COVID-19 VACCINE TRIAL PARTICIPANT HAD SERIOUS NEUROLOGICAL SYMPTOMS, BUT might be DISCHARGED TODAY, ASTRAZENECA CEO SAYS
The participant who triggered a worldwide shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a lady in the uk who experienced neurological symptoms according to a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a personal call with investors on Wednesday morning.
The woman’s diagnosis has not been confirmed yet, but she is improving and can likely be discharged from the hospital as early as Wednesday, Soriot said.
The board tasked with overseeing the info and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the call , which was found out by the investment bank J.P. Morgan.
Soriot also confirmed that the clinical test was halted once previously in July after a participant experienced neurological symptoms. Upon further examination, that participant was diagnosed with MS , deemed to be unrelated to the Covid-19 vaccine treatment, he said.
The new disclosures made by Soriot were heard by three investors participating on the decision and were shared with STAT. An AstraZeneca spokesperson didn't answer an email request for further comment.
One investor on the decision said Soriot’s comments were intended to reassure investors that the corporate was taking the possible vaccine safety event seriously, and to reverse any damage to the company’s stock price. “A vaccine that nobody wants to take is not very useful,” said Soriot.
To date, AstraZeneca’s public statements on the pause are sparse with details. as an example , the corporate has not publicly confirmed that this is often the second time its trials are stopped to research health events among participants.
On Wednesday, the corporate issued a press release , attributed to Soriot, saying AstraZeneca would be guided by a committee of independent experts in determining when to lift the hold on the trial “so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”
AstraZeneca’s is that the first Phase 3 Covid-19 vaccine trial known to possess been placed on hold. Such holds aren't uncommon, and it’s not clear yet how long AstraZeneca’s will last.
“To have a clinical hold, as has been placed on AstraZeneca as of yesterday, because of a single serious adverse event is not at all unprecedented,” Francis Collins, the director of the National Institutes of Health, told a Senate panel on Wednesday. “This certainly happens in any large-scale trial where you have tens of thousands of people invested in taking part, some of them may get ill and you always have to try to figure out: Is that because of the vaccine, or were they going to get that illness anyway?”
AstraZeneca only began its Phase 3 trial within the U.S. in late August. The U.S. trial is currently happening at 62 sites across the country, consistent with clinicaltrials.gov, a government registry, though some haven't yet started enrolling participants. The Phase 3 trial within the U.S. aims to enroll about 30,000 participants at 80 sites across the country, consistent with a release last week from the NIH. Phase 2/3 trials were previously started within the U.K., Brazil, and South Africa .
The vaccine — referred to as AZD1222 — uses an adenovirus that carries a gene for one among the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is meant to induce the system to get a protective response against SARS-2. The platform has not been utilized in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus .
Transverse myelitis may be a serious condition involving inflammation of the medulla spinalis which will cause muscle weakness, paralysis, pain and bladder problems. In rare instances, vaccines have triggered cases of transverse myelitis; although it also can be caused by viral infections.
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