Saturday, September 12, 2020

Oxford vaccine trials to resume in UK after volunteer fell ill

Oxford University has confirmed that clinical trials of its Covid-19 vaccine will resume in the UK.

It is being developed with pharmaceutical giant AstraZeneca, who said the late-stage studies were briefly being halted on Thursday for an investigation into a reported side effect in a patient.

The vaccine is one of the leading contenders among the dozens in development around the world, and is being tested in thousands of people in Britain and the US as well as in smaller study groups in Brazil and South America.

Oxford University said in a statement ‘it is expected that some participants will become unwell’ in large trials like this one.

That view was echoed by the Government’s chief scientific adviser last week, who said what had happened in the trial was not unusual.

Health Secretary Matt Hancock welcomed the restart of the trials.

He tweeted: ‘Good news for everyone the Oxford vaccine trials are back up and running. This pause shows we will always put safety first. We will back our scientists to deliver an effective vaccine as soon as safely possible.’

The Oxford University statement read: ‘The ongoing randomised controlled clinical trials of the Oxford coronavirus vaccine ChAdOx1 nCoV-19 will resume across all UK clinical trial sites.

‘Globally some 18,000 individuals have received study vaccines as part of the trial.

‘In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.

On Sunday September 6 our standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee, and the national regulators.

‘All routine follow-up appointments continued as normal during this period.

‘The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, the trials will recommence in the UK.’

No details about the patient or the nature of the side effect were given.

But the New York Times has previously reported the patient had been diagnosed with transverse myelitis, an inflammatory syndrome which affects the spinal cord and is often sparked by viral infections.

Temporary holds on large medical studies are not uncommon, and looking into any unexpected reactions is a mandatory part of safety testing.

Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna and the other by Pfizer and Germany’s BioNTech.

Despite some figures, such as US President Donald Trump, insisting a vaccine will be ready in a matter of months, Oxford University has said a vaccine might not be ready before 2022.

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