FDA places hold on Novavax's combination Covid-flu shot and influenza vaccine, causing shares to plummet.

• The Food and Drug Administration has put a hold on Novavax's application for a combination shot targeting Covid and influenza and a standalone flu vaccine, causing shares of the company to plummet.
• The clinical hold was caused by a single report of nerve damage in a patient who received the combination shot during a phase two trial that ended in July 2020.
• The biotech company is facing a setback as demand for its Covid vaccine declines globally, making it difficult for the company to bring new products to market.

On Wednesday, the Food and Drug Administration placed a hold on Moderna's application for a combination shot targeting Covid and influenza, as well as a standalone flu vaccine, causing the company's shares to plummet.

On Wednesday, the biotech company's stock dropped nearly 20% due to a clinical hold resulting from a single report of nerve damage in a patient who received a combination shot in a phase two trial that ended in July 2020.

A clinical hold is a directive from the FDA to halt or postpone a planned clinical study on a drug.

The pause in Novavax's phase three trials may hinder the company's ability to release data on those vaccines, but it seems like a setback for the biotech company, which is struggling to bring new products to market as demand for its Covid vaccine declines globally.

Novavax is collaborating with the FDA to address the clinical hold on its combination and standalone flu vaccines. The company stated that other trials of its Covid and flu shots did not reveal any safety concerns related to the nerve damage reported in the patient.

Novavax stated that it does not believe the vaccine is responsible for the nerve damage in the patient, but it is working to provide additional information to the FDA.

Dr. Robert Walker, Novavax's chief medical officer, stated in a release that our objective is to promptly resolve this issue and commence our Phase 3 trial at the earliest opportunity.

Novavax's protein-based Covid vaccine is viewed as a valuable alternative by public health officials for individuals who do not wish to receive mRNA vaccines from Pfizer and Moderna, which employ a newer vaccine technique to instruct cells to produce proteins that elicit an immune response against Covid.

Meanwhile, Novavax's vaccine utilizes protein-based technology, which has been used in routine vaccinations against hepatitis B and shingles for decades, to protect against the virus.