AstraZeneca halts COVID-19 vaccine trial after ‘unexplained illness’

AstraZeneca (AZN.L) has paused human trials of a COVID-19 vaccine it has developed in partnership with the University of Oxford.

StatNews, a specialist medical website in the US, first reported on Tuesday evening that AstraZeneca had paused a large Phase 3 trial of AZD1222, an experimental vaccine previously known as ChAdOx1 nCoV-19.

A spokesperson for AstraZeneca confirmed to Yahoo Finance UK the trial had been halted after the discovery of an “unexplained illness” in one patient.

“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 spokesperson said.

“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.”

The independent review is expected to take days and if the illness is found to be unconnected to the vaccine then the trials will be restarted.

Shares in AstraZeneca fell over 2.5% in early trade in London, before paring back some losses.

The vaccine has been developed in conjunction with the University of Oxford and is one of the most closely-watched potential COVID-19 vaccines in development around the world. Europe had already signed a deal with AstraZeneca to produce 400 million doses of the vaccine in anticipation of successful trials, while the US had ordered 300 million doses.

30,000 people across Brazil, the UK, US, and South Africa are currently taking part in trials of the drug.

AstraZeneca’s spokesperson didn’t give details about what specifically triggered the pause. StatNews reported that it was triggered by “a suspected serious adverse reaction in a participant in the United Kingdom.”

Dr. Adam Barker and Dr. Tara Raveendran, healthcare analysts at stockbroker Shore Capital, cited reports suggesting the adverse affect could be transverse myelitis (TM), which is an inflammation of the spinal cord.

Dr. Barker and Dr. Raveendran said more details were needed on the pause of the trial to draw any firm conclusions.

“Adverse events aren’t uncommon in clinical studies and it could certainly be nothing to do with the vaccine (most aren’t), but the very sensible (if not only) thing to do in such a circumstance is to temporarily suspend the study and investigate what has happened,” the pair wrote in a note on Wednesday morning.

The vaccine trial had been due to conclude in November but Dr Barker and Dr Raveendran said this pause would likely delay that timeline.

The spokesperson for AstraZeneca said: “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.”

 

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