Oxford vaccine still on track for Australians despite halt in trials

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Sep 10, 2020, 08:51

The suspension of the much-vaunted Oxford COVID-19 vaccine trial after a participant became ill will not affect the timetable for rolling out a vaccine in Australia, the Federal Government says.

Phase three trials of the vaccine - developed by Oxford University and pharmaceutical company AstraZeneca - have been halted after a participant suffered an adverse reaction.

Health Minister Greg Hunt said the patient who was hospitalised is recovering in hospital.

The Oxford trial is one of two candidates in a $1.7 billion deal signed by the Federal Government to roll out COVID-19 vaccines to Australians next year.

Mr Hunt said he received a call from the Australian head of AstraZeneca this morning to report the patient would hopefully be released from hospital within 24 hours.

"The medical expert panel will now consider the patient's case, which is undiagnosed at this point in time and undetermined as to the cause of the particular event, but that this is part of the highest and most rigorous of safety oversight programs imaginable," he said.

"There is no change to the timetable for the delivery of the vaccine in Australia and they have no belief that it will be changed in terms of its nature, form or delivery, but they are always subject to the medical advice."

Associate Professor Nicholas Wood, of the Sydney University and National Centre for Immunisation Research and Surveillance, told nine.com.au the pause doesn't necessarily mean the vaccine is not safe.

"It's part of the normal process in trial vaccine. It is an indication they are not cutting corners," he said.

He said halting the trial was part of the regular "stopping rules" followed by vaccine researchers.

And even unrelated health events in vaccine participants - such as a broken bone - are regarded as adverse reactions that can lead to a pause.

Associate Professor Wood said the pause in the Oxford vaccine shows robust safety procedures are being followed.

"The actions have been appropriate and show they are meeting stopping criteria," he said.

And he said the halt in testing reflected the global interest in finding a COVID-19 vaccine.

Until yesterday's announcement, development of the Oxford vaccine had been powering ahead.

The next stage of trials is set to involve a much larger number of participants - 40,000 to 50,000 people.

What happened?

There's been no official statement on the nature of the illness that caused the trial to be paused.

We know it was a suspected adverse reaction in a participant in Britain; phase three trials for the Oxford vaccine have been taking place in Brazil and South Africa.

The New York Times has reported the participant was diagnosed with transverse myelitis, an inflammatory condition.

Associate Professor Wood said it was important to note that not all the 12,000 vaccine trial participants had been given the Oxford COVID-19 vaccine.

"To determine its effectiveness, researchers have given a control group a type of meningococcal vaccine that has been already licensed," he said.

In phase three vaccine trials, the age range of participants is much broader than the young, healthy adults who typically participate in early testing.

The Oxford vaccine includes people 70 years and older, which naturally increases the risk of temporally associated adverse results.

What next?

AstraZeneca will already be investigating the illness and external regulatory agencies such as the study's data safety monitoring board, the European Medicines Agency and the US Food and Drug Administration will be involved.

These independent bodies will review all parts of the investigation.

"They will be considering all factors including the time from when they became vaccinated to when they fell ill," Associate Professor Wood said.

But it will be particularly hard to prove the vaccine caused the illness with only one case.

The investigation could take up to two weeks and would resume if there were reassuring findings.

Meanwhile, the boss of the Australian company charged with manufacturing the Oxford vaccine has warned the Federal Government not to "bank on a vaccine".

CSL chairman Brian McNamee told the Herald Sun state and federal governments should not assume one was going to eventuate.

"We can't bank on a vaccine. I think the treatments are improving but we have to learn to live with COVID. We have to manage it," he said.

 
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