The head of viral research at the NIH department’s National Institute for Neurological Disorders and Stroke, Dr. “The highest level of NIH is very worrying,” said Avindra Nath. “Everyone’s hope is on the vaccine, and if you have a big complication the whole thing can get off the rails.”
The frustration of people enthusiastically following the progress of vaccine testing leaves much uncertainty about what happened to the anonymous patient. AstraZeneca, who runs a global trial of a vaccine made at Oxford University, said the trial volunteer recovered from a severe inflammation of the spine and was no longer hospitalized.
AstraZeneca did not confirm that the patient had transverse myelitis, but Nath and other neurologists said they understood the case. Transverse mellitus forms a set of symptoms associated with inflammation of the spinal cord that can cause pain, muscle weakness, and paralysis. The UK’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, has reviewed the case and approved a retrial in the United Kingdom.
AstraZeneca “need[s] “The vaccine has to come up with a potential complication that will eventually be given to millions of people,” Nath said. “We should see how we can help, but the lack of information makes it difficult to do so.”
Any decision on whether to continue the trial is complicated because it is difficult to assess the cause of the rare injury that occurs during the vaccine trial – and scientists and officials have to consider the risk of unusual side effects against the vaccine that controls the epidemic. .
“A lot of decisions go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”
Nath said the NIH has yet to take tissue or blood samples from a British patient, and its investigation is at a “planned stage”. U.S. Scientists can look at samples from other vaccinated patients to see if they attack any of the antibodies produced in response to the coronavirus to brain or spinal tissue.
He said such a study takes a month or two. The FDA declined to comment on how long it would take before it decided to proceed.
Dr. Jesse Goodman, a professor and physician at Georgetown University who was the chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency would review the data and possibly consult with British regulators who are in the U.S. The study began only when the injury was reported, before being allowed to resume. The other two coronavirus vaccines are also available in the U.S. In the late-stage tests
If it determines that the injury in the British trial was caused by a vaccine, the FDA will suspend the trial. If it allows it to resume, regulators and scientists will definitely be on the lookout for similar symptoms in other trial participants.
The director of the Center for Multiple Sclerosis and Neuroimmunology at the University of Texas, Dr. According to Elliott Frohmann, the volunteer in the previous phase of the AstraZeneca trial had experienced similar side effects, but investigators found that she had multiple sclerosis that was not related to the vaccine, according to the University of Texas’ Multiple Sciences.
Neurologists who study diseases such as transverse mellitus say they are rare – occurring at a rate of 1 in 250,000 people – and strike largely as a result of the body’s immune response to the virus. Less frequently, such episodes are also associated with the vaccine.
The exact cause of this disease is the key to the decision taken by the authorities whether to resume the trial. Sometimes the underlying medical condition is “unmasked” by the person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial could be continued without fear, as the disease was not specific to the vaccine.
More worrying is an unusual phenomenon called “molecular mimicry”. In such cases, some small portions of the vaccine may resemble brain or spinal tissue, resulting in an immune attack on those tissues in response to the vaccine component. That being the case, if the trial is resumed, another case of transverse mellitus could be possible, said Vanderbilt University School of Medicine, an infectious disease specialist. Said William Scheffner. The second case will close the hearing, he said.
In 1976, when vaccinators began diagnosing a disorder similar to Guillain-Barr સિ syndrome, a large swine flu vaccination program was stopped. At the time, no one knew how common GBS was, so it was difficult to know if episodes were related to the vaccine.
“It’s very difficult to determine if a rare event has been caused by a vaccine,” Schaffner said. “How do you attribute the increased risk to something made in one in a million people?”
Goodman said the U.S. Before allowing the trials to resume, the FDA would like to see why it is safe to continue the company and the Independent Data and Safety Monitoring Board (DSMB) in the UK. There is a separate safety board for the AstraZeneca trial in the United States.
Goodman said FDA officials need to review the full details of the case and may request more information about the affected study volunteer whether to allow the U.S. hearing to continue. They may need AstraZeneca to update the safety information that participants provide for the study.
It is possible that the volunteer’s health problem was a coincidence not related to the vaccine, said Dr. Mash Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies on a single health problem usually do not stop, even if it is serious.
Yet many health leaders have expressed frustration that AstraZeneca has not released more information about the health problem that led to the suspension of its UK trial.
“There is very little information about this, it is impossible to understand what the diagnosis was or why the DSMB and the sponsor were assured that“ it was safe to continue, ”Goodman said.
AstraZeneca has said it is unable to provide further information about the health problem, saying it would violate the patient’s privacy, although it did not say how.
Leading scientists say there is an extraordinary need for transparency in the political climate discrepancy with the reluctance to vaccinate and the Trump administration’s lack of confidence in controlling the COVID-19 response.
“While I respect the essential need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues is.” “What was the diagnosis? If there was no clear diagnosis, what is it that makes them think the trial could be resumed? There is so much interest and potential concern about the COVID-19 vaccine that more information may be provided, more We have to guarantee. “
The FDA will need to balance the potential risks posed by the experimental vaccine with the threat posed by COVID-19, which has killed nearly 200,000 Americans.
“There are also potential consequences if you close the study,” Goodman said.
If the AstraZeneca vaccine fails, the US government is supporting six other COVID vaccines in the hope that at least one will succeed. Potential problems with the Al Strazeneca vaccine make this a prudent investment, Adalja said.
This is part of the idea that only one vaccine candidate will not come forward, he said. “It gives you a little more insurance.”
Schaffner said researchers need to remember that vaccine research is unpredictable.
“Investigators are inadvertently hyping their own vaccines,” Schaffner said. “Oxford investigators were out there this summer, ‘We’ll get there first.’ But this is exactly the reason … Dr .. [Anthony] Fu Ki and the rest of us have been saying, ‘You never know what will happen once you get into massive human trials.’
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