TParticipating in triggering a global closure of the AstraZeneca Phra 3 Covid-19 vaccine test is a woman in the United Kingdom who has experienced neurological symptoms associated with a rare but severe inflammatory brain disease called transverse myelitis , said the chief executive of the drug manufacturer 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 is likely to be released from the hospital on Wednesday, Soriot said.
The AstraZeneca data surveillance board and safety components clinical trials have confirmed that the participant was injected with the company̵7;s Covid-19 vaccine and not a placebo, Soriot said in a conference call. , set up by investment bank JP Morgan.
Soriot also confirmed that the clinical trial was stopped once before in July after a participant experienced neurological symptoms. On further examination, that participant was diagnosed with multiple sclerosis, which was considered unrelated to the Covid-19 vaccine treatment, he said.
The new revelations made by Soriot were heard by three investors who participated in the call and shared with STAT. An AstraZeneca spokesperson did not respond to an email request for further comment.
An investor on the call said Soriot’s comments were intended to ensure investors that the company took the vaccine safety event seriously, and to reverse any damage to the company’s stock price. “A vaccine that anyone wants to take is not very useful,” Soriot said.
So far, AstraZeneca’s public statements on the pause have been sparse with details. For example, the company did not confirm to the public that this was the second time it had stopped its tests to investigate health events among participants.
On Wednesday, the company issued a statement, linked to Soriot, saying that AstraZeneca will be guided by a committee of independent experts in determining when to hold the trial “so that we can continue our work as soon as possible. this vaccine. wide, even and without income during this pandemic. “
AstraZeneca’s is the first Phase 3 Covid-19 vaccine test known to be postponed. Such handling is not uncommon, and it is not yet clear how long AstraZeneca will last.
“To have a clinical handling, as put on AstraZeneca until yesterday, due to a single serious adverse event is never possible,” Francis Collins, director of the National Institutes of Health, told a Senate panel on Wednesday. . “It certainly happens in any large-scale trial where you have thousands of people invested to participate, some of them can get sick and you always try to find out: Is it because of the vaccine, or are they going to get that disease ? “
AstraZeneca just started its Phase 3 test in the US in late August. The US trial is currently taking place at 62 sites nationwide, according to clinicaltrials.gov, a government registry, although some have not yet started enrolling participants. The Phase 3 trial in the US aims to enroll about 30,000 participants at 80 sites nationwide, according to a release last week from the NIH. Phase 2/3 trials previously began 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 caused by Covid-19. Adenovirus is designed to stimulate the immune system to produce a protective response 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 involving inflammation of the spinal cord that can cause muscle weakness, paralysis, pain and bladder problems. In rare cases, vaccines have triggered cases of transverse myelitis; although it can also be caused by viral infections.
Helen Branswell and Lev Facher contributed to the reporting.