The Food and Drug Administration is considering whether to continue a coronavirus vaccine trial by AstraZeneca that was suspended after a patient suffered spinal cord damage, causing the National Institutes of Health to investigate the problem.
“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, a division of NIH, told Kaiser Health News. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”
AstraZeneca is conducting a global trial of a vaccine developed with Oxford University. The British patient suffered spinal cord inflammation but is now out of the hospital for the injury.
Nath thought the patient’s condition could be transverse myelitis. But AstraZeneca has not confirmed that condition. Britain’s health regulation organization has reviewed the injury and has allowed the trial to continue in the United Kingdom.
Nath said AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people.”
Nath continued, “We would like to see how we can help, but the lack of information makes it difficult to do so.”
Any 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.
“So many factors 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.”
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