After a participant suffered severe neurological symptoms, a big vaccine trial had been halted last week. It was one of the first known obstacles on the road for the highly flaunted vaccine candidate; AstraZeneca has been developing together with the University of Oxford.
On Saturday, AstraZeneca said that they had resumed the phase three trials in the UK only; this is after receiving confirmation from the UK Medicines Health Regulatory Authority that it was safe to do so.
In a blog post, the company said that they could not reveal any medical information, saying only that “standard review process triggered a voluntary pause,” Therefore, they added that they were working with health authorities in different countries to govern when other clinical trials may continue.
Pausing the development of a promising vaccine candidate may be shuddering, mostly during a fatal pandemic. But that is expected, and it is the kind of thing that large-scale clinical trials are for. Researchers are carefully monitoring the patients for any bad reaction to be the drug or treatment during the clinical trials. If ever something wrong comes up, they will pause, investigate, and then keep going when it is safe.
“You take any group of 30,000 people, and you watch them over the course of two or three months, it’s likely somebody is going to have an illness that you didn’t expect,” Francis Collins, head of the National Institutes of Health, stated. “And until you’re sure that it was not connected to the trial, and you need to put it on clinical hold.”
STAT first reported the first hold; it was later found that the break was prompted when a patient in the United Kingdom was hospitalized with severe neurological symptoms. These symptoms were similar to those found in people with transverse myelitis, a kind of irritation of the spinal cord. The patient who is expected to recover got the vaccine as part of the trial, but it doesn’t mean that it has caused the illness.
According to STAT, AstraZeneca head Pascal Soriot said in a call with investors that this was the second clinical hold on trial. The first pause was knowingly caused by a different individual who came down with neurological indications – but in that case, they were identified with multiple sclerosis, something unrelated to the vaccine.
The researchers have to dig into the data to figure out what happened in this new case. The process will take some time; while doing this, other trials are looking for evidence of similar symptoms that could have cropped up during their tests.
This occurrence is regular, the steps of the research process cannot be skipped to achieve a safe and effective vaccine. It is also pretty standard, even trials that have already made it through multiple, smaller testing rounds.
To develop a vaccine against the pandemic, past presumptions and pitfalls must be avoided and focus on the evidence, even if it means taking a break and wait for science to come through.