Novavax's COVID-influenza vaccine. Representative image.
Reuters File Photo
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.
Shares of the vaccine maker rose nearly 14% to $10.17 in premarket trading.
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.
The person was given the vaccine in January last year as part of a mid-stage study.
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.
Assessment showed the symptoms were not related to Novavax's shot, it said.
"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.
Novavax said it will work with the clinical trial investigators and other partners to resume late-stage trial activities as quickly as possible.
The company is expected to report third-quarter results on Tuesday.