AstraZeneca has paused global trials, including large late-stage trials of its experimental coronavirus vaccine after an unexpected illness in study participants.
The vaccine has been widely seen as one of the leading global candidates against the coronavirus. However, according to health news site STAT, which broke the story earlier today, the vaccine’s Phase 3 trial was put on hold after a “suspected serious adverse reaction” to the drug in one participant in the UK.
AstraZeneca said it voluntarily paused trials to allow a review of safety data by an independent committee and was working to expedite the review of the single event to minimize any potential impact on the trial timeline.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials,” the company said in an emailed statement.
“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.”
The suspension of the trial has impacted other AstraZeneca vaccine trials – as well as clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.
The U.S. National Institutes of Health, which is providing funding for AstraZeneca’s trial, declined to comment.
AstraZeneca’s statement said that “in large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.”
As many as 50,000 people were reportedly taking part in trials for the vaccine candidate, which is just one of about 160 such experimental drugs currently being tested to prevent coronavirus infection.
Trials of the vaccine, called AZD1222, are underway at different stages in Britain, the United States, Brazil, South Africa, and India. Trials are also planned in Japan and Russia.