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The discontinuation of the development of the Covid-19 vaccine from the University of Oxford due to an adverse reaction in a trial participant has prompted fears of a delay in finding a solution to the coronavirus restrictions.
A spokesman for AstraZeneca, the company that works with the academic team to produce the vaccine, said the voluntary hiatus is “routine.”
While governments around the world have endorsed this specific vaccine, the details of the “potentially unexplained illness” in one of the trial participants are unclear.
Here’s what we know and what it could mean for the Covid-19 vaccine race.
What happened to the Oxford University vaccine trial?
On Tuesday, British-Swedish pharmaceutical company AstraZeneca confirmed that one of the volunteers in a trial of the vaccine in the United Kingdom had developed an unexplained illness.
The company said it took the step to voluntarily stop the trial.
All trials of this vaccine, which have so far included at least 17,000 people in the UK, Brazil and South Africa, have been stopped.
The vaccine had previously generated a strong immune response and is currently in phase three trials, the final step before a vaccine is approved.
Details of the unexplained illness have not been released, but according to a New York Times report, a UK program volunteer had received a diagnosis of transverse myelitis, an inflammation in the spinal cord. However, AstraZeneca has not commented on this and there is no evidence that patients with transverse myelitis include the patient who caused the study to be discontinued. The report was careful to note that the time of diagnosis and whether it was directly related to the AstraZeneca vaccine is still unknown.
What will this mean for the vaccine? How long will it be on pause?
While all trials are on hold, an independent committee will review the virus safety data to determine if the reported illness in the trial participant can be attributed to the vaccine, or if it was an unrelated illness that they developed.
Professor Robert Booy, a vaccination professor at the University of Sydney, told The Guardian that research into the disease, if it is shown to be isolated and not related to the vaccine, could mean that vaccine trials will be suspended. for just a week and as long as a month.
Booy thinks the interruption “is more likely due to being very careful” rather than being a problem with the vaccine.
Is this common? Have vaccine trials been paused before but then approved?
Yes, according to AstraZeneca, which has called this a “routine action”.
The BBC reported that this is the second time that this particular vaccine has been stopped since trials began in April.
More generally, medical experts also say it is common to stop trials, and Booy believes the pause is actually a “promising” sign of rigor in the development process.
He said that this particular incident has only been widely reported because “the eyes of the world are on this vaccine,” and that the discontinuation of the trial was probably due to being very careful. “
“This could have just been a high fever and it turns out they have appendicitis,” he said. “My bet would be that they find something in this participant that is not causal [from the vaccine]. It will take them one to two weeks to find out, and then they will probably restart the test in a month. “
What if the review determines that it is an unrelated condition?
Trials will resume. Booy believes this will be the most likely outcome and believes the vaccine can still be delivered in early 2021.
What if the review finds that the patient’s illness was caused by the vaccine?
If more incidents of the adverse reaction are discovered in other trial participants, or if the reaction is shown to be caused by the vaccine, it is unlikely that the vaccine will be the first to be implemented.
Is this vaccine our only hope?
No. The Oxford vaccine is one of six vaccines in phase three trials (the last step before approval) around the world.
While the UK and Australian governments have committed to administering 100 million and 33.8 million doses of the vaccine, respectively, there are other options.
The UK government has also signed a 90 million dose deal for another vaccine, developed between BioNTech, Pfizer and Valneva.
On Monday, the Australian government, in announcing its agreement for the Oxford vaccine, also included an agreement with the company CSL for 51 million doses of a vaccine from the University of Queensland, currently in preclinical trials.
Earlier Tuesday, the CEOs of nine companies developing different vaccines, including AstraZeneca, as well as BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, pledged to make a “joint commitment to uphold the integrity from the scientific process as they work towards potential global regulatory filings and approvals of the first Covid-19 vaccines. “
Booy noted that the Oxford vaccine uses a modified chimpanzee adenovirus, while other vaccines being tested rely on different proteins.
He noted that the American company Moderna’s vaccine, which is based on mRNA, was also in phase three of the trials and was another promising option.
What are the chances of a vaccine now?
Booy believes that the Oxford vaccine should not be ruled out based on this patient’s reaction.
He said that if the disease is related to the vaccine, he is still optimistic that one of the six vaccines currently in phase three will be approved and rolled out early next year.
“We have never had so many smart people working in such large numbers as we have had with these vaccines.”
