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Oxford vaccine: What were the symptoms that the 37-year-old volunteer experienced | WORLD



An internal safety report from the pharmaceutical company AstraZeneca highlights the neurological disease that one of the participants experiences in the clinical trial of the coronavirus vaccine.

The report, published by CNN, describes in detail how the study volunteer, a previously healthy 37-year-old woman, “experienced confirmed transverse myelitis” after receiving the second dose of the vaccine and was in hospital on September 5.

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; the tests was diagnosed with transverse myelitis

Four days later, AstraZeneca rejected media reports about the participant and the rare neurological condition in which the spinal cord becomes inflamed. The document, which is described as the “initial report”, describes how the participant in the study experienced gait problems, weakness and pain in the arms and other symptoms. The internal safety report is dated to September 10 and September 11 was sent to physicians conducting the clinical trials of the study.

Discontinuation of clinical trials of the vaccine due to voluntary illness

Last week, AstraZeneca announced the study’s inexplicable disease “volunteer, saying it had stopped testing the vaccine worldwide. On Saturday, clinical trials continued in the UK, but are not currently conducted in the US.

Because humans are closely monitoring the development of a number of vaccines, hoping to end the deadly coronavirus pandemic – with more than 30 million cases – some researchers say AstraZeneca’s messages about the patient’s condition were not entirely transparent. However, a company spokesman said they “could not disclose medical information.”

Pharmaceutical giant AstraZeneca
Pharmaceutical giant AstraZeneca temporarily suspends vaccine trial following voluntary illness

In a press release last week, the pharmaceutical giant stated that “we are committed to the safety of our participants and to the highest standards of our tests.”

Fourteen days after receiving the second dose of the vaccine, the woman, who lives in the UK, developed “confirmed transverse myelitis” with symptoms such as difficulty walking, pain and weakness, the safety report said. The researchers were worried that they might be exposed to what is known as SUSAR (that is, suspected or unexpectedly serious side effects).

What does the safety report say – What were the volunteer’s symptoms?

According to the AstraZeneca report, the patient received the first dose of the coronavirus vaccine in early June and was in good health. He received the second dose at the end of August.

On September 2, while driving, the “participant” stumbled (did not fall) along with a shake. “The report says she had no obvious injuries to her cervical spine.

The next day, according to the report, she had symptoms such as difficulty walking, pain and weakness in her arms and decreased sensation in the torso, headache and impaired ability to use her hands. The woman was in hospital on September 5.

The AstraZeneca report says twice that the woman was diagnosed with “confirmed” transverse myelitis. She also says that a neurologist who examined her “suggested that the symptoms were in line with the diagnosis of transverse myelitis.”

Doctor in coronavirus uniform

The report was sent to doctors conducting studies on the AstraZeneca vaccine. The cover of the report, sent by a project contractor employed by AstraZeneca, describes her illness as “confirmed” transverse myelitis. The contractor asked physicians if they were required to submit the report to their institutional audit committee or local ethics committee.

He felt better after four days

The report states that the woman went to a neurologist, who stated that the patient did not report a history of neurological symptoms or significant illness. Otherwise, the report states that “there was limited information about the individual’s medical history”. No other similar cases have been diagnosed among other volunteers, according to the report.

The neurologist found that the study volunteer began to feel better. “The resolution of her symptoms is quite rapid considering that her illness started just 4 days ago,” according to the report. “Her symptoms improved. Her strength and skill in her hands improved.”

AstraZeneca denies reports of transverse myelitis

On September 8, the New York Times reported, citing a source, that a volunteer for the test vaccine had transverse myelitis, and the next day Stat News reported that the company’s CEO, Pascalo Soriot, said the vaccine had been stopped because a woman who volunteered for the trial had symptoms of transverse myelitis.

Later in the day, AstraZeneca made the following statements: “Reports based on comments made earlier today by our CEO, who say that we have confirmed that a participant in the clinical trial developed transverse myelitis, are incorrect. He stated that there is no definitive diagnosis. “These tests will be submitted to an independent safety committee that will review the incident and determine the final diagnosis,” an AstraZeneca spokesman told CNN on September 9.

The woman took part in the British part of the clinical trial of the vaccine, which is run by the University of Oxford. When asked by CNN about her condition, AstraZeneca showed a participant newsletter that was updated on Oxford’s website on 11 September. This leaflet refers to test volunteers who “developed unexplained neurological symptoms, including a change in feeling or extreme weakness.”

The document goes on to say that “after an independent review, these diseases were considered unlikely to be associated with the vaccine or that there was insufficient evidence that the diseases were related to the vaccine or not.” He added that “close monitoring of the affected persons and other participants will continue.”

It is not clear why the Oxford Patient Safety Data Sheet refers to “unexplained neurological symptoms” and does not refer to transverse myelitis. It does not say whether the volunteer’s diagnosis was changed later.
Asked about this participant, a spokesman for the University of Oxford wrote in an email to CNN that “we can not disclose medical information about the disease due to patient confidentiality.”

Researchers question the transparency of clinical trials

With tens of thousands of participants, it is inevitable that some of them will fall ill during a trial, either from a cold or from cancer or a heart attack. After all, it is not always clear if a disease is associated with a vaccine.

How AstraZeneca reported the patient’s health condition and the condition of another who developed symptoms during the clinical trial of the vaccine has caused concern among some researchers who say that the pharmaceutical company is not completely transparent about how the coronavirus vaccine is tested.

On Monday, Kaiser Health News reported that an official from the National Institutes of Health expressed concern about the AstraZeneca vaccine process. As Dr. “AstraZeneca needs to be more careful about a possible complication of a vaccine that will eventually be given to millions of people,” said Avindra Nat, director of intramuscular clinical trials and director of viral research at the National Institute of Neurological Disorders. help, but the lack of information makes it difficult. ”

In a tweet last week, Dr. Eric Topol urged pharmaceutical companies conducting clinical trials with coronavirus vaccine to be more open to their work. “Coronavirus vaccine companies were not transparent.” A lot is at stake, “wrote Topol, vice president of Scripps Research in California.




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