What prompted the closure of the AstraZeneca vaccine?

A participant in AstraZeneca’s coronavirus vaccine trial triggered a global shutdown of the promising vaccine after she experienced worrisome neurological symptoms.

The woman’s symptoms were consistent with transverse myelitis, a serious spinal inflammatory disorder that can cause bladder problems, muscle weakness, pain and, in the worst case, paralysis.

AstraZeneca CEO Pascal Soriot revealed the woman’s symptoms in a private conference call with investors yesterday, information that was later shared with health news site STAT.

The woman had been participating in phase three of the AstraZeneca coronavirus vaccine trial in the UK when she began experiencing symptoms.

Soriot said that while her diagnosis had not yet been confirmed, she was on the mend and was due to be discharged from the hospital this week.

The woman had been injected with the AstraZeneca vaccine, not a placebo, Soriot added.

This is not the first time that the company’s vaccine trial has been stopped due to a participant’s health.

Soriot confirmed that the clinical trial was stopped in July after another participant experienced neurological symptoms.

However, in further investigation, the participant was diagnosed with multiple sclerosis and was deemed unrelated to the coronavirus vaccine by health authorities.

Soriot told the three private investors on the conference call that the company was taking the vaccine very seriously.

“A vaccine that nobody wants to take is not very helpful,” Soriot said.

Following the call, AstraZeneca issued a statement saying it was bringing in independent experts to discuss when the company can resume clinical trials “so that we can continue our work at the earliest opportunity to provide this vaccine widely, equitably and without profit during this pandemic. “.

Australian health authorities have warned against pinning all hopes on a single vaccine.

Dr Brian McNamee, president of CSL, the company responsible for producing vaccines in Australia, said the vaccine could face a long delay, if it arrives at all.

“If they had asked us, we would have told them that drug development is a very complex thing,” Dr. McNamee told the Herald Sun.

“We can’t trust a vaccine. I think the treatments are improving, but we have to learn to live with Covid. We have to manage it.”

However, Dr. McNamee said the company was “cautiously optimistic” but warned of “risks.”

“That’s why at CSL we have two vaccines that we could make because the likelihood that both will work is not high,” he told the publication.

It is not uncommon to place clinical suspensions in vaccine trials, as pharmaceutical companies work to ensure that treatment is as safe as possible.

“Having clinical control, as was imposed on AstraZeneca as of yesterday, due to a single serious adverse event is nothing unprecedented,” said Francis Collins, director of the US National Institutes of Health, at a Senate panel yesterday.

“This certainly happens in any large-scale trial where there are tens of thousands of people who invest in participating. Some of them may get sick and you always have to try to find out: is it from the vaccine or were they to get that disease anyway? ? “

Prime Minister Scott Morrison signed a letter of intent with AstraZeneca in August in the hope that the vaccine investigated by the University of Oxford will be ready early next year.

The Letter of Intent covers the development, production and distribution of vaccines in Australia with a formal agreement that includes the price of the vaccine to taxpayers.

“Today is a day of hope, and Australia needs hope, the world needs hope, when it comes to this coronavirus,” Morrison said last month.

“But … there is no guarantee that this vaccine, or any other, will be successful, so we continue our discussions with many parties around the world while simultaneously supporting our own researchers to find a vaccine.”

The AstraZeneca 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.

The vaccine is being developed by a team of scientists from the Oxford Vaccine Group (Department of Pediatrics) and the Jenner Institute at the University of Oxford in the UK.

The group developed the vaccine by taking a SARS-CoV-2 spike protein and injecting it into an adenovirus that causes the common cold.

The spike protein is expected to trigger an immune response when injected into humans and the body will quickly recognize the pathogen if it is exposed again and responds.

Adenovirus has yet to be used in an approved vaccine, but it has been tested in other experimental vaccines, including an Ebola vaccine.