UW Health gears up for resumption of AstraZeneca’s COVID-19 vaccine trial
MADISON, Wis. (WKBT) — AstraZeneca’s resumption of its COVID-19 vaccine trial puts health officials at UW Health and the UW School of Medicine and Public Health back in action in the testing phase.
The U.S. Food and Drug Administration and an independent safety review board completed their review of an illness that a trial participant in the United Kingdom had contracted.
The trial, which AstraZeneca said Friday now is ready to resume, had been on hold in the United States since Sept. 6 to allow independent committees to examine safety data.
Such pauses are commonplace in clinical trials to determine whether the vaccine or the treatment contributed to the illness.
UW Health officials assured the public, including current and future participants, that they take great care to ensure that the vaccine is safe before it is approved for use.
UW Health plans to contact study participants to provide the latest information and to set up appointments to continue the trial.
“The U.S. has some of the most stringent regulatory rules in the world and has been undergoing an extensive investigation to ensure the safety of the vaccine,” said Dr. William Hartman, the principal investigator for the COVID-19 vaccine AstraZeneca clinical trial and assistant professor of anesthesiology.
“The system works,” Hartman said. “A single patient out of 20,000 worldwide developed an unexplained illness, and the trial was halted. This should give the public confidence that the FDA and the independent safety review board have the best interest of the public at heart. … This isn’t a race to produce the fastest vaccine. These are clinical trials to discover the right vaccine.”
When UW Health announced the clinical trial in September, nearly 10,000 people reached out to be part of the study, the most of any AstraZeneca trial site in the United States.
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