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Oxford University and AstraZeneca plc has resumed the UK trial of an experimental Kovid-19 vaccine after a participant was held up over concerns that he was ill.
Oxford said in a statement that the UK Medicines Health Regulatory Authority recommended that the study be resumed after an independent review of safety data. It refused to reveal details about the volunteer’s illness.
Although temporary interruptions are common in vaccine trials, the closely-watched Astra-Oxford study found concern about the viability of one of the fastest moving experimental shots seeking protection from the epidemic. The race to develop a Kovid-19 vaccine has been narrowed to a process that typically lasts a decade, with data from the final phase of trials next month.
The statements of Astra and Oxford on Saturday did not say anything about the status of tests outside the UK trials of the Oxford vaccine in the US, Brazil, South Africa and India before being halted following a security review.
A representative for The US National Institutes of Health could not immediately be reached for comment. A spokesperson for AstraZeneca declined to comment.
AstraZeneca CEO Pascal Soriot said Thursday that the vaccine may still be available by the end of the year. Was an independent security board Reviewing whether the participant’s illness was caused by the vaccine or unrelated, he said.
Soriot said it was unclear whether the participant had a condition known as transverse myelitis, a suspected diagnosis. NIH director Francis Collins told a Senate committee on Wednesday that the trial was halted due to a “spinal problem”.
“We cannot disclose medical information about the disease for reasons of participant confidentiality,” Oxford said. “We are committed to the safety of our participants and the highest standards of conduct in our study and will continue to closely monitor safety.”
Oxford said some 18,000 people received “study vaccines” as part of the test. It began a large Phase 3 trial in the US in late August, aiming to recruit 30,000 people.
AstraZeneca is one of several companies participating in the US government’s Operation War Speed Program to fast-track the coronovirus vaccine. In May, the company signed a $ 1.2 billion deal with the US to support clinical studies and supply 300 million doses of the vaccine. It has promised to make the vaccine available on a no-profit basis during the pandemic and has signed deals to supply around 3 billion doses worldwide.
Oxford began human trials of its shot at around 1,100 volunteers on 23 April and quickly advanced to a large-scale study in Britain in late May, involving more than 10,000 people, including those over the age of 55. People were. Researchers are finding quite a lot of Kovid-19 cases are effective in the control group over the vaccination group to show the shot.
In Britain, the rate of infection had begun in May, with testing starting in May, making it difficult to demonstrate whether the vaccine works. In recent weeks, new cases are climbing again.
In July, Oxford reported preliminary results showing the vaccine’s protective neutralization antibodies and increased levels of immune T-cells that target and destroy infected cells. It did not report any serious adverse events as part of its 1-2 phase trial. The researchers pressed forward with testing the two-dose regime after detecting a strong response in 10 volunteers. It is unclear whether the participant who fell ill had two doses or one.
– assisted by Cynthia Coons
(The fourth paragraph adds details on the resume.)