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AstraZeneca Puts COVID-19 Vaccine Trial on Hold After a Serious Adverse Reaction

AstraZeneca Plc said on Tuesday that after an unexplained disease in a study participant it has paused a late-stage trial of one of the leading candidates for the COVID-19 vaccine.
“Our standard review process was triggered and we voluntarily paused vaccination to allow the review of safety data by an independent committee,” company spokeswoman Michele Meixell said in an emailed statement.
The study is testing a COVID-19 vaccine being developed by researchers from AstraZeneca and the University of Oxford at various sites, including the UK, where the disease was reported.
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According to Stat News, which first reported the trial was halted due to a “suspected serious adverse reaction,” the nature of the case and when it happened were not detailed though the participant is expected to recover.
The U.S. Food and Drug Administration defines that as an adverse event in which evidence suggests that the drug being tested may be related.

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AstraZeneca puts leading COVID-19 vaccine trial on hold|Getty Image

The trial’s suspension has affected other AstraZeneca vaccine trials-as well as clinical trials being carried out by other vaccine makers looking for signs of similar reactions, Stat said. The U.S. National Health Institutes, which provides funding for the AstraZeneca trial, have declined to comment.
AstraZeneca’s statement said that “in large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.”
AstraZeneca’s shares fell more than 8 percent in U.S. trading after-hours, while rival vaccine developers’ shares rose. Moderna Inc. increased more than 4% and Pfizer Inc. increased less than 1%.
Moderna said it was “not aware of any impact” on its ongoing study of the COVID-19 vaccine at this time, in an emailed statement.
Nine leading developers of U.S. and European vaccines pledged to uphold scientific safety and efficacy standards for their experimental vaccines on Tuesday despite the urgency of containing the coronavirus pandemic.
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The companies, including AstraZeneca, Moderna, and Pfizer issued what they called a “historic pledge,” following an increase in concern that safety standards might slip in the face of political pressure to rush out a vaccine.
The firms said they would “maintain the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines”
Johnson & Johnson, Merck & Co, GlaxoSmithKline, Novavax Inc, Sanofi, and BioNTech were the other signatories.

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[…] vaccine by AstraZeneca and Oxford University resumed this month in Japan after being placed on hold over a British volunteer’s illness that is believed to have been caused by the […]

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[…] Read Also: AstraZeneca Puts COVID-19 Vaccine Trial on Hold After a Serious Adverse Reaction […]

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