Covid vaccine trial stopped after side effect was reported in UK patient

Trials of a Covid-19 vaccine in development by AstraZeneca and the University of Oxford have been suspended due to a reported side effect in a patient in the UK.

AstraZeneca released a statement Tuesday night saying that studies on the latest stage of the vaccine have been halted while the company investigates whether the patient’s reported side effect is related to the vaccine.

AstraZeneca did not disclose any information about the patient’s condition other than to describe it as “a potentially unexplained illness.”

Health Secretary Matt Hancock said the Oxford vaccine trial pause is not necessarily a setback and that he has already overcome one of those delays.

He told Sky News: “Obviously, it is a challenge for this particular vaccine.

“This is not actually the first time that this has happened to the Oxford vaccine and it is a standard process in clinical trials.”

When asked if it’s a setback, Hancock said: “Not necessarily, it depends on what they find when they do the research.

“There was a hiatus in early summer and that was resolved without a hitch.”

News site Stat first reported the pause in testing, saying the possible side effect occurred in a test volunteer in Britain, who was expected to recover.

AstraZeneca said testing has been stopped while it investigates ‘a potentially unexplained disease’ associated with its vaccine trials (Simon Dawson / PA) “>

The vaccine, developed by the University of Oxford, is being tested in thousands of people in Britain and the United States, and in smaller study groups in Brazil and South America.

An AstraZeneca spokeswoman said the pause is part of a standard review process that occurs at trial if there is a “potentially unexplained illness” reported in any trial subject, and that the subject’s illness could also be a coincidence.

“As part of the ongoing global randomized controlled trials of the Oxford coronavirus vaccine, our standard review process was activated and we voluntarily stopped vaccination to allow for review of safety data by an independent committee,” he said the spokeswoman in a statement.

In large trials, illnesses will happen by chance, but they need to be independently reviewed to verify this carefully.

“This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials.

“In large trials, diseases will happen by chance, but they need to be independently reviewed to check this carefully.

“We are working to expedite the review of a single event to minimize any potential impact on the trial schedule. We are committed to the safety of our participants and to the highest standards of conduct in our trials. “

No details were provided about the patient suffering from the possible side effect or the nature of the reaction.

Temporary withholdings from large medical studies are not uncommon, and looking for unexpected reactions is a mandatory part of safety testing. It was not immediately clear how long the AstraZeneca hiatus would last.

Two other vaccines are in huge end-stage trials in the United States, one made by Moderna Inc and the other by Pfizer and Germany’s BioNTech.

The University of Oxford said that an effective vaccine could still be between 12 and 18 months (University of Oxford / PA) “>

Stats reported a total of nine candidate vaccines in late stage or phase 3 trials, the first trial of AstraZeneca known to have been discontinued.

Despite some figures, such as US President Donald Trump, insisting that the vaccine will be ready in a matter of months, Oxford University has said the vaccine may not be ready before 2022.

The university stressed that clinical trials must be conducted with the utmost care.

“It takes time to develop safe and effective vaccines, generally five to ten years on average. Despite promising reports of potential coronavirus vaccines being developed around the world, it could still take 12 to 18 months to develop one, ”says a document on the university’s website, dated August 25. .

“It is essential that clinical trials are conducted very carefully to ensure the safety of participants and to fully establish the safety profile of new products.

“Safety is closely supervised during trials both by the national regulator with a requirement for safety reports placed on investigators throughout the trial, as well as by inspections of trial processes and procedures by the regulator, and a committee independent safety monitoring system that actively reviews safety during the clinical trial.

“When an application for the use of the vaccine is submitted to a regulator, they will fully evaluate the safety and efficacy data from the trials and use it to inform their decision on potential use.”