Final clinical trials for a COVID-19 vaccine under development by Oxford University and AstraZeneca have been paused after one participant in the United Kingdom fell ill.
On Tuesday night, AstraZeneca disclosed that the late-stage studies of the vaccine had been paused while the company investigates whether the participant’s reported side effect is connected with the vaccine.
An AstraZeneca spokeswoman, in a statement, said the pause was part of a standard review process which occurs in trial if there is a “potentially unexplained illness” reported in any trial subject, and that the subject’s illness could also be coincidental.
She said the company is working to expedite the review of the development to minimise any potential impact on the trial timeline.
“As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” the spokeswoman said.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.
“In large trials illnesses will happen by chance but must be independently reviewed to check this carefully.
“We are working to expedite the review of the single event to minimise 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 vaccine, developed by Oxford University, is being tested in thousands of people in Britain and the United States, and in smaller study groups in South America.