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Novavax's trial of combo COVID-flu shot put on hold because of safety concerns
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Wed, 2024-10-16 09:56 — mike kraft
US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns The U.S. Food and Drug Administration has put Novavax's trial of an experimental COVID-flu vaccine combination on hold after one person who received the shot reported nerve damage, the company said on Wednesday. Reuters
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A participant enrolled in a mid-stage study of the vaccine reported symptoms of motor neuropathy, or damage to the nerve cells that control muscles or movement, last month.
The company said other trials of COVID-19 and flu vaccines had not shown any safety signal for motor neuropathy. It did not believe that it was established that the vaccine had caused the safety event, but was working to provide more information to the FDA.
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