Pharmaceutical company AstraZeneca suspended testing in the finals in early September, after one of the volunteers became ill.
The pharmaceutical company did not reveal details about the reaction suffered, but an internal safety report, to which the CNN had access, 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 was confirmed to have a rare neurological condition.
The document, entitled “initial report” and dated September 10, describes how the study volunteer developed walking difficulties, weakness, arm pain and other symptoms associated with transverse myelitis.
In the document, it is also mentioned 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, in another part of the report, it was said that they had “limited information about 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 controlled and randomized global trials of the Oxford coronavirus vaccine, our standard review process has triggered a pause in vaccination to allow review of safety data “, the company said in a statement.
The document also reports a rapid improvement on the part of the volunteer. “The resolution of your symptoms is quite fast, considering that you were sick 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 an 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 whether the disease was related to the vaccine or not ”.
It is added in the document that no other similar case was diagnosed among the remaining study volunteers, but they guarantee that “close monitoring of the affected individuals 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 tests is normal and only reflects scientific rigor. However, several factors have been leading the scientists questioning transparency to AstraZeneca. Last week, the pharmacist revealed that this is not the first interruption, revealing that there was a “brief pause” 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 considered unrelated to the vaccine. He did not, however, explain how they came to that conclusion or why they waited more than a month to make it public.
AstraZeneca “needs to be more accessible to a potential complication of a vaccine that will eventually be administered to millions of people”, defends Avindra Nath, leader of viral research at the National Institute of Neurological Diseases, cited by CNN. “We would like to know how we can help, but the lack of information makes it difficult to do so,” he 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 be derailed”, explicou Nath.
Experts also warn that transparency is important for transmitting confidence to the public. The lack of clarity can lead the population to doubt the vaccine and, consequently, decide not to take it.
“People will not get a vaccine if they don’t trust science ”, explains expert Peter Hotez, arguing that what the drugmaker is doing “is really unfortunate”. “There needs to be transparency. This is simply not acceptable, ”he concluded.
In turn, an AstraZeneca spokeswoman argued that, as sponsors of the study, “they cannot disclose medical information”. In a statement, the company also underlined that they are “committed to the safety of our participants and the highest standards of conduct in our tests”.
After the patient’s condition has been analyzed by specialists, Oxford University and pharmaceutical company AstraZeneca resumed testing the Covid-19 vaccine last Saturday, but in the United States, the tests are still pending.
In an email sent to CNN, an AstraZeneca spokesman assured that “the company will continue to work with health officials around the world, including the FDA [Food and Drug Administration] in the United States, and will be guided on when other clinical trials may be resumed. ”
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