Covid: Oxford vaccine trial resumes after unexplained illness in volunteer

UK regulator deems trials safe to resume after urgent probe into potentially harmful side effects

Andy Gregory
Saturday 12 September 2020 15:29
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Trials of the Oxford coronavirus vaccine will resume across the UK, the university has said.

It comes days after they were paused for an urgent investigation into potentially risky side effects after a volunteer fell ill.

The independent review process has concluded and, following the recommendations of the review committee and the UK regulator, the MHRA, the trials will recommence in all clinical sites across the country, the University of Oxford said in a statement.

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

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

AstraZeneca - the pharmaceutical giant co-developing the inoculation - said trials were paused “voluntarily”, describing it as a “routine action” that will be investigated to ensure the “integrity of the trials” is maintained.

The trial was paused across the UK, Brazil, South Africa and the US, in a move that scientists said were not uncommon, but should be taken seriously.

“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,” Sage member and Wellcome Trust director, Sir Jeremy Farrar, told the BBC’s Today programme.

The vaccine is made from a weakened version of a common cold virus which infects chimpanzees. It has been genetically changed so that it is impossible for it to grow in humans.

Health secretary Matt Hancock told LBC on Monday: "The best-case scenario is that [the vaccine is rolled out] this year. I think more likely is the early part of next year - in the first few months of next year is the most likely. 

“But we've also bought vaccine ahead of it getting approved from a whole different series of international vaccines as well.” 

The UK has ordered 30 million doses of the vaccine, which is already being manufactured ahead of it gaining approval. 

Of the roughly 200 coronavirus inoculations being developed globally, eight are in the final phase of clinical trials, including the Oxford vaccine which is “right at the front” of global efforts having “been in more people than anyone else”, according to England’s chief scientific adviser Sir Patrick Vallance.

“What we do know already is that many of these vaccines are showing the right immune response," he said during Wednesday’s Downing Street briefing, when Boris Johnson announced the new legally-enforced “rule of six” restrictions. 

“So people who have been vaccinated volunteers who've been vaccinated are generating an immune response to the virus. We don't know how long that will last but the immune response looks good in many cases and it's seen in the elderly as well as others.”

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