Anglo-Swedish pharma giant has voluntarily paused global late-stage trials of the investigational Covid-19 vaccine it is developing with the University of Oxford, AZD1222.
The decision was made because of the unexplained illness of a trial participant and the need to allow an independent data monitoring committee to review the safety data. The committee will determine if the illness is directly linked with the Covid-19 vaccine.
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By GlobalDataThe nature of the participant鈥檚 adverse reaction has not been disclosed, however the has reported that the trial聽 volunteer has been diagnosed with an inflammatory condition called transverse myelitis. AstraZeneca is yet to confirm if this is the case.
It is believed that the patient in question was involved in the UK arm of the trial. AstraZeneca鈥檚 Covid-19 vaccine is also currently involved in Phase III studies in the US, Brazil and South Africa.
In a ,聽AstraZeneca explained: 鈥淭his is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials.鈥� The pause will enable the company to ensure it can 鈥渕aintain the integrity of the trial鈥�.
鈥淚n large trials illnesses will happen by chance, but must be independently reviewed to check this carefully,鈥� the company added in the statement.
The statement also noted that AstraZeneca is 鈥渨orking to expedite the review of the single event to minimise any potential impact on the trial timeline鈥�. There were hopes that AstraZeneca鈥檚 vaccine could be approved by January 2021 and multiple countries 鈥� most notably the UK, Australia, Brazil and the US 鈥� have signed supply deals for this vaccine candidate.
Once the independent data monitoring committee has reviewed the data, according to the medical editor Fergus Walsh, it will communicate its findings with UK healthcare regulator the Medicines and Healthcare products Regulatory Agency (MHRA), which will make the decision on whether to lift the suspension globally. This decision could potentially come within days.
In a statement, AstraZeneca CEO Pascal Soriot that this decision is linked to the company鈥檚 commitment 鈥渢o 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.”
The decision to pause the trial is in tune with a published late yesterday by nine Covid-19 manufacturers, including AstraZeneca, in which they publicly committed themselves to prioritise developing and studying Covid-19 vaccine candidates 鈥渋n accordance with high ethical standards and sound scientific principles鈥�.
Responses from scientists and politicians
There is general agreement that pausing the study is good practice and a routine part of vaccine clinical trials.
UK public health foundation Wellcome Trust鈥檚 head of vaccines Charlie Weller wrote in a published on Twitter: 鈥淰accines are among the most rigorously tested and monitored products in society and the Covid-19 vaccines should be no different. It is critical to quickly understand whether the illness has any relationship to the vaccine or the placebo and to share data openly.鈥�
British Society of Immunology chief executive Dr Doug Brown agreed with this sentiment. In a published , Brown said: 鈥淏ecause safety is so critical, vaccine trials are incredibly complex and each vaccine goes through many stages of testing both in the lab and in clinical trials.
鈥淲hat we are seeing with the news that the AstraZeneca鈥揙xford University coronavirus vaccine trial has been paused due to ill health in one participant is one of these safety procedures kicking in.
鈥淭his type of pause to a vaccine trial to investigate an unexplained illness is not an uncommon event and in fact it’s exactly what we should all want to see the vaccine researchers doing to ensure the safety of any potential vaccine above everything else.鈥�
In an interview with LBC radio and reported by the , UK Secretary of State for Health and Social Care Matt Hancock stated he was not overly concerned about AstraZeneca鈥檚 decision.
鈥淭his is a normal part of a vaccine development that, when you find a problem, the system is paused while you investigate that particular problem,鈥� Hancock said. 鈥淲hat it underlines is that we won鈥檛 bring forward a vaccine unless it is safe, no matter how enthusiastic I am for a vaccine.鈥�
鈥淭his is a pause, not a stop, so I am hopeful [AstraZeneca] will be able to resume, but only if it is safe to do so,鈥� Hancock added.
