A healthcare worker prepares a dose of the Novavax vaccine as the Dutch Health Services Organization begins the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.
Patricio Van Katwijk | fake images
Novavax on Wednesday said the Food and Drug Administration had suspended its application for a combination shot targeting Covid and influenza and a standalone flu vaccine, causing the company's shares to fall sharply.
Shares of the biotech company fell nearly 20% on Wednesday. The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination injection in a phase two 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 proposed clinical investigation of a drug.
It is unclear whether the pause will affect Novavax's ability to initiate and publish data on phase three trials of those vaccines. Still, it appears to be a setback for the biotech company, which is struggling to bring new products to market as demand for its Covid vaccine plummets around the world.
Novavax said it was working with the FDA to resolve the clinical suspension of its combination shot and standalone flu vaccine. The company said other trials of its Covid and flu vaccines had not shown any safety concerns related to the type of nerve damage reported in the patient.
Novavax said it does not believe there is an established connection that the vaccine caused damage to the patient's nerves, but said it is working to provide more information to the FDA.
“Our goal is to successfully resolve this matter and initiate our Phase 3 trial as soon as possible,” Dr. Robert Walker, Novavax's chief medical officer, said in a statement.
Public health officials see Novavax's protein-based Covid vaccine as a valuable alternative for people who do not want to receive mRNA shots. Pfizer and modernwhich use a newer vaccine method to teach cells how to make proteins that trigger an immune response against Covid.
Meanwhile, Novavax's vaccine defends the virus with protein-based technology, a method that has been used for decades in routine vaccinations against hepatitis B and shingles.
