Coronavirus: AstraZeneca trial illness ‘probably not related’ to vaccine

Illness symptoms in AstraZeneca Covid vaccine trial participants probably weren’t related to the vaccine, Oxford University says.

Symptoms of illness in participants in the AstraZeneca COVID-19 vaccine trials which led to those trials being suspended probably weren’t related to the vaccine, according to Oxford University.

The late stage trials, carried out by AstraZeneca and the University of Oxford, were suspended for safety reviews last week while researchers investigated whether side effects reported by a patient were linked to the vaccine.

The New York Times reported one volunteer in the trial had been diagnosed with transverse myelitis, an inflammatory syndrome affecting the spinal cord.

In an information sheet posted online, Oxford University stated that after independent review, the symptoms “were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine. In each of these cases, after considering the information, the independent reviewers recommended that vaccinations should continue.”

However the university also seemed to suggest that more than one volunteer had shown side effects which it described as “unexplained neurological symptoms.”

“In the current trial we have undertaken safety reviews when volunteers in the trials of ChAdOx1 nCoV-19 developed unexplained neurological symptoms including changed sensation or limb weakness, ” it wrote, after explaining: “Reactions in the nervous system are also extremely rare, but can cause an illness called Guillain-Barré syndrome. This is a condition in which people can develop severe weakness and can be fatal.”

The paper went on to warn that it was not yet known whether the vaccine being trialled could lead to increased disease-related inflammation or to “more severe COVID-19 disease in some cases.”

AstraZeneca declared on Sunday that the trial, one of the most ­advanced among efforts to combat the coronavirus would recommence. It said an independent British review had “concluded its investigations and recommended to the (Medicines Health Regulatory Authority) that trials in the UK are safe to resume”.

It would not disclose information about the patient’s illness for confidentiality reasons but Oxford University said in a statement that it was “expected” that “some participants will become unwell” in large trials such as this one.

The Australian government has signed a deal with Oxford University and AstraZeneca for access to a successful vaccine, with another agreement in place with CSL and the University of Queensland.

Hopes have been high that the vaccine might be one of the first to come on the market, following successful phase 1 and 2 testing.

Its move to Phase 3 testing in recent weeks has involved 30,000 participants around the world. Phase 3 trials in vaccines often involve thousands of participants and can last several years.

Health Minister Greg Hunt said on Sunday there was “genuine hope and optimism” that a COVID-19 vaccine would be available in the first half of next year after the resumption of trials.

“For us the number one is safety, that trumps everything,” Mr Hunt told Sky News. “We have been very cautious and that’s why we were able to look very carefully before choosing our vaccine candidate. We’ll continue to review the evidence.

“But each day I’m quietly becoming more hopeful and more optimistic about the prospect for vaccines for Australians in the first half of 2021, with the earliest available in the first quarter of 2021.”

CSL chief scientific officer ­Andrew Nash last week said the pause in the Oxford University trial showed that all due care was being taken.

In the US, the National Institutes of Health has launched an investigation of the case.

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”