The clinical trial of AstraZeneca’s high-level coronavirus vaccine has been paused after a UK participant experienced a “potentially unexplained illness,” according to the company statement.
While the participant had a suspected “serious” adverse reaction, it was possible that the disease was not caused by the vaccine, according to the statement that first reported it. Stat.
The statement said: “As part of the ongoing global randomized and controlled trials of the Oxford Coronavirus vaccine, our standard review process has led to the suspension of vaccination to allow review of safety data.”
“This is a routine procedure that should occur whenever there is a potential unexplained disease in an experiment, while investigating it, ensuring that the integrity of the trials is maintained.”
Citing two people with knowledge of the issue, researchers were asked to delay the trial out of “a great deal of caution” while the finding had an impact on other trials by AstraZeneca and other vaccine manufacturers, according to Stat.
The United Kingdom is among the countries that will sign up to purchase millions of doses of AstraZeneca if they develop a successful vaccine, which is currently undergoing Phase 3 trials in dozens of locations across the UK, the US, Brazil and South Africa.
The AstraZeneca vaccine was developed in partnership with the University of Oxford and is backed by the US government’s Warp Speed Operation to accelerate development with $ 1.2 billion (£ 905 million) in aid to secure 300 million doses for a successful candidate.
Nine vaccine makers issued a statement on Tuesday pledging that they will not submit vaccines for approval until safety and efficacy are demonstrated, with AstraZeneca being the first major report of a serious problem from the few coronavirus trials in Phase 3.
An AstraZeneca spokesperson said the disease was a “one event” and that they are committed to the participants’ safety and experiences.
“In large trials, diseases will happen by chance, but they need to be independently reviewed to check this carefully,” the spokesman said.
“We are working to speed up individual event review to minimize any potential impact on the trial schedule.”