Pharmaceutical company AstraZeneca said Tuesday it “voluntarily paused” a randomized clinical trial of its coronavirus vaccine, what it called a routine action after a volunteer developed an unexplained disease.
The company, which is jointly developing the drug with the University of Oxford, is a pioneer in the global race for a Covid-19 vaccine.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard screening process has been triggered and we have voluntarily suspended vaccination to allow an independent committee to review the safety data,” said a spokesman.
“This is a routine action that must be performed whenever any of the studies has a potentially unexplained disease while it is being investigated to ensure the integrity of the studies is maintained.”
It added that in large studies, diseases sometimes occur randomly but need to be independently verified.
“We are working to speed up the review of the individual event to minimize any impact on the test schedule,” added the spokesman.
It was not immediately clear where the patient was or what type and severity his illness was.
Holds during clinical trials are not uncommon, but this is believed to be the first time a Covid-19 vaccine study has been conducted.
AstraZeneca is one of nine companies currently in Phase 3 trials for their vaccine candidates.
In the US, the company began enrolling 30,000 volunteers in dozen of locations on August 31.
The vaccine, called AZD1222, uses a weakened version of a common cold that causes an adenovirus engineered to encode the spike protein that the novel coronavirus uses to enter cells.
After vaccination, this protein is produced in the human body, which causes the immune system to attack the coronavirus if the person later becomes infected.
(Except for the headline, this story was not edited by GossipMantri staff and published from a syndicated feed.)