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Coronavirus: Oxford vaccine trial ‘to resume in days’ after side-effect checks

Vaccine trial volunteer with symptoms of transverse myelitis ‘improving’, says AstraZeneca CEO

Kate Ng
Thursday 10 September 2020 18:01 BST
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The coronavirus vaccine trials conducted by Oxford University are reportedly set to continue, days after they were paused for an urgent investigation into potentially risky side effects.

AstraZeneca, the company developing the vaccine with researchers from the University of Oxford, said on Tuesday it had put on hold late-stage trials to allow an independent committee to review safety data.

The pause was announced after a volunteer reportedly began suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.

The drugmaker said in a statement that the trials were paused “voluntarily”, describing it as a “routine action” that will be investigated to ensure the “integrity of the trials” is maintained.

AstraZeneca’s CEO, Pascal Soriot, said during a private conference call with investors on Wednesday that the participant who fell ill did not yet have a confirmed diagnosis but was improving and was on course to be discharged from hospital as early as last night.

Transverse myelitis is an inflammation of both sides of one section of the spinal cord and can be triggered by viral infections. It can cause pain, muscle weakness and sensory issues.

People who suffer from the condition usually recover within a few weeks and is often treatable with steroids, but it can sometimes persist for months, according to the Mayo Clinic.

According to health industry news site Stat, which first reported the pausing of the trials, Mr Soriot also confirmed the clinical trial was halted once in July after a participant experienced neurological symptoms and was diagnosed with multiple sclerosis.

The participant’s condition was deemed to be unrelated to the vaccine treatment, he said.

The trial was paused across the UK, Brazil, South Africa and the US, stoking nervousness around the development of a vaccine for a pandemic that has brought much of the world to its knees.

Scientists said such pauses were not uncommon but warned that each pause must be taken seriously.

Sir Jeremy Farrar, director of the Wellcome Trust and member of Sage, told BBC Radio 4’s Today programme: “For me it underlines just how important it is that these vaccine trials are done properly, that they have independent oversight, that the regulator is involved and we can trust and support that regulator and that we take these sorts of pauses seriously.”

The health secretary, Matt Hancock, also sought to assuage concerns about the pause and stressed that clinical trials are often halted “whenever they find something that they need to investigate”.

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