Coronavirus: University of Oxford vaccine trial suspended after participant falls ill

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Reuters

Final clinical trials of a coronavirus vaccine, developed by AstraZeneca and the University of Oxford, have been put on hold after a participant had an adverse reaction in the UK.

AstraZeneca described it as a ‘routine’ break from ‘unexplained illness’.

The results of vaccine trials are closely monitored around the world.

The AstraZeneca-Oxford University vaccine is seen as a serious competitor among dozens in development around the world.

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There was high hope that the vaccine could be one of the first to hit the market, after successful phase 1 and 2 testing.

Its move to phase 3 testing in recent weeks has involved some 30,000 participants in the United States as well as the United Kingdom, Brazil and South Africa. Phase 3 vaccine trials often involve thousands of participants and can last for several years.

What did the developers say?

All international trial sites have now been put on hiatus as an independent investigation examines safety data before regulators decide whether the trial can restart, reports BBC medical editor Fergus Walsh.

“In large trials, diseases will occur by chance, but must be independently examined to verify this carefully,” said a spokesperson for the University of Oxford.

This is the second time that the Oxford coronavirus vaccine trial has been suspended, our correspondent notes. Such events are common in major trials and occur any time a volunteer is admitted to hospital when the cause of their illness is not immediately apparent.

It is believed that trials could resume in a few days.

Stat News, the health website that first broke the story, said details of the British participant’s adverse reaction were not immediately known, but cited a source as saying they should recover .

Where are we in the search for a vaccine?

US President Donald Trump has said he wants a vaccine to be available in the US ahead of the Nov. 3 election, but his comments raised concerns that politics could be prioritized over security 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 commitment” to uphold scientific and ethical standards in the search for a vaccine.

AstraZeneca is one of nine companies that have agreed to seek regulatory approval only after vaccines have passed through three phases of clinical study.

Industry giants Johnson & Johnson, BioNTech, GlaxoSmithKline, Pfizer, Merk, Moderna, Sanofi and Novavax are the other signatories.

They pledged to “always make the safety and well-being of those vaccinated our top priority”.

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

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

Similar sentiments were shared by Thomas Cueni, managing director of the International Federation of Pharmaceutical Manufacturers. The industrial body represents the companies that have signed the commitment.

Despite this, China and Russia have started inoculating some key workers with vaccines developed in the country. All are still listed by the WHO as undergoing clinical trials.

Meanwhile, the US national regulator, the Food and Drug Administration (FDA), has suggested that coronavirus vaccines could be approved before completing a third phase of clinical trials.

Last week, it also emerged that the U.S. Centers for Disease Control and Prevention had urged states to consider waiving certain requirements in order to be ready to distribute a potential vaccine by November 1 – two days before the presidential election of November 3.

Although President Trump has hinted that a vaccine may be available ahead of the election, his Democratic rival Joe Biden has expressed skepticism that Mr. Trump will listen to scientists and implement a transparent process.

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