The company also confirmed this was not the first time the trial had paused due to safety concerns.
“We can also confirm that there was a brief trial pause in July while a safety review took place after one volunteer was confirmed to have an undiagnosed case of multiple sclerosis, which the independent panel concluded was unrelated to the vaccine,” an AstraZeneca spokesperson said in a statement.
They said reports claiming to be based on comments by the company’s CEO confirming a participant in the clinical trial suffered from transverse myelitis were “incorrect”.
“He stated that there is no final diagnosis and that there will not be one until more tests are carried out,” the spokesperson said.
“Those tests will be delivered to an independent safety committee that will review the event and establish a final diagnosis.”
Yesterday, the late-stage trials of the Oxford University vaccine candidate were put on hold in what AstraZeneca described as a “routine action which has to happen whenever there is a potentially unexplained illness”.
ANU infectious diseases expert professor Sanjaya Senanayake said this development showed the importance of waiting for the independent inquiry.
“They will look at what happened with this volunteer and see if there are any other similar cases in the trial,” he said.
“Now we know that they paused the trial earlier in the year after the undisclosed case of MS, it shows that proper protocols were in place and working well.”
Professor Senanayake said the size of the trial was a factor.
“Given this trial is so large, in tens of thousands of people with different health conditions, you have to be careful to work out if the health issue is due to the vaccine or not,” he said.
“If it is a spinal cord issue that has arisen in a volunteer, it could be many things with various possibilities such as lesions.
“Even if it does turn out to be the inflammatory condition transverse myelitis, if no one else gets it, it’s likely that the trial will continue in a few weeks.”
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