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The Covid vaccine Australia has invested in has suffered a major setback after researchers discovered a suspected serious adverse reaction in a trial participant.
The vaccine, which is being developed by pharmaceutical giant AstraZeneca and the University of Oxford, is being tested in 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.
The adverse reaction, which AstraZeneca says is an unexplained illness, is believed to have affected only one participant in the UK.
A suspected “serious adverse reaction” means that the participant may require hospitalization. It could result in a life-threatening illness or even death.
Australia has ordered the launch of 84 million doses of the AstraZeneca vaccine next year. The federal government signed a $ 1.7 billion supply and production agreement for the vaccine.
Deputy Medical Director Nick Coatsworth said reports of a major setback in trials need to be investigated.
Dr Coatsworth told Today that the adverse reaction reported in the trials “does not mean that the Oxford vaccine is dead.”
“But it is a serious adverse reaction and must be investigated,” he said.
Dr Coatsworth said it showed that the Oxford vaccine developers were following rigorous safety procedures when reporting the incident.
“The focus on safety is exactly the same and I’m actually getting a lot of reassurance from this first news this morning,” he said. “It in no way eliminates the vaccine completely.”
A spokesperson for AstraZeneca, one of the pioneers in the race for a COVID-19 vaccine, said in a statement that the company’s “standard review process caused a pause in vaccination to allow for review of safety data.”
According to the medical news website STAT, the nature of the adverse reaction and when it happened was also unknown, although the participant is expected to recover.
An AstraZeneca spokesperson said the trial was halted with “great caution.”
He described the pause as “a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials.”
He also said the company is “working to accelerate the review of the single event to minimize any potential impact on the testing schedule.”
Researchers have noticed side effects from the vaccine before, but they have been classified as mild or moderate.
A phase 1/2 study published in July reported that about 60 percent of the 1,000 participants who received the vaccine experienced side effects.
All side effects, including fever, headaches, muscle aches, and injection site reactions, were rated mild or moderate. All reported side effects also decreased over the course of the study.
Trial suspensions are not uncommon, but it is a blow to global hopes that an injection will be ready in the coming months, as the AstraZeneca injection was viewed by many, including the World Health Organization, as the leading candidate for world level.
Researchers had hoped to find out if the vaccine worked and was safe by the end of the year, but now it seems increasingly unlikely.
Market confidence in AstraZeneca took a hit as soon as reports of the trial suspension emerged.
Shares of AstraZeneca plummeted eight percent in after-hours trading.
Norman Swan, a health expert at ABC, said the “adverse reaction” might not be related to the vaccine itself, as many of the thousands of people involved are also taking a placebo.
“If you are studying 17,000 people, someone is going to have a heart attack, someone is going
to get pneumonia, someone is going to break their leg, “he said. “It is necessary to see if it is attributable to the vaccine.
“The only reaction that scares vaccine manufacturers is called: it is an antibody-dependent enhancement reaction. It really is the immune system that overreacts when someone is exposed to the real virus.
“That is what happened with SARS 1. It is quite a recognizable phenomenon.
“If it’s something random like a heart attack, it’s unlikely you need to worry.”
He added that AstraZeneca did the right thing by pausing the trial.
Dr Coatsworth told Sunrise that the Australian government is investing in multiple technologies, multiple candidates for a Covid vaccine.
“We know that not everyone will go to the market,” he told Sunrise. “And that is why we have so many different candidate vaccines, I think more than 160 around the world, that are being tested.”
– more to come
