- European biotech giant AstraZeneca has paused an advanced COVID-19 vaccine clinical trial after a suspected serious adverse reaction in a participant
- It’s not yet known what the reaction was and when the patient is expected to recover, or even what exactly caused the reaction
- AstraZeneca said in a statement the pause was routine action as the unexplained illness is reviewed
- The news comes just two days after the Australian Government ordered some 33.8 million doses of the vaccine for roll-out in early 2021
- AstraZeneca and eight other global biotech giants pledged yesterday to make safety their top priority in vaccine development
- AstraZeneca’s U.S. shares fell over eight per cent in the extended session Tuesday, while CSL’s shares are currently down just over 2.5 per cent
European biotech giant AstraZeneca has paused an advanced COVID-19 vaccine clinical trial after a suspected serious adverse reaction in a participant.
The news comes just two days after the Australian Government ordered some 33.8 million doses of the AstraZeneca vaccine, which is being developed in partnership with Oxford University, for roll-out in early 2021.
It’s not yet known exactly what the adverse reaction was and when the trial participant is expected to recover, or what actually caused the reaction.
Does this mean the vaccine is unsafe? Not quite.
In a statement first obtained by Stat News, AstraZeneca said the pause was a routine action which has to happen whenever this is an unexplained illness in a major clinical trial.
“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully”, AstraZeneca said.
“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline.”
In a follow-up statement, the company stressed that the trial pause was completely voluntary. As such, it could be the case that illness had nothing to do with the vaccine but was caused by something else entirely — hence the review of safety data.
Moreover, the adverse effects have so far been recorded in just one patient of the thousands already enrolled.
As part of Monday’s Federal Government deal, Australia’s own biotech giant, CSL, agreed to make around 30 million doses of AstraZeneca and Oxford’s vaccine for release in early 2021.
On top of this, the government agreed to buy 51 million doses of CSL’s vaccine formula if clinical trials proved successful.
Biotechs combine
Today’s announcement of the paused trial comes just a day after nine CEOs from the world’s biggest biotech bodies pledged to make safety and well-being the top priority of COVID-19 vaccine development.
The likes of AstraZeneca, Johnson & Johnson, GlaxoSmithKline, and Pfizer pledged to uphold scientific safety and efficacy standards for their vaccines regardless of how urgently they need to be developed.
“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the pledge stated.
Together, the nine biotechs have developed over 70 vaccines to help eradicate some of the world’s most complex and deadly public health threats.
Following news of the trial delay, AstraZeneca’s U.S. stock has dropped per cent after hours, down more than eight per cent in the extended session Tuesday.
On the ASX, CSL shares have suffered a 2.61 per cent blow by midday AEST on the back of AstraZeneca’s news.