Coronavirus Vaccine: AstraZeneca halts trials of its COVID-19 vaccine after ‘unexplained’ illness in volunteer
Rohit Kumar, Editor: The late-stage trials of the COVID-19 vaccine candidate which is being developed by UK pharma firm AstraZeneca alongside Oxford University have been put on hold after a volunteer developed an ‘unexplained’ illness.
AstraZeneca said that it has voluntarily paused the trials to investigate whether a recipient’s “potentially unexplained” illness is a side effect of the shot.
In a statement issued on Tuesday evening, the company said its “standard review process triggered a pause to vaccination to allow the review of safety data”. An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the US and other countries.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow the review of safety data by an independent committee,” a spokesperson 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.”
The company further said that the volunteers sometimes develop illness in large trials and it should be reviewed independently. “We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” the spokesperson added.
However, the company did not reveal the location of the volunteer or the nature and the severity of the illness developed in the volunteer.
AstraZeneca is one of nine companies currently in late-stage Phase 3 trials for their vaccine candidates. The vaccine, called AZD1222, uses a weakened version of a common cold-causing adenovirus that has been engineered to code for the spike protein that the novel coronavirus uses to invade cells.
Late last month, AstraZeneca began recruiting 30,000 people in the US for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.