US FDA lifts clinical hold on Novavax's combo COVID-flu shot

Source: msn/Reuters

8h


(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 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.


Read more: https://www.msn.com/en-us/health/other/us-fda-lifts-clinical-hold-on-novavax-s-combo-covid-flu-shot/ar-AA1tSLGu

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This means they can continue with their late-stage trials. If that goes okay, they just might be able to get something out next year.

Of course next year, they would probably end up battling "Bobby", so we'll see who will win - "big pharma" or 'bear-whale" guy.