In this article, Novavax announced on Wednesday that the Food and Drug Administration (FDA) has placed a hold on its application for a combination shot targeting Covid and influenza, as well as a stand-alone flu vaccine. This news caused a significant drop in the company’s shares. The biotech company’s stock plummeted by nearly 20% on Wednesday. The FDA’s clinical hold was prompted by a single report of nerve damage in a patient who had received the combination shot during a phase two trial that concluded in July of the previous year.
A clinical hold is an FDA directive to a manufacturer to delay or halt a proposed clinical investigation on a drug. It remains uncertain whether this pause will affect Novavax’s ability to initiate and disclose data from phase three trials on these vaccines. Nevertheless, it represents a setback for the biotech company, which is striving to introduce new products to the market amidst a global decline in demand for its Covid vaccine.
Novavax stated that it is collaborating with the FDA to address the clinical hold on its combination shot and stand-alone flu vaccine. The company indicated that other trials involving its Covid and flu vaccines did not exhibit any safety issues related to the nerve damage observed in the aforementioned patient. Novavax clarified that it does not believe there is a confirmed link between the vaccine and the nerve damage, but it is actively working to provide additional information to the FDA.
Dr. Robert Walker, Novavax’s chief medical officer, expressed the company’s commitment to resolving the matter promptly and commencing its Phase 3 trial at the earliest opportunity. Public health authorities view Novavax’s protein-based Covid vaccine as a valuable option for individuals who prefer not to receive mRNA vaccines from Pfizer and Moderna. These mRNA vaccines employ a newer method to instruct cells in producing proteins that trigger an immune response against Covid.
In contrast, Novavax’s vaccine utilizes protein-based technology to combat the virus, a well-established approach employed in routine vaccinations against diseases like hepatitis B and shingles.
