Novavax shares plunge as firm says FDA has suspended two vaccinations

A health worker prepares a dose of the Novavax vaccine as the Dutch health organization begins the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.

Patrick Van Katwijk | Getty Images

Novavax said Wednesday that the Food and Drug Administration has put on hold its application for a combination Covid-influenza shot and a standalone flu vaccine, causing the company's shares to fall sharply.

The biotech company's shares fell nearly 20% on Wednesday. The so-called clinical suspension stems from a single report of nerve damage in a patient who received the combination shot in a Phase 2 trial that ended in July last year.

A clinical hold is an order issued by the FDA to a manufacturer to delay or suspend a planned clinical trial of a drug.

It is unclear whether the pause will impact Novavax's ability to initiate and publish Phase III trial data for these vaccines. Still, it appears to be a setback for the biotech company, which is scrambling to bring new products to market as demand for its Covid vaccine falls worldwide.

Novavax said it is working with the FDA to resolve the clinical hold on its combination shot and standalone flu vaccine. The company said other studies of its Covid and flu shots have not revealed any safety concerns related to the type of nerve damage reported in the patient.

Novavax said it does not believe there is a proven link that the vaccine caused the nerve damage in the patient, but said it is working to provide more information to the FDA.

“Our goal is to successfully resolve this matter and begin our Phase 3 trial as quickly as possible,” said Dr. Robert Walker, chief medical officer of Novavax, said in a press release.

Public health officials see Novavax's protein-based Covid vaccine as a valuable alternative for people who don't want to receive mRNA shots Pfizer And Modernwho use a newer vaccination method to teach cells to make proteins that trigger an immune response against Covid.

Novavax's shot, on the other hand, fights off the virus using protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.