AstraZeneca did not turn over coronavirus vaccine trial safety data to the US Food and Drug Administration (FDA) for one month, a new report claims.Th
AstraZeneca did not turn over coronavirus vaccine trial safety data to the US Food and Drug Administration (FDA) for one month, a new report claims.
The late-stage study, being conducted with Oxford University, was put on hold on September 9 when a British participant was rushed to the hospital after suffering a serious reaction that triggered spinal cord inflammation.
Testing has since resumed at all other sites, but the US arm of the trial remains paused.
Officials say the FDA was waiting for information tor review so it can determine whether or not the illness was linked to the experimental vaccine.
According to CNN, a source says this is because the drugmaker did not give data requested by US regulators until last week.
AstraZeneca reportedly took one month to get coronavirus vaccine trial safety data to the FDA, delivering it just last week after the study was paused. Pictured: A volunteer participates in the AstraZeneca vaccine trial in Oxford, England, July 7
CNN reports the delay was due to data being stored differently at the European Medicine Agency compared to the FDA. Pictured: AstraZeneca’s offices in Macclesfield, Cheshire, England July 21
The source claims the delay is due to data being stored differently at the European Medicines Agency – which evaluates and supervises medicinal products in Europe – than it is at the FDA.
‘They had to convert data from one format to another format,’ the unnamed source told CNN.
‘It’s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted.’
An internal safety report revealed the British patient was diagnosed with transverse myelitis, an inflammation of a section of the spinal cord.
The condition damages the myelin sheath, an insulating barrier of fatty protein that protects the nerves, and interrupts messages sent by spinal cord nerves.
This results in pain, weakness, abnormal sensations, and problems of the bladder and bowel – and can even lead to permanent paralysis.
Transverse myelitis can be caused by several conditions including infections such as influenza and immune system disorders.
Around 1,400 cases are diagnosed in the US each year, according to the National Organization for Rare Disorders.
‘This is a serious adverse event. It led to hospitalization but the reason it stopped the trial…is because the real cause of transverse myelitis is imperfectly understood,’ Dr William Schaffner, a professor of preventive medicine and infectious diseases at the Vanderbilt University Medical Center in Nashville, told DailyMail.com in an interview last month.
‘It’s thought to be due to an immune response. Yes, it is theoretically possible that a vaccine could induce this aberrant immune response and cause transverse myelitis. This is exactly the sort of response that would pause the trial and then lead the data safety monitoring board to do an investigation.
Dr Robert Califf, who served as FDA commissioner from 2016 to 2017, told CNN he does not believe a technology issue caused the delay.
He said he believes the FDA requested more data than AstraZeneca originally provided.
‘FDA may be asking for specialized tests or some kind of further follow up,’ Califf said.
‘And it’s not just a matter of raw data. They want to hear expert opinions and aggregate all of this, and that can take some time.’
During a telebriefing on Friday, Dr Paul Mango, deputy chief of staff for policy at the US Department of Health Human Services, said there may be some updates on the trial’s future this week.
‘FDA continues to review safety information, and we’ll just have to see over the next week or so where that turns out,’ he said.
AstraZeneca did not immediately reply to DailyMail.com’s request for comment.