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article imageUnexplained illness in volunteer puts vaccine trial on hold

By Karen Graham     Sep 9, 2020 in Health
A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
Putting a vaccine trial on hold is a standard precaution meant to ensure that a thorough review of the safety data is conducted. "As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data," the company said in a statement sent to CNN.
This development also means a U.S. study that started last week, with a goal of recruiting 30,000 volunteers, will also be put on hold, according to the Wall Street Journal.
AstraZeneca is also conducting studies in Latin America, Asia, Europe, and Africa for the Oxford vaccine, so named because the vaccine was developed at Oxford University.
"In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully," the statement went on to say. "We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials."
In a follow-up statement from AstraZeneca, they confirmed they had initiated the pause. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter, per Stat News.
This alleged "adverse reaction" has not been confirmed.
More about Astrazeneca, coronavirus, vaccine trials, unexplained illness, suspected serious adverse reaction
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