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Oxford University Vaccine Trials "Paused" after One of Participants Becomes Ill


The world's most awaited AstraZeneca-Oxford University vaccine's final trials are paused after one of its volunteers found ill during the trial.

 Pharmaceutical company AstraZeneca said Tuesday it had "voluntarily paused" a randomized clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness.

The company, which is developing the drug alongside the University of Oxford, is a frontrunner in the global race for a Covid-19 vaccine.

Holds during clinical trials are not uncommon, but this is thought to be the first time it has happened for a Covid-19 vaccine trial. But, AstraZeneca described it as a "routine" pause in the case of "an unexplained illness".

"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," a spokesperson said.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

It added that in large trials, illnesses will sometimes happen by chance but must be reviewed independently.

"We are working to expedite the review of the single event to minimise any potential impact on the trial timeline," the spokesperson added.

It was not immediately clear where the patient was, or the nature and severity of their illness.

Its move to Phase 3 testing in recent weeks has involved some 30,000 participants in the US as well as in the UK, Brazil and South Africa. Phase 3 trials in vaccines often involve thousands of participants and can last several years.

US President Donald Trump has said he wants a vaccine available in the US before 3 November's election, but his comments have raised fears that politics may be prioritised over safety in the rush for a vaccine.

On Tuesday, a group of nine Covid-19 vaccine developers sought to reassure the public by announcing a "historic pledge" to uphold scientific and ethical standards in the search for a vaccine.

AstraZeneca is one of nine companies currently in late-stage Phase 3 trials for their vaccine candidates.

In the US, the company began enrolling 30,000 volunteers across dozens of sites on August 31.

The vaccine, called AZD1222, uses a weakened version of a common cold causing adenovirus that has been engineered to code for the spike protein that the novel coronavirus uses to invade cells.

After vaccination, this protein is produced inside the human body, which primes the immune system to attack the coronavirus if the person is later infected.

The World Health Organization (WHO) says nearly 180 vaccine candidates are being tested around the world but none has yet completed clinical trials.

The organisation has said it does not expect a vaccine to meet its efficacy and safety guidelines in order to be approved this year because of the time it takes to test them safely.

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