Agency ‘very concerned’ about side effect in AstraZeneca’s COVID-19 vaccine, NIH official says

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The NIH introduced an examination into the case and the FDA is deciding if it needs to 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 back cord. The trial was resumed in the U.K. Sept. 12 after gaining approval from the Medicines Health Regulatory Authority, the nations comparable to the FDA..

The NIHs examination is still in the “preparation phases,” Dr. Nath informed Kaiser Health News, and the firm has yet to get tissue or blood samples from the British client..

An authorities from the National Institutes of Health told Kaiser Health News Sept. 14 that the company is “very worried” about a time out in AstraZenecas COVID-19 vaccine trial due to a negative response in a U.K. patient..

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The examination may take a month or two, Dr. Nath said, and the FDA decreased to comment to Kaiser Health News about for how long it would take before it chooses whether the U.S. can resume the trial..

Maia Anderson –
Tuesday, September 15th, 2020
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” The highest levels of NIH are extremely concerned,” Avindra Nath, MD, intramural scientific director and a leader of viral research study at the National Institute for Neurological Disorders and Stroke, an NIH department, told Kaiser Health News. “Everyones hopes are on a vaccine, and if you have a major complication the entire thing could get hindered.”.

Its still unclear what precisely occurred to the patient, however AstraZeneca has stated the person is no longer hospitalized, Kaiser Health News reported..