ANN ARBOR, MI — A COVID-19 vaccine produced by pharmaceutical company AstraZeneca has been voluntarily paused as one patient experienced an unexplained illness in the United Kingdom Phase 3 trial.
The University of Michigan and Michigan Medicine is scheduled to test the vaccine in Phase 3, the university previously announced. Michigan Medicine spokeswoman Mary Masson said once AstraZeneca’s evaluation is complete, patients will be scheduled for the trial.
University of Michigan to conduct clinical trial of AstraZeneca coronavirus vaccine
The voluntary pause was a routine action “which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” AstraZeneca officials said in a news release.
“In large clinical trials, illnesses will happen by chance and must be independently reviewed. AstraZeneca is working to expedite the review of the single event to minimise any potential impact on the trial timeline,” the release states. “We are committed to the safety of our participants and the highest standards of conduct in our trials.”
AstraZeneca, headquartered in the United Kingdom, is one of several companies testing a COVID-19 vaccines through a partnership with the U.S. Department of Health and Human Services' plan to find and bring to market a vaccine on an accelerated timeline, called “Operation Warp Speed.”
Oxford University led the first phases of the trial. Researchers tested the vaccine in more than 1,000 people earlier this year, according to a July AstraZeneca news release. The vaccine uses a non-replicating chimpanzee adenovirus to deliver a spike protein from the virus that causes COVID-19, officially known as SARS-CoV-2, to induce an immune response.
UM previously said it will recruit “hundreds” of participants until the trial is full. Interested trial participants should visit Michigan Medicine’s website or email AZVaccineTrial@med.umich.edu. Participants must be at least 18 years old, in good or stable health and have not been previously diagnosed with COVID-19.
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