A serious illness suffered by an Oxford University coronavirus vaccine trial participant was most likely “life-threatening”, a bioethics researcher says.
But that doesn’t mean the clinical trials will be scrapped.
AstraZeneca and Oxford University have suspended the late-stage study after a participant in Britain experienced what has been called a serious adverse reaction.
Dr Xavier Symons, a postdoctoral research fellow at Australian Catholic University’s Plunkett Centre for Ethics, said it was “concerning” the illness was described as a “serious adverse event”.
“The term ‘serious adverse event’ means life-threatening illness and admission to the ICU,” Dr Symons told The New Daily.
“It’s a serious illness – it’s more than just a headache or chills or fever or fatigue.”
Details about the sick participant’s exact symptoms have been kept under wraps. However, the person is expected to recover.
The future of the trials will depend on the outcome of an independent review.
“This is a routine action, which has to happen whenever there is an unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” AstraZeneca said in a statement.
“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.
“We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standard of conduct in our trials.”
Dr Symons said he was pleased AstraZeneca and Oxford University were being “very transparent” about the progress of their clinical trials
“It’s quite encouraging that they’re not cutting corners,” he said.
“We can be confident the eventual vaccine that’s delivered will indeed be as safe as other vaccines that are on the market, or at least we’ll know what the potential risks are.”
Image Credit: TND
Post by Amanda Scott, NA CEO. Follow her on twitter @tantriclens
Thanks to Heinz V. Hoenen. Follow him on twitter: @HeinzVHoenen