On Friday, the biopharmaceutical company AstraZeneca announced they would resume COVID-19 vaccine trials in the United States, including at UW Health and the UW School of Medicine and Public Health.
On Sept. 6, phase three trials of the AstraZeneca COVID-19 vaccine were put on hold in the U.S. due to an unknown spinal cord issue experienced by a female trial volunteer in the United Kingdom.
The FDA and an independent safety review board finished a review of the participant’s undiagnosable illness and relative safety of the trial, ultimately leading to the Oct. 23 UW Health announcement detailing the trial’s resumption in Madison, Wis.
“Halting clinical trials to review is very common but they do not often have a global spotlight on them like this,” said Betsy Nugent, MSPH, CCRP, chief clinical research officer and director of clinical trials development and accreditation at the UW School of Medicine and Public Health. “We are excited to continue this important work and are grateful for the support of the community.”
William Hartman, Assistant Professor of Anesthesiology and AstraZeneca COVID-19 vaccine clinical trial Principal Investigator, emphasized the importance of safety in the developing stages of a vaccine.
“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. The system works. A single patient out of 20,000 worldwide developed an unexplained illness and the trial was halted,” Hartman said. “This should give the public confidence that the FDA and the independent safety review board have the best interest of the public at heart. They want to be confident that the vaccines are safe for everyone. This isn't a race to produce the fastest vaccine, these are clinical trials to discover the right vaccine.”
The UW site is one of 100 clinical sites across the country that chose to participate in the vaccine trial. University Hospital sought to enroll approximately 1,600 people in the following eight weeks according to an Aug. 31 news release through the UW School of Medicine and Public Health.
During the clinical trial, volunteer participants were randomly assigned to one of two groups: a group that received two injections of a placebo and a group that received two injections of AZD1222 — the investigational vaccine. Two-thirds of the trial subjects received the investigational vaccine.
“UW Health and SMPH are proud to be at the forefront of working toward identifying safe, effective solutions to this global pandemic,” Nugent says upon the return of the clinical trial. “Our entire team has been working diligently for months to bring this important clinical trial to our state, and now Wisconsinites have an opportunity to be part of solving the crisis.”