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.
Stat News, the health website which first broke the story, said details of the UK participant’s adverse reaction were not immediately known, but quoted a source as saying they were expected to recover.
Decision on restarting trial could be days away
Analysis by Fergus Walsh, BBC Medical Editor
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.
Where are we in the search for a vaccine?
US President Donald Trump has said he wants a vaccine available in the US before 3 November’s election, but his comments have raised fears that politics may be prioritised over safety in the rush for a vaccine.
On Tuesday, a group of nine Covid-19 vaccine developers sought to reassure the public by announcing a “historic pledge” to uphold scientific and ethical standards in the search for a vaccine.
AstraZeneca is among the nine firms who signed up to the pledge to only apply for regulatory approval after vaccines have gone through three phases of clinical study.