Novavax shares plunge as company says FDA put hold on two shots

Novavax on Wednesday said the Food and Drug Administration has put a hold on its application for a mixture shot targeting Covid and influenza and a stand-alone flu vaccine, sending the corporate’s shares down sharply. 

The biotech company’s stock fell nearly 20% on Wednesday. The so-called clinical hold is as a result of a single report of nerve damage in a patient who received the mixture shot in a phase two trial that finished in July last yr. 

A clinical hold is an order issued by the FDA to a manufacturer to delay or suspend a proposed clinical investigation on a drug.

It’s unclear if the pause will impact Novavax’s ability to start out and release data on phase three trials on those vaccines. Still, it appears to be a setback for the biotech company, which is scrambling to bring recent products to market as demand for its Covid vaccine plummets worldwide.

Novavax said it was working with the FDA to resolve the clinical hold on its combination shot and stand-alone flu vaccine. The corporate said other trials of its Covid and flu shots had not shown any safety concerns related to the sort of nerve damage reported within the patient. 

Novavax said it doesn’t imagine there’s a longtime connection that the vaccine had caused the nerve damage within the patient, but said it’s working to offer more information to the FDA. 

“Our goal is to successfully resolve this matter and to start out our Phase 3 trial as soon as possible,” Dr. Robert Walker, Novavax’s chief medical officer, said in a release. 

Public health officials see Novavax’s protein-based Covid vaccine as a priceless alternative for individuals who don’t desire to take mRNA shots from Pfizer and Moderna, which use a more recent vaccine method to show cells make proteins that trigger an immune response against Covid.

Novavax’s shot, meanwhile, fends off the virus with protein-based technology, a decades-old method utilized in routine vaccinations against hepatitis B and shingles.