Novavax shares plunge as company says FDA pauses two shots | Real Time Headlines

Novavax The U.S. Food and Drug Administration has paused its application for a combination injection of a targeted drug, it said Wednesday. coronavirus The flu and a stand-alone flu vaccine caused the company’s stock to plummet.

The biotech company’s shares fell nearly 20% on Wednesday. The so-called clinical hold was due to a single report of nerve damage in a patient who received the combination injection in a phase 2 trial that ended last July.

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

It’s unclear whether the pause will affect Novavax’s ability to launch and release data from Phase 3 trials of these vaccines. Still, it appears to be a setback for the biotech, which is scrambling to bring new products to market as global demand for COVID-19 vaccines plummets.

Novavax said it is working with the FDA to resolve clinical holds on its combination vaccine and standalone flu vaccine. The company said other trials of its coronavirus and flu vaccines did not show any safety concerns related to the type of nerve damage reported by patients.

Novavax said it does not believe there is a definite link between the vaccine and neurological damage in patients, but said it is working to provide more information to the FDA.

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

Public health officials consider Novavax’s protein-based Covid vaccine a valuable alternative for people who don’t want to take the mRNA shot Pfizer and modernwhich uses a newer vaccine approach to teach cells how to make proteins that trigger an immune response against the coronavirus.

Novavax’s vaccine, meanwhile, uses protein-based technology to protect against the virus, a decades-old approach used in routine hepatitis B and shingles vaccinations.