resumption of the vaccine trial, but warned that caution is still needed.
“Science is in paints to give effective remedies and vaccines globally,” he said. “In the meantime, the key remains our behavior. “
Italy, which is the zero point of the epidemic in Europe, is one of the leading countries investing in the AstraZeneca vaccine, but the United Kingdom and the United States, which have invested around $1. 2 billion in drug progression, are also heavily invested.
Two other vaccines are in the latter large stages in the United States, one manufactured through Moderna Inc. and the other through Pfizer and BioNTech from Germany.