(Reuters) -The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax’s COVID-influenza and its standalone flu vaccines, the company said on Monday.
Shares of the company rose about 9% in premarket trading.
Novavax had announced the clinical hold on the trial last month after a participant who had received the combination vaccine had initially reported symptoms of motor neuropathy, or damage to the nerve cells that control muscles or movement.
The vaccine maker said it had provided additional information to the FDA, which included a change in details of the participant’s symptoms to amytrophic lateral sclerosis, a condition that affects nerve cells in the brain and spinal cord.
Assessment showed the symptoms were not related to Novavax’s shot, it said.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Krishna Chandra Eluri)
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