The coronavirus vaccine Australia has invested in has been dealt a major setback after researchers uncovered a suspected serious adverse reaction in a trial participant.
The vaccine, being developed by pharmaceutical giant AstraZeneca and the University of Oxford, is being tested at dozens of sites around the world.
The stage 3 trial – the final stage before safety and efficacy data can be submitted to regulators for approval – has tens of thousands of participants.
But the adverse reaction, which AstraZeneca says is an unexplained illness, is believed to have affected a single participant in the UK.
A suspected “serious adverse reaction” means the participant may require hospitalisation. It could result in a life-threatening illness or even death.
Australia has ordered 30 million doses of the AstraZeneca vaccine to be rolled out next year. The Federal Government has signed off on a $1.7 billion supply and production agreement for the vaccine.
Deputy chief medical officer Nick Coatsworth said reports of a major setback in trials needed to be investigated.
Dr Coatsworth told Today the reported adverse reaction in trials did “not mean that the Oxford vaccine is dead”.
“But it is a serious adverse reaction, and it needs to be investigated,” he said.
Dr Coatsworth said it showed the Oxford vaccine developers were following rigorous safety procedures in reporting the incident.
“The focus on safety is exactly the same and I’m actually taking a lot of reassurance out of these early breaking stories this morning,” he said. “It by no means puts that vaccine completely off the table.”
A spokesman for AstraZeneca, a frontrunner in the race for a COVID-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”
According to medical news website STAT, the nature of the adverse reaction and when it happened were also not known, though the participant is expected to recover.
An AstraZeneca spokesman said the trial pause was done out an “an abundance of caution”.
He described the pause as “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”.
He also said that the company is “working to expedite the review of the single event to minimise any potential impact on the trial timeline”.
Researchers have noticed side effects from the vaccine before, but they have been listed as mild or moderate.
A Phase 1/2 study published in July reported that about 60 per cent of 1000 participants given the vaccine experienced side effects.
All of the side effects, which included fever, headaches, muscle pain and injection site reactions, were deemed mild or moderate. All of the side effects reported also subsided during the course of the study.
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 Organisation (WHO) – to be the leading candidate worldwide.
Researchers had hoped to know whether the vaccine worked and was safe by year-end, but that now looks increasingly unlikely.
Just two days ago the Government locked in 84.8 million vaccines at a cost of $1.7 billion, hoping they would be available as early as January 2021.
“There are no guarantees that these vaccines will prove successful, however the agreement puts Australia at the top of the queue if our medical experts give the vaccines the green light,” PM Scott Morrison said this week.
Market confidence in AstraZeneca took a hit as soon as reports of the trial hold emerged.
Shares for AstraZeneca plummeted by eight per cent in after-hours trading.
ABC health expert Norman Swan said the “adverse reaction” could have been unrelated to the vaccine itself as many of the thousands of people taking part are also taking a placebo.
“If you’re studying 17,000 people, someone is going to get a heart attack, someone is going
to get pneumonia, somebody is going to break a leg,” he said. “You need to see if it’s attributable to the vaccine.
“The one reaction that scares the vaccine makers is called – it’s an antibody dependent enhancement reaction. It’s really the immune system overreacting when someone gets exposed to the real virus.
“That’s what happened with SARS 1. That’s a fairly recognisable phenomena.
“If it’s something random like a heart attack, it’s unlikely to be anything to be worried about.”
He added that AstraZeneca has done the right thing by pausing the trial.
Dr Coatsworth told Sunrise the Australian Government is investing in multiple technologies and multiple candidates for a COVID vaccine.
“We know not all of them will go to market,” he told Sunrise. “And that’s why we have got so many different vaccines candidates, I believe over 160 around the world, that are being tested.”
As the race for a vaccine continues internationally, AstraZeneca along with eight other major players have pledged to “uphold the integrity of the scientific process”.
It comes amid concern US President Donald Trump will pressure regulators to approve a vaccine ahead of the presidential election in November.
“We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” said the CEOs of the companies in a statement.
The statement was signed by AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.
– more to come