![]() Less frequently, such episodes have also been linked to vaccines. Neurologists who study illnesses like transverse myelitis say they are rare-occurring at a rate of perhaps 1 in 250,000 people-and strike most often as a result of the body’s immune response to a virus. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.Ī volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. ![]() Two other coronavirus vaccines are also in late-stage trials in the U.S. study, which had just begun when the injury was reported. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. The FDA declined to comment on how long it would take before it decides whether to move forward.ĭr. Such studies might take a month or two, he said. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue. ![]() The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. The last thing you want to do is hurt healthy people.” “So many factors go into these decisions,” Nath said. “We would like to see how we can help, but the lack of information makes it difficult to do so.”Īny decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial-and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.ĪstraZeneca “need to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.ĪstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”Ī great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. ![]() “The highest levels of NIH are very concerned,” said Dr. The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.
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