FDA to lift hold over Novavax flu-shot program

Maryland-based biotech Novavax experienced a clinical hold on its late-stage trial of COVID-influenza and standalone flu vaccines after a severe adverse effect, in the form of motor neuropathy symptoms, was observed in one of the participants who received them in a mid-stage phase 2 trial in January of last year. The safety concerns were brought to light after Novavax disclosed the occurrence in a regulatory filing.

Testing for the vaccination was put on hold while the regulatory agency investigated the matter.

The symptoms exhibited by the patient were indicative of damage to the nerve cells that control movement and muscle, and it was recently concluded that the participant’s symptoms were signs of amyotrophic lateral sclerosis (ALS), a rare neurodegenerative disease that affects nerve cells in the brain and spinal cord.

As a result of the hold announced on the 16th of last month, shares for the company fell by 19%.

Since Novavax has been able to prove that the safety concern was unrelated to the combination shot, the Food and Drug Administration has decided to lift the hold, which also applied to the company’s flu-only programs. The agency claims that the company has satisfactorily addressed any concerns raised by them. The adverse event has been reclassified because additional information provided by Novavax shows that ALS was not known to be associated with the vaccination.

Robert Walker, Novavax’s chief medical officer, said in a statement, “The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible.”

Although the company has received a green light, Novavax has not clarified when results from the phase 3 trial can be expected but announced that trial activities will resume as soon as possible.

Novavax had aimed in the past to provide a protein-based alternative to the messenger RNA shots Moderna and Pfizer developed for COVID-19, but due to entering the market late, the company has experienced a slow uptake of its drug. This has resulted in the company having to cut down on staff and share value taking a hit.

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