AstraZeneca has paused a phase three trial of its potential COVID-19 vaccine
The nature of the case and when it happened were not detailed, although the participant is expected to recover, according to Stat News, which first reported the news.
In a statement, AstraZeneca said an independent committee would now review its safety data.
AstraZeneca, one of the co-signers of the open pledge, told a United States outlet that trials of their vaccine candidate were temporarily suspended after a patient fell seriously ill.
The vaccine, which AstraZeneca is developing with researchers from the University of Oxford, has been viewed as one of the leading candidates.
AstraZeneca has put clinical development of its COVID-19 vaccine on hold in response to an adverse event, sparking a reassessment of the race to bring a coronavirus prophylactic to market.
Eric Topol, a cardiologist and clinical-trials expert at the Scripps Research Translational Institute in San Diego, said such pauses in large studies are "not uncommon at all".
Dr. Jeff Pothoff, chief quality officer of University of Wisconsin Health, where one of the trials is being conducted, received the potential vaccine Wednesday, CBS affiliate WISC-TV reports.
"In large trials illnesses will happen by chance but must be independently reviewed to check this carefully", the spokesperson said.
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The companies said they would "uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines".
"With the information that I have got at the moment, I am not anxious about it", Australia's Deputy Chief Medical Officer Nick Coatsworth told Sky News, adding the hold on trials does not mean the vaccine "is off the table". AstraZeneca has agreed to furnish BARDA with 300 million doses of the vaccine.
Moderna said in an emailed statement it was "not aware of any impact" to its ongoing COVID-19 vaccine study at this time.
AstraZeneca's stock fell 8% in the wake of the news.
Russian Federation registered the world's first vaccine against coronavirus, dubbed Sputnik V, on 11 August, after it underwent clinical trials at two separate institutions: the Burdenko Main Military Clinical Hospital and the Sechenov First Moscow State Medical University. "1 "potential" side effect vs 35,000 COVID patients hospitalized in US today".
Loncar added: "The Astra trial participant may end up being nothing and unrelated to the trial, but at least it's a reminder of how risky and unpredictable biology can be". The signatories include CEOs of AstraZeneca, BioNTech SE (NASDAQ: BNTX), Pfizer Inc (NYSE: PFE), Moderna Inc (NASDAQ: MRNA), Johnson & Johnson (NYSE: JNJ), and GlaxoSmithKline Plc (NYSE: GSK). Participants had been randomized to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control.
"It's not rare that clinical trials get suspended as various factors interact", health ministry official Yoon Tae-ho told a briefing.
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