AstraZeneca says independent committee will decide when trials of Oxford University’s Covid-19 vaccine can resume
AstraZeneca has confirmed an independent committee will confirm when its trials of a potential Covid-19 vaccine can resume, after they were paused because of an individual falling ill.
One person in the UK has an “unexplained illness” after taking part in the phase III trial of the vaccine, which was developed by Oxford University .
Standard procedure in such cases is to halt trials while an investigation confirms that there is no safety issue for those involved.
Cambridge-based Astrazeneca said “a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness”.
A similar pause happened earlier in the year.
The company added: “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 clinical trials, illnesses will happen by chance and must be independently reviewed. AstraZeneca is 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.”
AstraZeneca CEO Pascal Soriot said: “At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts.
“We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”
As the Cambridge Independent reported, Mr Soriot and the CEOs of eight other biopharmaceutical companies signed a pledge yesterday to put the safety of participants first in Covid-19 vaccine development, and to maintain the scientific integrity of the process.
The pledge came after international safety concerns over Russia’s decision to approve a Covid-19 vaccine prior to phase III trials.
No details about the individual suffering the illness have been confirmed.
The New York Times has reported that the patient had been diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord, often sparked by viral infections.
Wellcome Trust director Professor Sir Jeremy Farrar, a member of the Sage committee advising the government, told BBC Radio 4’s Today programme that unexplained illnesses during such trial can be quite common but must be taken seriously.
He said it was inevitable that some of the 30,000 to 40,000 people given the vaccine will have illnesses unrelated to it.
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