Oxford COVID-19 Vaccine Trial on Hold after 'Unexplained Illness'

Grant Boone
September 10, 2020

The UK drugmaker's vaccine candidate, developed with the University of Oxford, was in late-stage trials and had previously been described as the most advanced coronavirus vaccine candidate by the WHO.

The World Health Organization (WHO) says almost 180 vaccine candidates are being tested around the world but none has yet completed clinical trials. "The trial is assessing efficacy and safety of the potential vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants", AstraZeneca wrote in a September 3 news release.

Brazil, which has the third worst outbreak of the novel coronavirus in the world after the United States and India, has become a testing ground for at least two vaccine candidates.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated", AstraZeneca shared in a prepared statement.

On Tuesday, AstraZeneca and its partner, the University of Oxford, confirmed it had stopped giving patients the experimental shot after a person in the United Kingdom who was participating in one of their studies got sick, triggering a review of safety data.

It could be nothing, or it could be the end of this vaccine.

It is not clear if the participant's diagnosis is directly connected to the experimental vaccine.

And even unrelated health events in vaccine participants - such as a broken bone - are regarded as adverse reactions that can lead to a pause.

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The vaccine - known as AZD1222 - uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. And it's suspected they have transverse myelitis - an inflammatory syndrome that affects the spinal cord. The U.S. trial is now taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants.

Commenting on the recent reports on AstraZeneca halting the trials in the UK, SII said in a statement: "We can " t comment much on the UK trials, but they have been paused for further review and they hope to restart soon".

Now as for transverse myelitis, it can be serious.

The health secretary, Matt Hancock, also stressed that clinical trials are often halted, telling Sky News that it is "a standard process in clinical trials whenever they find something that they need to investigate". All of the reported side effects subsided during the course of the study.

The Oxford vaccine includes people 70 years and older, which naturally increases the risk of temporally associated adverse results.

A file photo of Prime Minister Scott Morrison, right, at the AstraZenaca factory in Sydney after he announced the Federal Government's vaccine deal.

Some scientists are saying the pause is not unexpected, and in fact shows that the clinical trial protocol is operating as it should. So it is possible that this unexplained illness is just a coincidence and happened by chance.

Earlier this summer, the AstraZeneca/Oxford trial was paused when a patient developed neurological symptoms. "You want to make sure it was related to the vaccine, especially if it happened a short period of time after the vaccine begins". For now, his participation is on hold, but Walters says he plans to continue "in the name of science", adding that the trial is "something positive to do in the face of something that rendered everyone rather helpless".

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