{"id":151315,"date":"2020-09-10T22:20:13","date_gmt":"2020-09-10T22:20:13","guid":{"rendered":"https:\/\/www.bnreport.com\/astrazeneca-pausing-coronavirus-vaccine-trial-is-normal-say-scientists\/"},"modified":"2020-09-10T22:20:13","modified_gmt":"2020-09-10T22:20:13","slug":"astrazeneca-pausing-coronavirus-vaccine-trial-is-normal-say-scientists","status":"publish","type":"post","link":"https:\/\/www.bnreport.com\/en\/astrazeneca-pausing-coronavirus-vaccine-trial-is-normal-say-scientists\/","title":{"rendered":"AstraZeneca pausing coronavirus vaccine trial is normal, say scientists"},"content":{"rendered":"

Pausing a late-stage human vaccine trial is normal. Whats not is that the world is watching.<\/p>\n

News broke overnight in Europe from STAT<\/a> that trials of a front-runner coronavirus vaccine developed by AstraZeneca and the University of Oxford had to be paused after one participant reported a negative reaction.<\/p>\n

But some experts who jumped into the fray on Wednesday argued theres no cause for grave concern.<\/p>\n

For one, they noted, these vaccine trials have tens of thousands of participants. Its not uncommon for a participant to report an illness, related or unrelated to the vaccine, at some point.<\/p>\n

The company also hasnt confirmed numerous details about the participants illness or if the person even received the vaccine or a placebo.<\/p>\n

\nCoronavirus vaccines are largely seen as the critical exit strategy, and the world is closely watching their development.\n<\/p><\/blockquote>\n

The New York Times<\/a> reported that the trial participant developed transverse myelitis, an inflammatory illness that affects the spinal cord, citing an anonymous source. This has not been confirmed.<\/p>\n

This was later backed by STAT, which reported that AstraZeneca held a phone call with investors and said that a participant had symptoms similar to transverse myelitis, and the person had received the vaccine.<\/p>\n

The companys Chief Executive Pascal Soriot also reportedly told investors that clinical trials were shut down in July after a participant had neurological symptoms. The participant was later diagnosed with multiple sclerosis unrelated to the vaccine. None of the reporting from STAT has been confirmed.<\/p>\n

Publicly, the head of the U.S. National Institutes of Health (NIH) Francis Collins told a Senate panel on Wednesday that a participant had a \u201cspinal cord problem,\u201d although it was not certain whether this was the same participant that caused the trials to be put on hold.<\/p>\n

If the vaccine is found to have real consequences, \u201call the doses manufactured for that will be thrown away,\u201d Collins said. But putting tests on hold is not unprecedented.<\/p>\n

So far, AstraZeneca has issued reassurances that pausing a trial is a \u201croutine\u201d step in such cases, taken to independently verify the cause of the illness, according to a company statement<\/a>.<\/p>\n

The difference is that there has never been such pressure to create a vaccine so quickly for so many. Coronavirus vaccines are largely seen as the critical exit strategy, and the world is closely watching their development \u2014 without knowing whats a legitimate concern.<\/p>\n

It also doesnt help that these vaccines have become political fodder. This summer, Russian President Vladimir Putin said Russias Sputnik vaccine is ready for use<\/a>, even before large-scale Phase 3 trials had begun. U.S. President Donald Trump said a vaccine could be ready<\/a> before the countrys presidential election in November.<\/p>\n

To allay concerns, drug companies are stressing that these coronavirus vaccines are being held to the highest safety standards.<\/p>\n

Following Trumps comments that a vaccine could be ready by October, for example, nine of the leading vaccine companies pledged Tuesday<\/a> that they wouldnt release their vaccines without regulatory approval based on Phase 3 trial data.<\/p>\n

Alasdair Munro, a clinical research fellow at the Southampton Clinical Research Facility who works on the AstraZeneca trials, listed all the things researchers do to ensure participant safety via a lengthy Twitter thread<\/a> Wednesday: Participants can call an emergency phone number; researchers receive alerts if any participant logs a serious symptom after vaccination; and participants talk with researchers through face-to-face reviews.<\/p>\n

If anything goes wrong \u2014 even a car accident \u2014 researchers alert the trial sponsor within 24 hours, he wrote.<\/p>\n

Phase 3 clinical trials are \u201cinherently difficult,\u201d Jeremy Farrar, head of London-based health research charity the Wellcome Trust, told reporters Wednesday. \u201cThings come up.\u201d<\/p>\n

Ohid Yaqub, a senior lecturer at the University of Sussexs Science Policy Research Unit, said its actually a good thing for the public to see such a \u201croutine event\u201d because they become familiar and trust these procedures.<\/p>\n

And people will need to get used to possible hiccups or legitimaRead More \u2013 Source<\/a>
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politico<\/a><\/h5>\n

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