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Madison, Wis. — A clinical trial of an investigational COVID-19 vaccine has resumed in the United States after the FDA and an independent safety review board completed their review of a trial participant in the United Kingdom who became ill.
UW received approval on Friday, Oct. 23 to reopen its clinical trial of AstraZeneca's investigational COVID-19 vaccine. The trial should officially resume next week.
Thirty-six participants received the first of two shots before the study was paused on Sept. 6, and they continued to receive study-related checkups and blood draws throughout the pause period. Those participants will now have the option to receive their second dose. No additional participants were enrolled during the pause.
Enrollment is expected to resume over the next several weeks, and the UW study team will begin contacting individuals who had previously expressed interest in participating in the trial. Participants at all study locations will need to complete a revised informed consent form that includes updated safety information.
UW Health and the UW School of Medicine and Public Health want the public to know that the safety of all clinical trials, including vaccine trials, is paramount.
"We are thrilled to be back. These extensive reviews show that experts have the best interest of the public at heart," said Dr. William Hartman, principal investigator for the trial and an assistant professor of anesthesiology. "A single patient out of 20,000 worldwide developed an unexplained illness and the trial was halted. They took the time to figure out the safety. The system works."
Update: This study is no longer enrolling new participants.