[ad_1]
The report describes in detail how the volunteer, a previously healthy 37-year-old British woman, “experienced transverse myelitis” after receiving the second dose of the vaccine, after which she was hospitalized on September 5.
Four days later, “AstraZeneca” denied media reports that the volunteer suffered from this rare neurological condition that causes inflammation of the spinal cord.
The document, called an “initial report,” describes how the study participant had trouble walking, hand weakness and pain, and a host of other symptoms.
AstraZeneca’s announcement last week announced a voluntary suspension of the trial because one of the participants was diagnosed with an “unexplained illness.” On Saturday, the interrogation continued in Britain, while in the United States it was still on hiatus.
Some scientists say the drug company was not fully open.
A company spokesperson says they, as trial sponsors, “cannot disclose medical information.”
The pharmaceutical giant said it was “committed to the safety of the participants and the highest standards of conduct in the trials,” and that it was “only a matter of time before” testing continued in the United States.
Two weeks after receiving the second dose of the vaccine, a woman, living in Britain, was confirmed with transverse myelitis, with symptoms including difficulty walking and pain and weakness, according to the safety report.
The volunteer received the first dose of the coronavirus vaccine in early June and then felt fine. She received the second dose in late August.
The study participant “tripped, didn’t fall” on September 2 while running. The report notes that she had no obvious cervical spine injuries.
The next day, she had symptoms including difficulty walking, pain and weakness in her hands, pain and decreased sensation in her body, headache, and decreased ability to use her hands. She was hospitalized on September 5.
The AstraZeneca report twice mentions that the woman was diagnosed with “confirmed” transverse myelitis. It is also said that the neurologist who was consulted in her case “suggested that the symptoms were in line with the diagnosis of transverse myelitis.”
The report was sent to the doctors who conduct the vaccine test. The cover page of the report, submitted by an AstraZeneca contracted provider, described his condition as “confirmed” transverse myelitis, and the doctor asked the doctors to report to their institutional review board or local ethics committee if necessary.
The report notes that the woman visited a neurologist, who claimed that the patient had not reported significant neurological symptoms or illnesses in the past. The second point states that there is “limited information on the subject’s relevant medical history.”
According to the report, no other similar cases were diagnosed among the other study volunteers. The neurologist noticed that the study volunteer began to feel better.
“The relief of his symptoms happened quite quickly, considering that his illness started only four days ago. His symptoms were improving. The strength and dexterity in his hands were improving,” the report says.
AstraZeneca later denied it was myelitis.
“Reports that claim to be based on comments previously made by our CEO, who state that we have confirmed that a participant in our clinical trial suffered from transverse myelitis, are inaccurate. He stated that there is no definitive diagnosis and that there will not be. it doesn’t even establish an independent board, “said a Sept. 9 statement.
When asked about the volunteer’s status, “AstraZeneca” sent CNN to the information list for participants, updated on September 11 on the Oxford website.
The list refers to study volunteers who “developed unexplained neurological symptoms, including changes in sensation or weakness in the limbs.”
The document goes on to say that “after an independent review, these diseases were considered not related to the vaccine or there was insufficient evidence to say with certainty that the diseases were related or not related to the vaccine.” He added that “be careful to monitor the affected people and other participants.”
It is not clear why the Oxford patient list refers to “unexplained neurological symptoms” and does not mention transverse myelitis.
Kurir.rs/New York Times / CNN
delivery courier
Author: delivery courier
[ad_2]
