- The AstraZeneca and Oxford University vaccine trials have been put on hold
- A ‘serious adverse event,’ a possible reaction to the shot was reported in the UK
- Adverse event ‘serious’ if it requires hospitalization, or if it is life-threatening
- The individual is expected to recover, but little else is known about their identity
- It is not clear if regulators, AstraZeneca or Oxford called for the trial hold
- The Oxford University was dubbed the best hope for a vaccine by the WHO
- Had been hoped the vaccine could be rolled out in the ‘first few months’ of 2021
Phase 3 trials for the coronavirus vaccine being developed by Oxford University and AstraZeneca have been placed on a hold after a ‘serious adverse event’ was reported in a participant in the UK.
Serious adverse events are suspected reactions to vaccines or drugs that require hospitalization, are life-threateningly or deadly.
It’s unclear what the exact nature of the reaction was, but a person familiar with the matter told Stat News that the person is expected to recover.
Trial holds are not uncommon, but it is a blow to worldwide hopes for a shot to be ready in the coming months, as the AstraZeneca shot was considered by many – including the World Health Organization – to be the leading candidate worldwide.
The UK’s Health Secretary Matt Hancock said earlier this week he hoped it could be rolled out in the ‘first few months’ of 2021.
And Australia, for example, has spent $1.7 billion (US $1.24 billion) to secure access to a supply of 84 million COVID-19 vaccines, should the clinical trial be a success.
Trials for AstraZeneca’s shot are underway in the US, UK, Australia, Brazil (pictured) and other nations. Phase 3 testing will now be paused while safety data is reviewed
Development of the AstraZeneca vaccine and eight others in phase 3 trials is being closely watched in the hopes they can stem the coronavirus pandemic that has killed more than 894,000 people worldwide, including nearly 190,000 Americans, and cost tens of millions their jobs.
It comes after vaccine developers – including AstraZeneca – pledged not to cut corners on safety and efficacy testing, despite US President Trump’s urgent push for the Food and Drug Administration (FDA) to give emergency approval to a vaccine ahead of the November 3 election.
‘As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,’ an AstraZeneca spokesperson told DailyMail.com.
‘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 trials, illnesses will happen by chance but must be independently reviewed to check this carefully. We are 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’s candidate vaccine, known as AZD1222, is in phase 3 trials – the final stage before safety and efficacy data can be submitted to regulators for approval – at dozens of sites across the US, and around the world.
Along with Pfizer, and Moderna, AstraZeneca and its partner Oxford University had hoped to know whether the shot worked and was safe by year-end.
Mr Hancock said on Monday the UK’s ‘best-case scenario’ was to get the vaccine to the most-vulnerable patients within months, a timeframe that now appears less likely to be met.
‘We have got 30 million doses already contracted with AstraZeneca,’ he said on UK radio station LBC.
‘In fact they are starting to manufacture those doses already, ahead of approval, so that should approval come through – and it’s still not certain but it is looking up – should that approval come through then we are ready to roll out.
‘The best-case scenario is that happens this year. I think more likely is the early part of next year – in the first few months of next year is the most likely.
‘But we’ve also bought vaccine ahead of it getting approved from a whole different series of international vaccines as well.’
More than 50,000 people worldwide had been taking part in ‘phase 3’ studies to see whether the Oxford jab can actually prevent people getting infected with Covid-19.