A trial of the coronavirus vaccine tipped to be the front runner in the fight against Covid-19 has been put on hold after a UK volunteer suffered a suspected serious adverse reaction.
AstraZeneca Plc – which is working alongside the University of Oxford – has confirmed it had had to pause development of the vaccine “to allow review of safety data”.
While the pause raises serious safety concerns, Health Secretary Matt Hancock claims that it’s ‘not necessarily a setback.’
Speaking this morning, Mr Hancock said that AstraZeneca’s decision to pause its vaccine trial was a challenge but would not necessarily set back efforts to develop a vaccine.
“It is obviously a challenge to this particular vaccine trial,” Hancock said on Sky News when asked about the pause in the trial. “It’s not actually the first time this has happened to the Oxford vaccine.”
Asked whether it would set back the vaccine development process, he said: “Not necessarily, it depends on what they find when they do the investigation.”
The nature of the adverse reaction or when it occurred are not known but the participant is reportedly expected to recover.
An AstraZeneca spokesperson described the pause as a “routine action” which must happen whenever a “potentially unexplained illness” occurs in one of its trials.
They said during the investigation it is crucial it “maintain[s]the integrity of the trials”, adding the company is working to “expedite the review of the single event” in order to “minimise any potential impact” on the trial’s timeline.
Stat News reports a source told reporters researchers were told the hold has been imposed as “an abundance of caution” while another said it has also impacted other vaccine trials being undertaken by the company and other manufacturers.
AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial of the nine front runners known to have been put on hold.
It only began its late stage trial in the US in late August, with 62 sites earmarked – while others were started in the UK, Brazil and South Africa.