AstraZeneca said Sept. 9 it has taken a "voluntary pause" of its phase 3 COVID-19 vaccine trial after an adverse reaction in a patient in the U.K.
The drugmaker, which has been conducting its vaccine trials with the University of Oxford in England, said the delay is routine when there is a potentially unexplained illness in a trial.
"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 minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials," the drugmaker stated.
The nature of the adverse reaction and when it happened is unclear, as is the length of the trial delay.
Pascal Soriot, AstraZeneca's CEO, said: "At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts. We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic."
HealthPartners, a Bloomington, Minn.-based health system, said it has suspended recruiting participants in its trial testing AstraZeneca's vaccine since the adverse effect, according to the Star Tribune.
"The trial sponsor has let us know that it is having a review and evaluation of the trial this week, so we are pausing enrollment for this to occur," said HealthPartners spokesman David Martinson. "Upon completion of the evaluation, we will be able to reschedule patients."
The adverse effect has also halted trials at the University of Kansas Medical Center and Children's Mercy, both in Kansas City, as well as at the University of Wisconsin Hospital in Madison.