“The highest levels of NIH are very concerned,” Avindra Nath, MD, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division, told Kaiser Health News. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”
The NIH launched an investigation into the case and the FDA is deciding if it should resume the AstraZeneca trial, which was halted by the drugmaker Sept. 9 after a patient in the U.K. suffered a severe inflammation of the spinal cord. The trial was resumed in the U.K. Sept. 12 after gaining approval from the Medicines Health Regulatory Authority, the country’s equivalent to the FDA.
It’s still unclear what exactly happened to the patient, but AstraZeneca has said the individual is no longer hospitalized, Kaiser Health News reported.
The NIH’s investigation is still in the “planning stages,” Dr. Nath told Kaiser Health News, and the agency has yet to get tissue or blood samples from the British patient.
The investigation may take a month or two, Dr. Nath said, and the FDA declined to comment to Kaiser Health News about how long it would take before it decides whether the U.S. can resume the trial.
Read the full article here.
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