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.”
He added some of the big questions the independent review will seek to answer include:
- Did this adverse event actually occur as a result of the vaccine, or was it something else that caused it?
- Does the person have a pre-existing condition?
- Is it a placebo that’s caused this?
“These things do happen in clinical trials, so it’s not an unexpected occurrence,” Dr Symons said.
“We want to hope it doesn’t cause a massive delay.”
Australia has ordered 33 million doses of the AstraZeneca vaccine to be rolled out from early 2021 if the trials are successful.
The federal government is hoping to gain early access to 3.8 million doses for distribution in January.
Deputy chief medical officer Nick Coatsworth said the delay did not necessarily mean the vaccine deal was dead but the adverse reaction needed to be investigated.
He isn’t worried about the trial being put on hold and praised the transparency of those testing the vaccine.
“I’m going to wait to see exactly what the adverse reaction was and whether they attribute it to the vaccine,” Dr Coatsworth said on Wednesday.
Earlier this week, Prime Minister Scott Morrison announced a $1.7 billion coronavirus vaccine deal.
Mr Morrison promised to make two vaccines – the Oxford University and AstraZeneca drug, and another being developed by the University of Queensland and CSL – free for every Australian.
He said both vaccines would need to be proven safe and effective before being made available to the public.