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The University of Oxford and AstraZeneca Plc has restarted a UK study of the experimental Covid-19 vaccine after it was stopped due to concerns about a participant who became ill.
The British Medicines Regulatory has recommended that the study be resumed after an independent review of safety data caused a pause on September 6, Oxford said in a statement. He declined to reveal details about the volunteer̵
While temporary stops are common in vaccine trials, the disruption of a closely monitored Astra-Oxford study has raised concerns about the viability of one of the fastest-moving experimental photos seeking protection from the pandemic. The Covid-19 vaccine development competition is compressing what is usually a ten-year process in a matter of months, with data from the final stages of the research expected next month.
Astra and Oxford’s statements on Saturday said nothing about the state of tests outside the United Kingdom. Oxford vaccines have been tested in the United States, Brazil, South Africa and India before being paused after a safety review.
Representative The U.S. National Institutes of Health could not immediately be reached for comment. An AstraZeneca spokesman declined to comment.
AstraZeneca CEO Pascal Sorio said on Thursday that the vaccine could still be available by the end of the year. It was an independent safety council reviewing whether the participant’s illness was caused by the vaccine or not, he said.
Soriot said it was unclear whether the participant had a condition called transverse myelitis, a presumptive diagnosis. NIH Director Francis Collins told the Senate committee Wednesday that the trial was halted due to a “spinal cord problem.”
“We cannot disclose medical information about the disease due to the confidentiality of participants,” Oxford said. “We are committed to the safety of our participants and the highest standards of conduct in our studies, and we will continue to monitor safety closely.”
Oxford said about 18,000 people received “vaccine studies” as part of the trials. At the end of August, a large phase 3 court trial was launched in the United States to enroll 30,000 people.
AstraZeneca is one of several companies involved in the US government’s Warp Speed program for rapid tracking of the coronavirus vaccine. In May, the company struck a $ 1.2 billion deal for the United States to support clinical trials and deliver 300 million doses of the vaccine. It has pledged to make the vaccine non-profit during the pandemic and has arranged deals to deliver nearly 3 billion doses worldwide.
Oxford began human trials by shooting nearly 1,100 volunteers, and in late May quickly moved on to a large-scale study in Britain involving more than 10,000 people, including those over the age of 55. The researchers looked for a significantly higher number of Covid-19 cases in the control group than in the vaccinated group to show that the shot was effective.
The trial began just as infection rates in the UK began to fall in May, making it difficult to prove whether the vaccine works. In recent weeks, new cases have risen again.
In July, Oxford announced initial results showing that the vaccine increased levels of protective neutralizing antibodies and immune T cells, which target and kill infected cells. He did not report any serious adverse events as part of his phase 1-2 trial. The researchers went ahead with testing the two-dose regimen after finding that it gave a stronger response in 10 volunteers. It is not clear whether the participant who became ill had two doses or one.
“With the help of Cynthia Koons.”
(Adds details of the resumption in the fourth paragraph.)