Final clinical trials for a coronavirus vaccine, developed by AstraZeneca and Oxford University, have been put on hold after a participant had a suspected adverse reaction in the UK.
AstraZeneca described it as a “routine” pause in the case of “an unexplained illness”. The outcome of vaccine trials is being closely watched around the world.
The AstraZeneca-Oxford University vaccine is seen as a strong contender among dozens being developed globally.
Hopes have been high that the vaccine might be one of the first to come on the market, following successful phase 1 and 2 testing.
Its move to Phase 3 testing in recent weeks has involved some 30,000 participants in the US as well as in the UK, Brazil and South Africa. Phase 3 trials in vaccines often involve thousands of participants and can last several years.
The New York Times is reporting a volunteer in the UK trial has been diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and can be caused by viral infections.
However, the cause of the illness has not been confirmed and an independent investigation will now work out if it was related to the vaccine.
At first glance this may seem alarming. A vaccine trial – and not just any vaccine, but one receiving massive global attention – is put on hold due to a suspected serious adverse reaction. But such events are not unheard of. Indeed the Oxford team describe it as “routine”. Any time a volunteer is admitted to hospital and the cause of their illness is not immediately apparent it triggers a study to be put on hold.
This is actually the second time it has happened with the Oxford University/AstraZeneca coronavirus vaccine trial since the first volunteers were immunised in April. An Oxford University spokesperson said: “In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.”
A final decision on restarting the trial will be taken by the medical regulator the MHRA, which could take only days. But until then all international vaccination sites, in the UK, Brazil, South Africa and the USA are on hold.
The Oxford University team believe this process illustrates that they are committed to the safety of their volunteers and the highest standards of conduct in their studies.
