AstraZeneca announced that the COVID-19 vaccine trial has resumed in the United States, including at UW Health and the UW School of Medicine and Public Health, after the FDA and an independent safety review board completed their review of an illness contracted by a trial participant in the United Kingdom.

The trial has been on hold in the U.S. since Sept. 6. This was to allow examination of safety data by independent committees because of a single event of an unexplained illness in one of the participants that occurred in the trial running in the United Kingdom. Pauses such as this are commonplace in clinical trials to determine if the vaccine or the treatment was associated with the onset of the illness.

Upon review of the independent committee’s recommendations, health authorities across the world have confirmed clinical trials are safe to resume. In the U.S., the FDA have reviewed all safety data and concluded it was safe to resume the trial. UW Health officials want the public, including current and future participants, to be assured by the great care taken to protect the public that will ensure 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.

A man is vaccinated
Jeff Pothof, MD, receives a trial vaccine from AstraZeneca prior to the pause. As the clinical trial resumes, UW Health will reach contact study participants to schedule appointments.

“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,” said William Hartman,, the principal investigator for the COVID-19 vaccine AstraZeneca clinical trial and assistant professor of anesthesiology. “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.”

When UW Health announced the clinical trial back 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.

“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 at UW School of Medicine and Public Health. “We are excited to continue this important work and are grateful for the support of the community.”

Nugent, Hartman and Jeff Pothof, MD, chief quality officer at UW Health, are available for interviews. Pothof was the first participant of the vaccine trial at UW.