Clinical rials of a Covid-19 vaccine under development by AstraZeneca and Oxford University have been put on hold after a participant had an adverse reaction in the UK.
AstraZeneca issued a statement on Tuesday night saying the late-stage studies of the vaccine had been paused while the company investigates whether the patient’s reported side effect is connected with the vaccine.
AstraZeneca did not reveal any information about the patient’s condition other than to describe it as “a potentially unexplained illness”.
News site Stat first reported the pause in testing and said the possible side effect occurred in a testing volunteer in Britain, who was expected to recover.
The vaccine, developed by Oxford University, is being tested in thousands of people in Britain and the US, and in smaller study groups in Brazil and South America.
READ MORE: Coronavirus: Oxford vaccine 'appears safe' and can train immune system
An AstraZeneca spokeswoman 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.
“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 in a statement.
“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.”
No details about the patient suffering the potential side effect, or the nature of the reaction, were given.
Temporary holds of large medical studies are not uncommon, and looking into any unexpected reactions is a mandatory part of safety testing. It was not immediately clear how long AstraZeneca’s pause would last.
Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc and the other by Pfizer and Germany’s BioNTech.
Stats reported a total of nine vaccine candidates in late stage, or phase 3, trials, with AstraZeneca’s the first trial known to have been put on hold.
Despite some figures, such as US President Donald Trump, insisting a vaccine will be ready in a matter of months, Oxford University says a vaccine might not be ready before 2022.
The university stressed clinical trials had to be conducted with the utmost care.
“It takes time to develop safe and effective vaccines – usually five to ten years on average. Despite promising reports about potential coronavirus vaccines being developed worldwide, it could still take an estimated 12-18 months to develop one,” a document on the university’s website, dated August 25, reads.
“It is essential that clinical trials are conducted with great care to ensure the safety of the participants and to fully establish the safety profile of the new products.
“Safety is overseen closely during the trials both by the national regulator with a requirement of safety reporting placed on investigators throughout the trial, and inspections of the trial processes and procedures by the regulator, and an independent safety monitoring committee who reviews safety actively during the conduct of the clinical trial.
“When an application for use of the vaccine is made to a regulator, they will fully assess the safety and efficacy data from the trials and use that to inform on their decision about potential use.”
Why are you making commenting on The Herald only available to subscribers?
It should have been a safe space for informed debate, somewhere for readers to discuss issues around the biggest stories of the day, but all too often the below the line comments on most websites have become bogged down by off-topic discussions and abuse.
heraldscotland.com is tackling this problem by allowing only subscribers to comment.
We are doing this to improve the experience for our loyal readers and we believe it will reduce the ability of trolls and troublemakers, who occasionally find their way onto our site, to abuse our journalists and readers. We also hope it will help the comments section fulfil its promise as a part of Scotland's conversation with itself.
We are lucky at The Herald. We are read by an informed, educated readership who can add their knowledge and insights to our stories.
That is invaluable.
We are making the subscriber-only change to support our valued readers, who tell us they don't want the site cluttered up with irrelevant comments, untruths and abuse.
In the past, the journalist’s job was to collect and distribute information to the audience. Technology means that readers can shape a discussion. We look forward to hearing from you on heraldscotland.com
Comments & Moderation
Readers’ comments: You are personally liable for the content of any comments you upload to this website, so please act responsibly. We do not pre-moderate or monitor readers’ comments appearing on our websites, but we do post-moderate in response to complaints we receive or otherwise when a potential problem comes to our attention. You can make a complaint by using the ‘report this post’ link . We may then apply our discretion under the user terms to amend or delete comments.
Post moderation is undertaken full-time 9am-6pm on weekdays, and on a part-time basis outwith those hours.
Read the rules here