Pascal Soriot, managing director of AstraZeneca.
Simon Dawson | Bloomberg | Getty Images
The participant who triggered a worldwide shutdown of AstraZeneca's Phase 3 Covid-19 vaccine trials was a woman in the UK who was experiencing neurological symptoms related to a rare but serious inflammatory spinal disease called transverse myelitis, the executive director of the said Drug maker, Pascal Soriot during a private conference call with investors Wednesday morning.
The woman's diagnosis has not yet been confirmed, but she is improving and will likely be discharged from the hospital today, Soriot said.
The panel tasked with overseeing the data and safety components of AstraZeneca's clinical trials confirmed that the participant was injected with the company's Covid-19 vaccine rather than a placebo, Soriot said on the conference call set up by investment bank JP Morgan.
Soriot also confirmed that the clinical trial was canceled once in July after a participant developed neurological symptoms. Upon further examination, this participant was diagnosed with multiple sclerosis, which was considered unrelated to Covid-19 vaccine treatment.
The new information from Soriot was heard by three investors involved in the solicitation and passed on to STAT. An AstraZeneca spokesperson failed to respond to an email request for further comments.
An investor said Soriot's comments should reassure investors that the company is serious about the potential vaccine safety event and undo any damage to the company's stock price. "A vaccine that nobody wants to take is not very useful," said Soriot.
So far, AstraZeneca's public statements about the break have been sparsely detailed. For example, the company has not publicly confirmed that this is the second time its studies have been abandoned to investigate health events among participants.
On Wednesday, the company issued a statement attributed to Soriot that said AstraZeneca would be led by a committee of independent experts in deciding when to lift the trial's suspension "so that we can resume our work at the earliest opportunity to resolve this Provide vaccine. " broadly just and for no profit during this pandemic. "
AstraZeneca & # 39; s is the first known Phase 3 Covid-19 vaccine study to be suspended. Holds like this are not uncommon and it is not yet clear how long AstraZenecas will last.
"It is by no means unprecedented to have a clinical impact as identified yesterday at AstraZeneca from a single serious adverse event," Francis Collins, director of the National Institutes of Health, told a Senate committee on Wednesday. "This certainly happens in any large-scale study that has tens of thousands of people invested in participating. Some of them can get sick and you always have to try to find out: Is it because of the vaccine or were they going to get this disease anyway?"
AstraZeneca only started its phase 3 study in the US in late August. The U.S. clinical trial is currently underway in 62 locations across the country, according to Clinicaltrials.gov, a government registry, although some have not yet started enrolling participants. The US Phase 3 trial aims to enroll approximately 30,000 participants in 80 locations across the country. This came from a statement from the National Institutes of Health last week. Phase 2/3 studies were previously started in the UK, Brazil and South Africa.
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. The adenovirus is supposed to induce the immune system to produce a protective reaction against SARS-2. The platform was not used in an approved vaccine, but was tested in experimental vaccines against other viruses, including the Ebola virus.
Transverse myelitis is a serious condition in which the spinal cord is inflamed and can cause muscle weakness, paralysis, pain, and bladder problems. Rarely, vaccines have caused cases of transverse myelitis; although it can also be caused by viral infections.