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NIH 'very concerned' about serious side effect in AstraZeneca coronavirus vaccine trial

September 15, 2020. Summarized by summa-bot.

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.

(Kaiser Health News)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.

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.

AstraZeneca "need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people," said Nath.

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.

Dr. 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. study, which had just begun when the injury was reported.

Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine.

Before allowing U. S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U. K. felt it was safe to continue, Goodman said.

FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U. S. trial to continue, Goodman said.

The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.

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