<p>The US Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's Covid-influenza and its standalone flu vaccines after a safety concern was found unrelated to the combination shot, the company said on Monday.</p><p>Shares of the vaccine maker rose nearly 14% to $10.17 in premarket trading.</p><p>Novavax had announced the clinical hold on the trial last month after a participant who had received its Covid-influenza combination vaccine had initially reported symptoms of motor neuropathy, or damage to the nerve cells that control muscles or movement.</p><p>The person was given the vaccine in January last year as part of a mid-stage study.</p><p>The company 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.</p><p>Assessment showed the symptoms were not related to Novavax's shot, it said.</p><p>"The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine," said Novavax's chief medical officer Robert Walker.</p><p>Novavax said it will work with the clinical trial investigators and other partners to resume late-stage trial activities as quickly as possible.</p><p>The company is expected to report third-quarter results on Tuesday. </p>
<p>The US Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's Covid-influenza and its standalone flu vaccines after a safety concern was found unrelated to the combination shot, the company said on Monday.</p><p>Shares of the vaccine maker rose nearly 14% to $10.17 in premarket trading.</p><p>Novavax had announced the clinical hold on the trial last month after a participant who had received its Covid-influenza combination vaccine had initially reported symptoms of motor neuropathy, or damage to the nerve cells that control muscles or movement.</p><p>The person was given the vaccine in January last year as part of a mid-stage study.</p><p>The company 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.</p><p>Assessment showed the symptoms were not related to Novavax's shot, it said.</p><p>"The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine," said Novavax's chief medical officer Robert Walker.</p><p>Novavax said it will work with the clinical trial investigators and other partners to resume late-stage trial activities as quickly as possible.</p><p>The company is expected to report third-quarter results on Tuesday. </p>