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The pharmaceutical company did not reveal details about the reaction suffered, but did reveal an internal security report, which was accessed by CNN, identifies the volunteer as a healthy 37-year-old woman who developed “confirmed” transverse myelitis after receiving the second dose of the vaccine, having been hospitalized on September 5. Transverse myelitis is an inflammation that affects the entire spinal cord and blocks the transmission of nerve impulses.
Four days after hospitalization, the pharmacist rejected reports that a participant had been confirmed to have a rare neurological disease.
The document, titled “Initial Report” and dated September 10, describes how The study volunteer developed difficulty walking, weakness, arm pain, and other symptoms associated with transverse myelitis.
The document also mentions that the 37-year-old woman was observed by a neurologist who stated that the patient had no history of neurological symptoms or relevant diseases. However, elsewhere in the report, they were said to have “limited information on the subject’s relevant medical history.”
On September 9, AstraZeneca announced the suspension of vaccine testing worldwide, advancing only the identification of “a potentially unexplained illness”. “As part of the ongoing global randomized controlled trials of the Oxford coronavirus vaccine, our standard review process has caused a pause in vaccination to allow review of safety data. “the company said in a statement.
The document also reports rapid improvement by the volunteer. “The resolution of your symptoms is very fast, considering that you were ill only four days ago,” says the neurologist. “His symptoms were improving. The strength and agility of his hands were improving ”, he adds.
The report concludes that “after independent review”, the adverse reaction developed by the volunteer was considered “unlikely to be associated with the vaccine.”, or there was not enough evidence to say with certainty if the disease was related to the vaccine or not ”.
It is added in the document that no other similar case was diagnosed among the rest of the study volunteers, but they guarantee that “close monitoring of those affected and other participants will continue.”
Scientists question transparency
At a time when a vaccine is eagerly awaited, several scientists criticize the pharmaceutical company’s lack of transparency on the patient’s condition and on the course of the Covid-19 vaccine trial.
Experts argue that the suspension of testing is normal and only reflects scientific rigor. However, several factors have led to scientists questioning transparency to AstraZeneca. Last week, the pharmacist revealed that this is not the first interruption, revealing that there was a “brief hiatus” in July when another volunteer fell ill.
The company announced that it had learned that the first participant had an “undiagnosed case of multiple sclerosis,” which was deemed unrelated to the vaccine. However, he did not explain how they came to that conclusion or why they waited more than a month to go public.
AstraZeneca “needs to be more accessible to a possible complication of a vaccine that will eventually be administered to millions of people,” argues Avindra Nath, viral research leader at the National Institute of Neurological Diseases, quoted by CNN. “We would like to know how we can help, but the lack of information makes it difficult to do so,” she added, saying that the National Institutes of Health “are very concerned.”
“Everyone’s hope is in a vaccine and if there is a serious complication, it can go off the rails”Nath explained.
Experts also caution that transparency is important to convey confidence to the public. The lack of clarity can lead the population to doubt the vaccine and, consequently, decide not to take it.
“People won’t get a vaccine if they don’t trust science ”, explains expert Peter Hotez, arguing that what the pharmacist is doing “is really regrettable.” “There must be transparency. This is simply not acceptable, “he concluded.
In turn, a spokeswoman for AstraZeneca argued that, as sponsors of the study, “they cannot disclose medical information.” In a statement, the company also stressed that they are “committed to the safety of our participants and to the highest standards of conduct in our tests.”
After the specialists have analyzed the patient’s condition, The University of Oxford and the pharmaceutical company AstraZeneca resumed testing of the Covid-19 vaccine last Saturday, but in the United States, tests are still pending.
In an email sent to CNN, an AstraZeneca spokesperson assured that “the company will continue to work with health authorities around the world, including the FDA. [Food and Drug Administration] in the United States, and you will be informed when other clinical trials may resume. ”
