Novavax said Wednesday that the Food and Drug Administration has placed on hold its application for a mix Covid-influenza shot and a standalone flu vaccine, causing the corporate'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 mixture shot in a Phase 2 trial that led to July last yr.
A clinical hold is an order from the FDA to a manufacturer to postpone 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 recent products to market as demand for its Covid vaccine falls worldwide.
Novavax said it’s working with the FDA to resolve the clinical hold on its combination and single flu vaccine. The company said other studies of its Covid and flu shots haven’t revealed any safety concerns related to the variety of nerve damage reported within the patient.
Novavax said it doesn’t consider there may be a proven link that the vaccine caused the nerve damage within the patient, but said it’s working to supply 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 priceless alternative for individuals who don't wish to receive mRNA shots Pfizer And Modernwho use a more recent vaccination method to show cells to make proteins that trigger an immune response against Covid.
Novavax's shot, alternatively, fights off the virus using protein-based technology, a decades-old method utilized in routine vaccinations against hepatitis B and shingles.
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