Novavax's COVID-Influenza Vaccines Get FDA Approval

Investing.com — The U.S. Food and Drug Administration (FDA) has lifted its hold on a late-stage trial for Novavax’s combination COVID-influenza and standalone flu vaccines, as reported by the company on Monday (NASDAQ:MNDY).

The biotech firm’s shares jumped 13% in premarket trading following the announcement.

Novavax (NASDAQ:NVAX) previously disclosed that the trial had been paused after a participant who received the combination vaccine initially reported symptoms suggestive of motor neuropathy, which affects the nerves controlling muscle movement.

However, the company later submitted additional data to the FDA, clarifying that the participant’s symptoms were more accurately linked to amyotrophic lateral sclerosis (ALS), a neurological condition impacting nerve cells in the brain and spinal cord.

Novavax asserted that assessments found no connection between the symptoms and its vaccine. Robert Walker, Chief Medical Officer of Novavax, thanked the FDA for its thorough review, stating, "The information provided 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."

A clinical hold is an FDA directive instructing a drug manufacturer to delay or halt a planned clinical study; this action had previously caused a sharp drop in Novavax shares.

Novavax maintains that there is no confirmed link between its vaccine and the reported nerve damage in the patient. Public health officials view Novavax's protein-based COVID vaccine as a valuable option for those hesitant to receive the mRNA vaccines from Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA).

Unlike mRNA technology that prompts cells to produce proteins stimulating an immune response to COVID, Novavax’s method relies on protein-based technology, a well-established approach used for vaccines against diseases like hepatitis B and shingles.